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Acronyms & glossary
The following terms, definitions & acronyms are used in Australian therapeutic goods regulation. They are provided as general information only and this is not intended to be an exhaustive list.
Refer to Australian therapeutic goods legislation for legal definitions and for other terms not included on this page.
Australian Approved Name (see TGA approved terminology for medicines)
Administrative Appeals Tribunal
Australian Business Number or Approved Biological Name
Refers to 'a country that the Minister has notified in the Gazette as an acceptable country for the purposes of this Regulation', as described by Regulation 16C of the Therapeutic Goods Regulations 1990.
Approved Cell and Tissue Name (see TGA approved terminology for medicines)
The Therapeutic Goods Act 1989
Active implantable medical device (AIMD)
An active medical device (other than an implantable medical device) that is intended by the manufacturer:
- to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
- to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
- to remain in place after the procedure.
The therapeutically active component in a medicine's final formulation that is responsible for its physiological action
Active medical device
A medical device that is intended by the manufacturer:
- to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
- to act by converting this energy; but
- does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted
Active pharmaceutical ingredient (API)
Means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the production of a medicine, becomes an active ingredient of that medicine. These substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. Defined in Therapeutic Goods (Manufacturing Principles) Determination 2020.
Active raw material
The unformulated active chemical substance, usually a powder or a liquid, in the form in which it is used to manufacture a dosage form, usually in combination with excipients
Australian Drug Evaluation Committee (replaced in 2010 by the Advisory Committee on Prescription Medicines (ACPM))
A drug or other substance that enhances the activity of another.
(in immunology) A component that potentiates the immune response to an antigen and/or modulates it towards the desired immune response.
(in chemotherapy) The use of anticancer drugs after, or in combination with, another form of cancer treatment (e.g. after surgical removal of a cancer. The method is used where there is a significant risk that undetected cancer cells may still be present.
Adverse Drug Reactions Advisory Committee (replaced in 2010 by the Advisory Committee on the Safety of Medicines (ACSOM))
In the context of guidance about adventitious agent safety of medicines and therapeutic goods that contain or are produced from human blood or plasma means:
An infectious agent that is introduced into a therapeutic good during collection of raw materials or the manufacturing process. Adventitious agents include mycoplasma (a type of bacteria), viruses and agents that cause transmissible spongiform encephalopathies (prions).
Adventitious agent safety
In the context of guidance about adventitious agent safety of medicines means:
The implementation of control processes to prevent adventitious agents entering therapeutic goods, or to reduce or inactivate adventitious agents that may be in the therapeutic goods during the manufacturing process. It applies to all medicines that contain, or are manufactured using, material of animal or human origin.
Adverse drug reaction (ADR)
See Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions
Adverse event (AE)
See Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions
Any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods (also see Advertising therapeutic products)
A person duly authorised in writing to act on behalf of the sponsor of the goods.
Approved Herbal Name (see TGA approved terminology for medicines)
Approved Herbal Substance Name (see TGA approved terminology for medicines)
As low as reasonably practicable
Refers to'includes examination and testing', as described by Regulation 2, Part 1(2) of the Therapeutic Goods Regulations 1990.
In relation to guidance about drug master files and certificates of suitability means:
A selective antimicrobial agent, other than disinfectants, antiseptics and substances solely used as antineoplastics, that, on application to living tissue or by systemic administration, kills or prevents growth of susceptible micro-organisms.
In relation to a medicine, means a shortage of the medicine that is anticipated to commence at a future date.
that is recommended by its manufacturer for:
- dermal application; or
application to the mucous membranes of a person or an animal:
- to kill micro organisms; or
- to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
- that is not represented to be suitable for internal use.
In the terms of the Therapeutic Goods Act 1989 – a person seeking a review of a decision under the provisions of Section 60C of the Therapeutic Goods Act 1989.
A person who has made an application, or is intending to make an application, pursuant to the Therapeutic Goods Act 1989, and who can provide evidence of this on request.
Made to the TGA under the following sections of the Therapeutic Goods Act 1989 (note that where the section/regulation number is highlighted, the word 'application' is used in the legislation):
- Section 9C (request for copy of ARTG entry); or
- Section 9D (request to vary information about and ARTG entry); or
- Section 14 (exemption from compliance with a Standard); or
- Section 19 (exemptions for special and experimental uses); or
- Section 23 (registration or listing) [note that each application results in a single registration or listing or the inclusion of a separate and distinct product within a grouped registration or listing]; or
- Section 37 (application for licence); or
- Section 58 (export certifications); or
- Section 61(6) (release of information); or
- Regulation 14 (transfer of goods registered/listed); or
- Regulation 14A (reassignment of registration / listing numbers).
(See also submission).
The term Application in relation to TGA's medicine registration process is the top group of a series of sequences for the same product (e.g. active ingredient). One Application is usually defined for the complete life cycle of the specific product. (See also eCTD).
Refers to separate and distinct goods included in the Australian Register of Therapeutic Goods (ARTG), as described by the criteria in Section 16(1) of the Therapeutic Goods Act 1989. Grouped goods represent two or more ARTG entries under a single ARTG number.
Relates to the basis of the goods inclusion in the ARTG. Goods are included in the Register as a mechanism indicating approval for supply in Australia and/or approval for export from Australia. Goods for export only will have an ARTG purpose of'export'; all others will have a purpose ofsupply'.
A term which describes the registration /listing status of therapeutic goods in relation to their inclusion, or otherwise, in the ARTG. It includes registered, listed, cancelled by Secretary and cancelled by sponsor.
Assisted reproductive technology
Additional trade name
In relation to cyber security: the different points (code, components, user functions, etc.) where a medical device is exposed to adversaries or other unauthorised modifications.
Australian Public Assessment Report
AUST L number
The unique ARTG number for a listed therapeutic product (also see: What's on a medicine label?)
AUST R number
The unique ARTG number for a registered therapeutic product (also see: What's on a medicine label?)
Australian Approved Name (AAN) for pharmaceutical substances
A name for an ingredient, or a plant or other organism included in the formulation of a medicine, which is included in the list of TGA Approved Terminology for Medicines published by the Therapeutic Goods Administration. The list comprises three parts:
- Chemical substances AAN list;
- Herbal substances AAN list; and
- Biological substances AAN list.
Australian Register of Therapeutic Goods (ARTG)
Maintained under s. 9A of the Therapeutic Goods Act 1989 for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans.
The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of the Regulations:
- an officer of the Department, of another Department or of an authority of the Commonwealth;
- an officer of:
- a Department of State of a State;or
- a Department or administrative unit of the Public Service of a Territory; or
- an authority of a State or of a Territory;
being a Department, unit or authority that has functions relating to health matters.
- in relation to any provision of the Act, a person authorised by the Secretary to exercise powers under that provision; or
- iin relation to a provision of Part 6-2, a member of the Australian Federal Police, or a Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901)
- in relation to RFS or RFFP, a person who is authorised through a statement in the manufacturer's PQS to perform RFS and/or RFFP.
Living tissue transferred from one part of a patient's body to another
The use of blood, blood components, tissues and cellular therapy products that are removed from and applied to the same person
The use of biologicals that are removed from and applied to the same person
Bacterial endotoxin limit
In the context of the microbial quality of prescription and over-the-counter medicines means:
The maximum allowable bacterial endotoxin content in a sterile medicine, as specified by default standard(s).
In relation to human cell and tissue products, the basic functions of the product are:
- those that are well understood (scientifically) to apply to the donor tissue
- where functionality can be assumed in the recipient, in the absence of a need to perform testing
A quantity of a product that is:
- uniform in composition, method of manufacture and probability of chemical or microbial contamination; and
- made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle
Biopharmaceutic Classification System
The quantity and characteristics of microorganisms present in, or on therapeutic goods, or to which they may be exposed to during manufacturing.
A thing that comprises, contains, or is derived from human cells or tissues; or comprises or contains live animal cells, tissues or organs; and is represented in any way to be, or is likely to be, for therapeutic use.
Biological medicine means:
- a medicine (other than an antibiotic) that is:
- a vaccine, a peptide, a protein, a polysaccharide; and
- derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
- of a kind specified in item 1 of Part 1 of Schedule 10; or
but does not include a 'biological' within the meaning of section 32A of the Act.
The study of the ways that the physical and chemical properties of drug substances, drug products and routes of administration affect bioavailability (the rate and extent of drug absorption). Biopharmaceutic studies of new medicines typically include the investigation of bioavailability, relative bioavailability and bioequivalence of different dosage forms or formulations, and the effect of food or antacids on their bioavailability.
Biosimilar is a version of an already registered biological medicine that has a demonstrable similarity in physicochemical, biological and immunological characteristics, efficacy and safety, based on comprehensive comparability studies.
Black hat adversaries
In relation to cyber security: groups or individuals who assess a target system to find its vulnerabilities (known or new), implement ‘exploits’ for these vulnerabilities and use exploits to attack the system with malicious motivation.
Blinding (also called masking) is a procedure in which one or more parties in a clinical trial are kept unaware of the treatment assignment(s). Blinding is used so that neither the patients' nor staff's expectations about the medicine or treatment under investigation can influence the outcome.
Whole blood collected from a single human donor and processed either for transfusion or further manufacturing
Means therapeutic components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing.
In relation to an advertisement or generic information, means any means (other than a means declared in the regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms
Bovine spongiform encephalopathy (see Transmissible spongiform encephalopathies (TSEs))
synonym for 'drug product'
The name of the person or corporation for which particulars are being supplied or which is making an application. It may be either the name registered with the Australian Securities Investments Commission, or the name of the person or persons who conduct the business. Trading names are not usually included in the business name for Australian applicants, but may be supplied in particular for overseas companies. Also referred to as the Client name / ID. (See also client.)
C of A
Certificate of Analysis - a certificate issued by the manufacturer of the product reporting the test results obtained for the specified lot(s) of product supplied.
Corrective and Preventative Action
Chemical Abstract Services
In depth description of the factors related to a disease, disorder or condition in a specific individual.
A study that starts with identification of people with the disease, disorder or condition of interest (the cases) and a suitable control group without the disease or outcome (the controls). The relationship of an attribute (medicine, treatment, exposure or risk factor) to the outcome of interest is examined by comparing the frequency or level of the attribute in the cases and in the controls. For example, to determine whether thalidomide caused birth defects, a group of children with birth defects (cases) could be compared to a group of children without birth defects (controls). The groups would then be compared with respect to the proportion exposed to thalidomide through their mothers taking the tablets. Case-control studies are sometimes described as being retrospective as they are always performed looking back in time.
Category A patient
A person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment (see Special Access Scheme)
Category B patient
All other patients that do not fit the Category A definition (see Special Access Scheme)
A method for growing cells outside of the body. For example, to sustain a population, to increase the number of cells (‘expanding’) or promote the production of new cell types
Certificate of a Pharmaceutical Product (CPP)
For medicinal products, the issue of a certificate by the TGA under the World Health Organisation (WHO) Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce. It is issued only for therapeutic goods that are medicines. It allows the country of import to ascertain the product's marketing status in Australia and whether it has been manufactured in compliance with GMP.
Certificate of Suitability of a Monograph of the European Pharmacopoeia (CEP)
A certificate provided to the manufacturer by the European Directorate for the Quality of Medicines & HealthCare to certify that the relevant monograph in the European Pharmacopoeia adequately controls the substance as manufactured by the company at the time the certificate was granted.
Certified Product Details (CPD)
A statement of product details, specifications and test methods generated by the sponsor at the request of the TGA.
The sum payable annually for activities identified under the Therapeutic Goods (Charges) Act 1989 (for example, registration, listing and manufacturing licence).
Chemically derived medicine
A medicine that contains an active ingredient that has been manufactured in whole, or in part, by chemical methods.
Committee for Medicinal Products for Human Use
A person or organisation having an involvement in the import, export, manufacture or supply of therapeutic goods. An enterprise can include sponsors, manufacturers and agents.
Identification code assigned by the TGA to a client
The quality of a study's outcome that convinces physicians to modify or maintain their current practice of medicine. The assessment of clinical significance is usually based on the size of the effect observed, the quality of the study that yielded the data, and the probability that the effect is a true one. Clinical significance is not the same as statistical significance; a finding in a study may demonstrate a statistical difference in an attribute under review but this may have no impact clinically.
Clinical trial (synonyms: clinical study, intervention study)
A planned study in humans of an intervention (including a medicine, treatment or diagnostic procedure) with the object of investigating safety or efficacy and designed to achieve at least one of the following:
- the discovery or verification of clinical, pharmacological or other pharmacodynamic effects
- the identification of adverse reactions or adverse effects
- the study of absorption, distribution, metabolism or excretion.
Refers to recording of working days by TGA.
Closed shelf life
The shelf life of a therapeutic good before opening of the immediate container in which the therapeutic good is supplied.
Certificate of Listed Product
Complementary Medicines Evaluation Committee (replaced in 2010 by the Advisory Committee on Complementary Medicines (ACCM))
A Cochrane Review is a systematic, up-to-date summary of reliable evidence of the benefits and risks of healthcare. For a review to be called a "Cochrane Review" it must be in the Parent database maintained by the Cochrane Collaboration. The Cochrane Collaboration is an international organisation that aims to help people make well-informed decisions about healthcare by preparing, maintaining and promoting the accessibility of systematic reviews of healthcare interventions.
In relation to the eCTD, the code version refers to the version of the defined list being referenced (the version attribute of the codes element therein).
Cohort study (synonyms: follow-up, incidence, longitudinal, prospective study)
An observational study in which a defined group of people (the cohort) is followed over time. The outcomes of people in subsets of this cohort are compared, (e.g. to examine people who were exposed or not exposed, or exposed at different levels, to a particular intervention or other factor of interest). A cohort can be assembled in the present and followed into the future (this would be a prospective study or a "concurrent cohort study"), or the cohort could be identified from past records and followed from the time of those records to the present (this would be a retrospective study or a "historical cohort study"). Because random allocation is not used, matching or statistical adjustment at the analysis stage must be used to minimise the influence of factors other than the intervention or factor of interest.
In relation to blood, blood components: the process of removing human blood, blood components, cells or tissue from a donor
In relation to biologicals: the process of removing a biological or a source of a biological from a donor
In relation to colourings used in oral medicines means:
An inactive substance that is used in oral formulations of medicines, for various reasons (e.g. To distinguish between strengths, indications or markings).
Combined collection of evidence
Refers to the collection of evidence items to support a primary clinical study or primary item of evidence, and when taken together they address all overarching concepts raised in the checklists for a particular indication.
Common Technical Document (CTD) format
An internationally agreed set of specifications for a submission dossier. The CTD format includes five modules that set out the requirements for a consistent, unambiguous and transparent dossier that can be easily navigated by TGA staff and evaluators. See Common Technical Document overview
In relation to biologicals, a dissected valve that is capable of functioning in a defined effective manner
Therapeutic goods consisting wholly or principally of one or more designated active ingredients, each or which has a clearly established identity and
- a traditional use OR
- any other use prescribed in the regulations
Schedule 14 of the Therapeutic Goods Regulations 1990 defines the following as 'designated active ingredients':
- an amino acid
- a choline salt
- an essential oil
- plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
- a homoeopathic preparation
- a microorganism, whole or extracted, except a vaccine
- a mineral including a mineral salt and a naturally occurring mineral
- a mucopolysaccharide
- non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
- a lipid, including an essential fatty acid or phospholipid
- a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
- a sugar, polysaccharide or carbohydrate
- a vitamin or provitamin
A medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any therapeutic devices. The medicinal products must be for use as a single treatment regimen. Examples include a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order, or a primary pack containing an active ingredient in one vial and a diluent in another vial, or a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment.
Composite pack [medical devices]
see Australian Regulatory Guidelines for Medical Devices
Composite pack [medicine]
A medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any medical devices. The medicinal products must be for use as a single treatment or as a single course of treatment, and it is necessary that the medicines be combined before administration or that they must be administered in a particular sequence
- a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order
- a primary pack containing an active ingredient in one vial and a diluent in another vial
- a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment
Computer Emergency Response Team (CERT)
Expert groups that provide assistance in handling cyber security incidents.
Validation carried out during routine production of batches intended for supply.
In relation to a person, any deviation(s) from the normal structure or function of the body, as manifested by a characteristic set of signs and symptoms.
Consequential change (to the product information)
A required change to the product information as a result of a variation to the Australian Register of Therapeutic Goods entry for that product.
In relation to a medicine, means the overall volume and timing needs of the consumer to access the medicine. For the purpose of medicine shortages, the assessment of the demand is limited to the availability to the overall Australian market and not the separate points of distribution.
Goods intended for personal, domestic or household use
Consumer Medicine Information (CMI)
Document required to be provided to patients with prescription medicines that gives a plain-English explanation of the product
In relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion
In relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion. Container types are independent of the material used to fabricate them.
Where all or part of the manufacturing process of therapeutic goods is carried out by a person other than the sponsor on a contract basis. Can include principal manufacturers and other (sub) manufacturers.
In clinical trials comparing two or more interventions, a control is a person in the comparison group that does not receive the medicine or treatment under evaluation. Instead that person receives a placebo, no intervention, usual care or another form of care. In case-control studies, a control is a person in the comparison group without the disease or outcome of interest.
Controlled clinical trial
Refers to a study that compares one or more intervention groups to one or more comparison (control) groups. Whilst not all controlled studies are randomised, all randomised trials are controlled.
Chronic Obstructive Pulmonary Disease
Blood which contains many different types of cells, including stem cells, taken from the umbilical cord
Means a body corporate that is:
- a foreign corporation; or
- a trading corporation formed within the limits of the Commonwealth or a financial corporation so formed.
Action to eliminate a detected deficiency or nonconformity. A correction can be made in advance of, or in conjunction, with a corrective action. There is a distinction between corrective action and correction. Corrective actions are taken to prevent reoccurrence, whereas corrections are made against individual examples of a core issue. A correction can be, for example, rework or regrade. (Based on ISO 9000 Clause 3.12.3).
Action to eliminate the cause of a deficiency or nonconformity and to prevent recurrence (based on ISO 9000 Clause 3.12.2). There can be more than one cause for a deficiency or nonconformity.
Corresponding state law
Means a State law declared by the regulations to correspond to this Act or the regulations, including such a law as amended from time to time.
Committee for Proprietary Medicinal Products
Critical process parameter - a process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality (ICH Q8).
Critical quality attribute - a physical, chemical, biological or microbiological property or characteristic that should be within an approved limit, range or distribution to ensure the desired product quality (ICH Q8).
Means all materials or supplies used in the manufacture of therapeutic goods which could have a direct impact on the quality, safety or function of the final goods
Critical medical device
A device that, when used as recommended by its manufacturer, is in a sterile condition on introduction into the human body
This is a research design in which subjects receive a number of treatments in sequence. Generally, this means that all subjects have an equal chance during the trial of experiencing both treatment and placebo dosages without direct knowledge, instead of either placebo or the treatment. Subjects may be transferred directly from one treatment to another or may have a washout period in between test treatments. This type of trial can be randomised so that all subjects don't get the alternative treatments in the same order.
Means suspended in a medium containing a suitable cryoprotectant and cooled according to a method which has been validated to allow maintenance for long periods
Clinical trial approval scheme (see Clinical trials)
Clinical trial notification (see Clinical trials)
Current end date of provisional registration
We can give time limited provisional approval to medicines which provide promise of a major therapeutic advance for the treatment of serious or life threatening conditions. The initial provisional registration is for two years with the possibility of two extensions of up to two years each. This makes the medicine available while the pharmaceutical company completes final clinical trials. As a condition of provisional registration, the company must agree to continue clinical trials and submit comprehensive evidence for review to the TGA. If they do not follow this plan, or submit this evidence, we can cancel the approval, or may not extend the provisional registration period in the interest of patient safety. The current provisional lapse date is the date the provisional registration expires, however it may be extended within the maximum six year period. It is anticipated that in general, provisionally registered medicines will transition to a standard, registration.
In relation to a medicine, means a shortage of the medicine that has commenced and is ongoing.
Custom-made medical device
A medical device that:
- is specifically made in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
- is intended to be used only in relation to a particular individual
The processes, techniques and technologies employed to defend medical devices and their associated systems from digital attacks or inadvertent misuse. This includes preventing unauthorised access, modification, misuse or denial of use of digital medical devices, and preventing the unauthorised use of information that is stored, accessed, or transferred to or from the medical device.
Data matrix code
A data matrix code is a type of two-dimensional code that can be read by a 2D scanner. It is a small square or rectangle with two solid edges, two dotted edges and pixelated light and dark areas within the matrix. There are no fixed shapes within the matrix.
Data processing device
Any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device.
A DataMatrix is data matrix code formatted in accordance with the Global Standards 1 (GS1) General Specifications.
Date of manufacture
For a biological: the date (day, month and year) on which the processing of the product, including the packaging, is completed
Device Electronic Application Lodgement (see TGA eBusiness services)
Has the same meaning as in the Administrative Appeals Tribunal Act 1975.
Under sections 3 of the Therapeutic Goods Act 1989 three pharmacopoeias are defined as 'default standards' used to specify the quality, method of manufacture and other aspects of therapeutic goods. These are the British Pharmacopoeia, European Pharmacopoeia and United States Pharmacopeia–National Formulary.
Non-fulfilment of a requirement; term is used in GMP manufacturing inspections (based on ISO 9000 Clause 3.6.2).
A person who has been given authority by the Minister or Secretary of the Department of Health and Ageing to exercise a power, which the Therapeutic Goods Act 1989 or the Regulations confer on the Minister/Secretary. Refer to Section 57 and Regulations 47 and 47A.
The process of removing minerals (e.g. calcium salts from bone) from tissue
The review of GMP documentary evidence for a manufacturer to ascertain an acceptable standard
Diagnostic goods for in vitro use
See Regulation 2 of the Therapeutic Goods Regulations. Relates only to therapeutic devices.
In relation to stability testing for prescription medicines means:
A sterile liquid, supplied as a component of some medicines or as a separate product, and intended for use in reconstitution/dilution of the drug product in preparation for administration (e.g. water for injections).
In relation to a patient, means continuous surveillance by direct measurement
Directions for use
Includes information on:
- appropriate uses of the therapeutic goods
- the method of administration or use of the goods
- the frequency and duration of treatment for each indication of the goods
- the use of the goods by persons of particular ages or by persons having particular medical conditions
In relation to a medicine, means that the sponsor has decided to cease supply of the medicine to the Australian market.
Any deviation or interruption of the normal structure or function of any part, organ or system (or combination thereof) of the body that is manifested by a characteristic set of symptoms and signs and whose aetiology, pathology and prognosis may be known or unknown.
- that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
- that is not represented by the manufacturer to be suitable for internal use
A derangement or abnormality of function.
Do not reuse symbol
The international recognised symbol described in ISO 15223:2007: - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied and means DO NOT REUSE. The synonyms for this symbol are "single use" or "use only once".
A person who, by receiving an organ or tissue transplant, donates the removed organ or tissue to another recipient
In relation to blood, blood components and biologicals: any source, whether living or deceased, of blood, blood components, cells or tissues
The pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet, cream (see TGA approved terminology for medicines)
The number of doses per given time period, the time that elapses between doses or the quantity of a medicine that is given at each specific time of dosing.
A collection of files and documents that contains data (administrative, quality, nonclinical and clinical) relating to a therapeutic good.
Neither the participants in a trial nor the investigators (outcome assessors) are aware of which intervention the participants are given during the course of the trial.
Drug master file (DMF)
Data on the manufacture, quality control and stability of a drug substance sourced from a third-party manufacturer that is used in the manufacture of a medicine.
Means the finished dosage form of a medicine prior to the packaging and release for supply steps in the manufacturing process.
being replaced by 'active substance'; synonym for 'active pharmaceutical ingredient'
Digital versatile disc
electronic Common Technical Document - an electronic standard for the Common Technical Document (CTD) providing the means for transferring information from pharmaceutical companies to agencies.
Australia - European Community mutual recognition agreement
ECRI classification system (UMDNS/IMDC)
The system devised by the Emergency Care Research Institute of the USA that consists of assigned nomenclature and corresponding 5 digit codes for an extensive range of medical equipment. This system has been renamed by ECRI as the Universal Medical Device Nomenclature System (UMDNS) with codes being called International Medical Device Classifications.
European Directorate for the Quality of Medicines and Healthcare
Export Only [medicines] Lodgement System (see TGA eBusiness services)
A relative concept referring to the ability of a medicine or treatment to achieve a beneficial clinical effect. This may be measured or evaluated using objective or subjective parameters.
Australia - European Free Trade Association mutual recognition agreement
Electronic Listing Facility (see TGA eBusiness services)
Enzyme-linked immunosorbent assay
An indicator measured in a patient or biological sample to assess safety, efficacy or another trial objective. Also defined as the final trial objective by some authors.
Extension of indication
The study of the distribution and determinants of health-related states or events in specified populations.
The essential principles set out the requirements relating to the safety and performance characteristics of medical devices (see the Australian Regulatory Guidelines for Medical Devices)
Means a committee:
- constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and
- which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.
European Union/International Congress on Harmonisation
The Rules Governing Medicinal Products in the European Union
A textbook based on a critical and systematic review of published data, not simply on the opinions of the author(s).
Any component of a finished dosage form other than an active ingredient (in some cases the distinction between an active ingredient and an excipient may not be clear cut, for example: sodium chloride used to adjust tonicity of an injection is an excipient).
Goods which might be considered to be therapeutic goods but which are specifically declared not to be by an Order of the Secretary (and therefore not subject to any requirements of the Act)
Therapeutic goods that are exempted from the requirements to be Registered or Listed, or are exempted from licensing requirements by the Therapeutic Goods Regulations
In relation to therapeutic goods, means a person exempted from the operation of Part 3-3 in relation to those goods by the Regulations.
Experimental purposes in humans
As used in the Therapeutic Goods Act and Regulations, refers to use of medicines or devices in clinical trials subject to approval under Section 19(1)(b) of the Therapeutic Goods Act or to notification under item 3 of Schedule 5A of the Regulations.
The date (month and year) after which the goods should not be used
In relation to cyber security: an instance where a vulnerability or vulnerabilities have been exercised (accidently or intentionally) by a threat and could impact the safety or essential performance of a medical device or use a medical device as a vector to compromise a connected device or system.
Export certificate (devices)
A certificate issued for therapeutic devices equivalent to the WHO Certificate of a Pharmaceutical Product.
See Section 58 of the Therapeutic Goods Act. Can include a WHO Certificate of a Pharmaceutical Product for medicines, a Certificate of Free Sale (Devices) or an Export Certificate (Devices).
The proprietary name used for the goods for supply in another country where that name is different from the proprietary name used for the goods for supply in Australia
Export only medicine
- is manufactured in Australia for export only, or imported into Australia for export only; and
- is listable goods only because it is so manufactured or imported (and not for any other reason)
in relation to the recall of therapeutic goods, means how the failure will be presented
in relation to the recall of therapeutic goods, means the frequency with which the failure occurs for the affected stock
A sum payable for activities or events identified in Schedule 9 of the Regulations to the Therapeutic Goods Act 1989 (for example, evaluation fee).
Form Fill Seal
Agreed specification of the target volume of a drug product in the final container.
means a financial corporation within the meaning of paragraph 51(xx) of the Constitution.
Finished dosage form
synonym for finished product
Medicinal product when all stages of manufacture except for release for supply have been completed.
Faecal microbiota transplant (FMT) product means a thing that:
- comprises, contains or is derived from human stool; and
- is for introduction into a person for a therapeutic use.
The Freedom of Information Act 1982.
Means a foreign corporation within the meaning of paragraph 51(xx) of the Constitution.
A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch
To dry (food, blood, serum, etc.) while frozen and under high vacuum, as for prolonged storage
Gazetted therapeutic goods group
A group of medicines which have common characteristics, that are identified in an order published in the Commonwealth Government Notices Gazette (see Groups orders)
The Therapeutic Goods Regulations 1990, Regulation 2, defines a generic medicine as'a medicine that, in comparison with a registered medicine:
- has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine or previously registered medicine; and
- has the same pharmaceutical form; and
- is bioequivalent; and
- has the same safety and efficacy properties
Genetically modified organism (GMO)
The Gene Technology Act 2000 defines a GMO as:
- an organism that has been modified by gene technology; or
- an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
- anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;
but does not include:
- a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
- an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.
Genetically modified product
The Gene Technology Act 2000 and the Office of the Gene Technology Regulator defines a genetically modified product.
Global Medical Device Nomenclature (GMDN)
A collection of internationally recognised terms used to accurately describe and catalogue medical devices, in particular, those products used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Good Laboratory Practice
The approval of GMP documentary evidence that shows a manufacturer is of an acceptable standard
GMP or technical agreement
A written contract to meet the requirements of chapter 7 of the PIC/S Guide to GMP covering:
- the manufacture and/or analysis arranged under contract
- any technical arrangements made in connection with meeting the requirements of Chapter 7
Good clinical practice
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
Good manufacturing practice (GMP)
The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality. A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process. (Also see: Good manufacturing practice for therapeutic goods)
Grouped therapeutic goods
Medicines, devices or kits grouped under the one ARTG number (not to be confused with gazetted therapeutic goods group which only refers to medicines)
In relation to guidance on fees and charges for prescription medicines means:
The mechanism whereby goods, which would normally be required to be included in the ARTG under different ARTG registration or listing numbers (because they are separate and distinct by virtue of S 16(1) of the Therapeutic Goods Act 1989, may be included in the ARTG under the one ARTG registration or listing number, thereby attracting a single annual charge for the group of goods. Each product (as defined by S 16(1)) is still regarded as a separate ARTG entry and all controls under the Therapeutic Goods Act 1989 apply discretely to each separate and distinct product (for example: application fees; conditions; cancellation).
In relation to the manufacture of medicinal products, grouping is the scientifically justified selection of a group of products to be considered together for activities such as process validation, ongoing stability testing or product quality reviews.
Gene and Related Therapies Research Advisory Panel
a type of recall action that is issued for an implanted therapeutic good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted goods (medical devices or biologicals) cannot be recalled
Hepatitis B surface antigen
Hepatitis B virus
Herbal component name
Human cellular and tissue therapies
Hepatitis C virus
All or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):
- that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and
- that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form
Human Immunodeficiency Virus
TG Act - a preparation:
- manufactured from a mother substance; and
- manufactured in accordance with a manufacturing procedure described in a homoeopathic pharmacopoeia.
TG Regs - a preparation:
- formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
- prepared according to the practices of homoeopathic pharmacy using the methods of:
- serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
- serial trituration in lactose.
Is use of human cells or tissues to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected (donor).
For more information: Intended use: interpretation of homologous use
Haematopoietic progenitor cells-apheresis
Haematopoietic progenitor cells-cord
Haematopoietic progenitor cells-marrow
Haematopoietic progenitor cells: cells that are primitive multipotent cells capable of self-renewal as well as differentiation and maturation into all haematopoietic lineages
High Performance Liquid Chromatography
Human research ethics committee. More information: National Health and Medical Research Council
Hormone replacement therapy
Human T-lymphotropic viruses type 1
A live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro-nuclei or the initiation of its development by other means
Human embryonic stem cell
Undifferentiated cells, derived from a human embryo, that have the potential to become a wide variety of specialised cell types
Heating Ventilation and Air Conditioning - air handling systems used in production facilities including appropriate filters.
ICH Harmonised Tripartate Guidance Structure and Content of Clinical Study Reports
International Commission on Radiological Protection
In relation to impurities in drug substances is an impurity for which a structural characterisation has been achieved, as defined in Note for guidance on impurities testing: impurities in new drug substances ICHQ3A(R) (CPMP/ICH/2737/99).
In relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person as defined in Regulation 2 of the Therapeutic Goods Regulations.
Implantable medical device
a medical device (other than an active implantable medical device) that is intended by the manufacturer:
- to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
- to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
- to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure
Included in the Register
In relation to a medical device to which Chapter 4 of the Therapeutic Goods Act 1989 applies, means included in the ARTG
Note: For medical devices to which Chapter 4 applies, see section 41BJ of the Act.
Means the specific therapeutic uses of the goods
Individual patient data
In relation to therapeutic goods, means information, derived from clinical trials, relating to individuals before, during and after the administration of the goods to those individuals, including, but not limited to, demographic, biochemical and haematological information.
In relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment
Inhalation and nasal medicines
In relation to guidance on inhalation and nasal medicines applies to:
Medicinal products intended for delivery of the drug substance into the lungs, or to the nasal mucosa, with the purpose of evoking a local or systemic effect, as defined in Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (EMEA/CHMP/QWP/49313/2005).
Means a decision of the Secretary or of a delegate of the Secretary. Section 60 of the Act sets out the types of decisions that are considered 'initial decisions'.
International Numbering System (for food additives)
Systematic, independent and documented process for obtaining inspection evidence and evaluating it objectively to determine the extent to which the inspection criteria are fulfilled (based on ISO 19011 - Clause 3.1).
Outcome of an inspection, provided by the inspection team after consideration of the inspection objectives and all inspection findings (based on ISO 19011 - Clause 3.5).
Set of policies, procedures or requirements (based on ISO 19011 - Clause 3.2) used as a reference against which inspection evidence is compared.
Records, statements of fact or other information, which are relevant to the inspection criteria and verifiable (ISO 19011 - Clause 3.3).
Results of the evaluation of the collected inspection evidence against inspection criteria (based on ISO 19011 - Clause 3.4).
Extent and boundaries of an inspection (based on ISO 19011 - Clause 3.13), which generally includes a description of the physical locations, organisational units, activities and processes, as well as the time period covered.
The documented verification that the facilities, systems and equipment, as installed and modified, comply with the approved design and the manufacturer's recommendations.
Of a kind of medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:
- the information provided with the device; or
- the instructions for use of the device; or
- any advertising material applying to the device
Partly processed material from a manufacturer with a current TGA licence or GMP clearance that must undergo further manufacturing steps before it becomes a bulk product.
Internet of Things (IoT)
A term that describes the physical devices that connect to the internet and to each other. The IoT includes medical devices that may be connected to other medical devices or to other internal (to an organisation) or external networks.
Invasive medical device
A medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the body of a human being through a body orifice or through the surface of the body
Individual patient data
IVD or IVDD
In vitro diagnostic device
Joint Expert Technical Advisory Committee on Antibiotic Resistance
An inspection carried out at a single manufacturing site by two or more inspecting organisations (based on ISO 9000 Clause 3.13.3)
listed as either medicine or device kits. A package and therapeutic goods in the package together constitute a kit for the purposes of the Therapeutic Goods Act 1989 if:
- the package and the therapeutic goods are for use as a unit; and
- each item of the therapeutic goods consists of goods that are registered or listed or are exempt goods in relation to Part 3-2; and
- the package and therapeutic goods do not constitute a composite pack or a system or procedure pack.
In relation to biologicals, a person knowledgeable about the donor’s medical and social history, if the donor is deceased or unable to participate in an interview. A knowledgeable historian may be a person, or persons, able to provide relevant information and may be the donor's next of kin; the nearest available relative; a member of the donor's household; a person with a relationship to the donor (e.g. carer, friend, partner); or the donor's primary treating physician.
Means a display of printed information:
- on or attached to the goods; or
- on or attached to a container or primary pack in which the goods are supplied; or
- supplied with such a container or pack
Limulus amoebocyte lysate
Structural element of an eCTD submission delivering a document. It provides the link information to the document along with the title associated with the linked content.
A condition where the prominent feature (i.e. affecting an important portion of the target population) is serious illness from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of treatment based on mortality and life expectancy data.
Therapeutic goods that are required by the Act to be included in that part of the ARTG relating to Listed goods
Therapeutic goods that are included in the part of the ARTG for goods known as Listed goods
In relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27 of the Act. See Aust L number.
Locally acting products
As used in Biopharmaceutic studies guidance for prescription medicines:
Products which are applied locally, and are assumed to exert their effect at the site of application; systemic action, if any, would be considered as an undesired effect.
- dermatological products (e.g. Creams, ointments);
- inhalatory products (e.g. Powders or aerosols for inhalation);
- eye drops;
- ear drops;
- nasal products;
but also orally, vaginally, or rectally applied products which act locally.
Any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions
Major therapeutic advance
An improvement in the safety and/or efficacy of the medicine that is of a magnitude well beyond the minimum threshold of clinical significance.
The impact on patient outcomes for the indicated population will take into account effects on both efficacy and safety. The magnitude of the demonstrated improvement in safety and/or efficacy will be assessed in relation to other therapeutic goods registered for the indicated population. For provisional determination or registration this means that there is preliminary clinical data demonstrating that the medicine is likely to provide a major therapeutic advance.
In relation to guidance on fees and charges for prescription medicines means a change to:
- the strength, as recorded in the entry in the Register; or
- the dosage, the recommended dose regimen or the maximum daily dose; or
- the dosage form; or
- the route of administration; or
- the intended patient group.
In relation to cyber security: software designed with malicious intent to disrupt normal function of a system or device, gather sensitive information, and/or access other connected systems.
The production of medicines or any part of the process of producing medicines or bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process
Corporation or person carrying out one or more of the steps specified in the definition of manufacture
Manufacturer of a medical device
- The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations.
If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person's name, does one or more of the following using ready-made products:
- assembles the device;
- packages the device;
- processes the device;
- fully refurbishes the device;
- labels the device;
- assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:
- the labelling on the device;
- the instructions for using the device;
- any advertising material relating to the device.
However, a person is not the manufacturer of a medical device if:
- the person assembles or adapts the device for an individual patient; and
- the device has already been supplied by another person; and
the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:
- the labelling on the device;
- the instructions for using the device;
- any advertising material relating to the device.
A certificate issued by a regulatory authority to a specific manufacturing site, outlining the manufacturing operations for which the site is authorised and stating the GMP compliance status of the site at a particular point in time.
Examples of manufacturing certificates:
- Certificate of Good Manufacturing Practice (GMP)
- Certificate of GMP Compliance of a Manufacturer
- GMP Certificate
A licence granted under Part 3-3 of the Therapeutic Goods Act 1989 relating to manufacturing therapeutic goods.
The Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans. The manufacturing principles may relate to:
- the standards to be maintained, and the equipment to be used, at premises used for the manufacturing of therapeutic goods for use in humans; or
- procedures for quality assurance and quality control to be employed in the manufacturing of therapeutic goods for use in humans; or
- the qualifications and experience required of persons employed in the manufacture of therapeutic goods for use in humans; or
- the manufacturing practices to be employed in the manufacturing of therapeutic goods for use in humans; or
- other matters relevant to the quality, safety and efficacy of therapeutic goods for use in humans that are manufactured in Australia;
and may include codes of good manufacturing practice. See Section 36 of the Therapeutic Goods Act 1989.
Premises that are for use in the manufacture of a particular kind of therapeutic good, and at which the same persons have control of management of production of the goods and procedures for quality control.
The approval given to supply a therapeutic good in Australia, involving entry on the ARTG.
The marketing authorisation includes the details of the product in the ARTG, as well as all other matters in relation to product registration, listing or inclusion agreed in writing between TGA and the sponsor, and any other requirements imposed by a relevant Delegate of the Secretary upon ARTG entry.
Material of animal or human origin
Any component derived from animals or humans that is contained in, or involved in the manufacture of, the therapeutic goods, including:
- cell lines;
- embryonated chicken eggs;
- materials used in cell culture media;
- deer velvet antler;
- amino acids; and
- some excipients such as gelatin.
Master Cell Bank
Medicines Evaluation Committee (replaced in 2010 by the Advisory Committee on Non-prescription Medicines (ACNM))
A person who is registered, in a State or internal Territory, as a medical practitioner.
The name applied by the ARTG to any one item within a composite pack.
a product that is a medicine
- therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human; and
- any other therapeutic goods declared by the Secretary, for the purpose of the definition of therapeutic device, not to be therapeutic devices
A medicine shortage occurs when the supply of a medicine in Australia is unlikely to meet normal demand for consumers who need to take the medicine for a period of time.
The legal definition is as follows:
There is a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.
A planned meeting that is requested by a sponsor or applicant, including meetings conducted in any format (i.e. face to face, teleconference or videoconference).
Microbial contamination, extrinsic
Contamination of the product caused by compromised processing
Microbial contamination, intrinsic
Contamination of the product already present in the starting material
Cells and tissues have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.
For more information: Method of preparation: interpretation of minimal manipulation
For therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to:
- the formulation, composition or design specification; or
- the container for the goods; or
- any other attribute of the goods that results in the goods being separate and distinct.
Manufacturer's Master File
Memorandum of Intention
A product of the process of solution, extraction or trituration, from which homoeopathic preparations are made
Memorandum of Understanding
Mutual Recognition Agreement
Intended for use on more than one occasion.
Mutual Recognition Convention
The Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products, founded in Geneva on 8 October 1970. Commonly known as the Pharmaceutical Inspection Convention (PIC).
As used in relation to differentiation between therapeutic goods in Section 16 of the Therapeutic Goods Act 1989. May include the brand name, a descriptor of the goods or generic name together with a sponsor name or logo or banner name of a product range, that is, all elements which, together, serve to make the product recognisable as a particular item of commerce or supply.
Name of the goods
The non-proprietary name including the name of the dosage form or a synonym for the name of the dosage form, used to describe the goods in a specific standard. Listing and registration names include the name of the goods but may include further information to differentiate between forms of presentation.
In the context of the microbial quality of prescription and over-the-counter medicines means: a medicine that contains a raw material(s) of natural origin (animal, vegetal or mineral) where the raw material has not been fully processed.
New Biological Entity
Non-eCTD Electronic Submission - an alternative electronic standard to eCTD consisting of PDF Files and PDF Table of Contents linking all content for navigational purposes.
New chemical entity (NCE)
- A chemical, biological or radiopharmaceutical substance that has not previously been included in the ARTG; or
- an isomer, mixture of isomers, complex, derivative or salt of a registered chemical substance that, having previously been included in the ARTG, differs from the registered substance in having different safety or efficacy properties; or
- a biological substance that, having previously been included in the ARTG, differs from the registered substance:
- in having a different molecular structure; or
- in deriving from source material of a different nature or from a different manufacturing process; or
- a radiopharmaceutical substance that
- is a radionuclide or ligand that has not previously been included in the ARTG; or
- has a coupling mechanism, linking the molecule and radionuclide, that has not previously been included in the ARTG; or
- a fixed combination of active substances that have not previously been included in the ARTG as that fixed combination.
New indications medicine
A prescription medicine that:
- has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the ARTG; and
- does not have the same indications as that other medicine.
New prescription medicine
A prescription medicine that contains:
- a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the ARTG; or
- a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the ARTG
New safety data
Information that might negatively influence the benefit-risk assessment of a medicine or would be sufficient to consider changes in medicinal product administration
In relation to eCTD, additional heading structures beyond those defined by the specifications - generally equated to an additional subfolder in a defined section.
A device that only comes in contact with intact skin or does not come in contact with the human body.
The name used to describe the goods (particularly medicines) in a specific standard, including the name of the dosage form (if no standard exists, a name may comprise the AAN of the active ingredient and the name of the dosage form)
A type of action taken if therapeutic goods meet all specifications and standards and there are no deficiencies in safety, quality, efficacy, performance or presentation.
The preclinical, pharmaco-toxicological and pharmacological or toxicological studies.
Non-fulfilment of a requirement (based on ISO 9000 Clause 3.6.9); term is used in medical device manufacturer audits.
In relation to impurities in drug substances is a monograph that either does not have a test for impurities or, if it does have such a test, does not list those impurities.
Advice to the TGA in accordance with the requirements of:
- Section 29A (information about registered goods different from previously given);
- Section 29B (adverse effects of goods -registration application withdrawn);
- Section 9D (variation to goods which may be notified as specified in guidelines);
- Schedule 5A item 3 (clinical trial);
- Regulation 13 (change in sponsorship);
- Regulation 21 (change in QC manager -licensed promises);
- Regulation 22 (change of licence holder).
In relation to guidance on microbial quality of prescription and over the counter medicines means:
A microorganism that is not specified in Therapeutic Goods Order No. 100 - Therapeutic Goods (Microbiological Standards for Medicines) Order 2018, or in the default standards, but which might pose a risk if it is present in a medicine.
Data supporting the existence or verity of something (ISO 9000 Clause 3.8.3). Objective evidence can be obtained through observation, measurement, test, or other means. For the purpose of an inspection, objective evidence generally consists of records, statements of fact or other information, which are relevant to the inspection criteria and verifiable.
[TGA] Office of Complementary Medicines
[TGA] Office of Devices, Blood and Tissues (replaced in 2010 by the Office of Devices Authorisation (ODA))
Organisation for Economic Co-operation & Development
A person who has appropriate qualifications and experience to be an official analyst for the purposes of the Regulations approved by the Secretary under regulation 25 of the Therapeutic Goods Regulations.
A sample of goods taken under the provisions of Part 5 of the Therapeutic Goods Regulations. A certificate of official analyst is issued.
[TGA] Office of Laboratories and Scientific Services (previously known as TGA Laboratories (TGAL))
Office of Medicines Authorisation (formerly Office of Prescription Medicines and Office of Non-Prescription Medicines)
[TGA] Office of Manufacturing Quality (previously known as Manufacturers Assessment Branch (MAB))
[TGA] Office of Medicines Safety Monitoring (previously known as Adverse Drug Reactions Unit (ADRU) and replaced in 2010 by the Office of Product Review (OPR))
Ongoing stability program
A program to monitor the stability of a marketed product over its shelf life.
[TGA] Office of Non Prescription Medicines (replaced in 2010 by the Office of Medicines Authorisation (OMA))
out-of-specification - test results that fall outside the specifications or acceptance criteria that have been specified.
out-of-trend - test results that are within specification or acceptance criteria, but fall outside the range of values expected, when viewed alongside historical results or results obtained for comparable lots of material.
Open shelf life
The shelf life of a therapeutic good once the immediate container, in which the therapeutic good has been supplied, has been opened.
Refers to a single use device where the packaging has been damaged or opened but the device not used and/or did not come in contact with blood, tissue or body fluids
The documented verification that the facilities, systems and equipment, as installed and modified, perform as intended throughout the intended operating ranges.
[TGA] Office of Prescription Medicines (previously known as Drug Safety and Evaluation Branch (DSEB) and replaced in 2010 by the Office of Medicines Authorisation (OMA))
A medicine, vaccine or in vivo diagnostic agent that meets the requirements of regulation 16J of the Therapeutic Goods Regulations 1990. See regulation 16Jof the Therapeutic Goods Regulations 1990 for full criteria.
Other therapeutic goods
Increased content of drug substance, usually due to loss of potency on storage.
Increased volume of drug product to account for loss during delivery.
The size of the goods in terms of the quantity contained in the container (e.g. volume in a multi-use container) and/or the number of items in the primary/unit pack (e.g. number of tablets in a bottle)
Any material employed in the packaging of a medicinal product, excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
Any packaging or labelling process (including repackaging and labelling, overlabelling and supplementary labelling) where the medicine is already in the primary container, and that primary container is not opened, breached or modified in the secondary packaging process.
Provisional ARTG record
The Parliamentary Secretary for Health, who assists the Minister for Health by assuming responsibility for the TGA.
Partially processed goods
Therapeutic goods whose manufacture has not been completed to the stage of final packaging and labelling.
Physical or psychological injury or damage to the health of patients, including death.
Patient information document
See Consumer Medicine Information.
Portable document format
Section 4AA of the Crimes Act 1914 provides a definition of 'penalty unit'
The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.
Positron emission tomography
A Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans' Entitlements Act 1986 as defined inRegulation 2 of the Therapeutic Goods Regulations.
In relation to blood, blood components or biologicals: means a clinical inspection of a living or deceased potential donor to determine suitability of the person to be a donor and may include, but is not limited to, assessing the relevance of any abrasion/laceration, bruise/haematoma, fracture, tattoo, piercing, scar, skin lesion, surgical incision or other distinguishing external feature that may be indicative of a behaviour or lifestyle or suggestive of any risk factor in relation to a relevant communicable disease.
An inactive substance or treatment that supposedly has no treatment value. It is given to participants in clinical trials as a control against which to compare the effects of the test substance. In practice, placebos may also have positive or negative effects on trial participants.
The liquid part of uncoagulated blood or lymph, as distinguished from the corpuscles
Plasma master file
A compilation of all the required scientific data on the quality and safety of human plasma relevant to medicines, medical devices and investigational products that use human plasma in their manufacture. These data cover all aspects of the use of plasma, from collection to plasma pool.
Can mean Plasma Master File or Plant Master File depending on the context
The legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), it is a Legislative Instrument consisting of decisions regarding the classification of medicines and poisons into Schedules. Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.
Investigations of a disease or condition using subjects from a defined population. A population is a closely distributed grouping from a single community that is characterised by both genetic and cultural continuity through several generations.
In relation to a medical device, means that the basic risk of the device, before deliberate measures have been taken to minimise risk by inherent design or protection mechanisms, is considered intolerable
Pre-submission planning form
Product Quality Review - a periodic or rolling quality review of all licensed medicinal products.
Pharmaceutical Quality System - updated terminology for QMS, used in the PIC/S Guide to GMP.
Preliminary Clinical Data
In relation to medicines, means data based on controlled studies conducted according to internationally recognised standards establishing that the medicine has an effect on a surrogate, clinical or other early endpoint that is reasonably likely to predict clinical benefit.
- a structure, building, aircraft, vehicle or vessel; and
- a place (whether enclosed or built upon or not); and
- a part of a thing referred to in (a) or (b).
Prescribed quality and safety criteria
See Section 26(1)(k) of the Therapeutic Goods Act 1989. Quality and safety requirements prescribed in the Regulations for particular listable goods or categories of listable goods.
(other than where it is a substitute medicine) means a registered therapeutic good included in the ARTG that:
- is a medicine within the meaning of the Act;
- contains a substance mentioned in Schedule 4 or 8 to the Poisons Standard; and
- is normally available for supply in Australia.
Prescription medicines require an authorised health professional's written instruction (prescription) before they can be obtained from a registered pharmacist. The types of therapeutic goods that are regulated as prescription medicines are listed in Part 1 of Schedule 10 of the Therapeutic Goods Regulations 1990.
In relation to therapeutic goods means: The way in which therapeutic goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.
Action to eliminate the cause of a potential deficiency or nonconformity (based on ISO 9000 Clause 3.12.1). There can be more than one cause for a potential deficiency or nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
Is the outcome variable that is designated as the key in the design or analysis of the trial results.
The complete pack in which the goods, or the goods and their container, are to be supplied to consumers
The manufacturer who manufactures the goods or who performs one or more steps in the manufacture of the goods and also contracts with, or controls the use of other sub-manufacturers for the performance of the remaining steps in manufacture of the goods
Small proteinaceous infectious particles that resist inactivation by procedures that modify nucleic acids. Some prions can cause transmissible spongiform encephalopathies.
Report of a suspected deficiency of quality, safety or efficacy in a therapeutic good.
The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
In relation to biologicals, means any activity involved in the preparation, manipulation, preservation for storage and packaging of a biological
The commercial presentation or marketed entity of therapeutic goods.
Product defect alert
a type of recall action that raises awareness of concerns about safety, quality, efficacy or performance when discontinuation of treatment is considered riskier than continued use of the deficient product
Product defect correction
a type of recall action undertaken to correct a specific or potential deficiency. In some instances, the product can continue to be used if there is robust mitigation in place until a permanent correction has been implemented
Product Information (PI)
Product information is defined in s3 of the Therapeutic Goods Act 1989 to mean:
'in relation to therapeutic goods, information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods'.
This term is used in ARTG application forms and guides when asking for copies of information provided about the goods for medical practitioners and/or patients/users. It includes Consumer Medicine Information (CMI), Product Information (PI) and promotional material.
Product name - medicines
The proprietary name as shown on the label or where there is no proprietary name, the registration/listing name.
a type of non-recall action that involves the issuing of information about a therapeutic good, in a situation that is unlikely to involve significant adverse health consequences
Reference number assigned by ARTG to each product grouped under one registration or listing.
a type of non-recall action that involves a sponsor's removal from supply or use of therapeutic goods for reasons not related to their quality, safety or efficacy
Professional supervision of manufacture
In relation to autologous human cells and tissues products, professional supervision of manufacture means that the medical or dental practitioner with primary responsibility for the clinical care of a patient is party to all manufacturing steps that are performed in a formal governance arrangement with the person or persons undertaking the manufacturing. This would include input into the protocols and quality systems used in the manufacturing process.
A representation referred to in subsection 42DJ(1) of the Act
A formulation usually containing two or more ingredients for which some information is not in the public domain. Proprietary ingredients include, for example, fragrances, flavours, colouring ingredients, adhesives and printing inks.
Means the registered trademark of the therapeutic goods or the unique name assigned to the goods by the sponsor and appearing on a label.
Proprietary research is commissioned research (e.g. clinical trials sponsored by a drug company) undertaken on the basis that the proposal, data and results will remain confidential for a specified length of time. Some companies conduct their own proprietary research; others request and fund research by academic and other research institutions.
All clinical trials are based on a protocol, which describes who may participate in a trial, the length of a trial and the schedule of tests, procedures, medications and dosages.
Pharmaceutical Subcommittee (of ACPM)
Quality Management System - a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organisation.
Quality Risk Management - A systematic process for the assessment, control, communication and review of risk to the quality of medicinal products.
Quantitative structure activity relationships
In relation to impurities in drug substances, the process of acquiring and evaluating data that establish the biological safety of an individual impurity or a given impurity profile at the level(s) specified.
In relation to impurities in drug substances, a limit above which a degradation product should be qualified
In relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction, and performance characteristics of the goods.
In relation to non-recall actions: a type of non-recall action in which the sponsor suspends further supply pending investigation of an issue or incident. The outcome of the investigation will determine further actions. A recall may occur after quarantine.
In relation to biologicals: the isolation, physically or by other effective means, of starting or packaging materials, intermediate, bulk or finished products while awaiting a decision on their release or refusal.
Radiopharmaceutical products comprise:
- ready-for-use radiopharmaceuticals, including positron emission tomography (PET) radiopharmaceuticals;
- nonradioactive components (kits and chemical precursors, including those for PET) for combination with a radioactive component (e.g. eluate from a radionuclide generator or a cyclotron-produced radionuclide);
- radionuclide generators;
- radionuclide precursors used for radiolabelling other substances before administration.
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
Randomised controlled trial (RCT)
An experiment in which investigators randomly allocate eligible people into intervention groups to receive or not to receive one or more interventions that are being compared. The results are assessed by comparing outcomes in the treatment and control groups.
Refers to one or more of the following activities carried out on single use devices to supply for reuse:
- Assembly the device; or
- Packaging the device; or
- Processing the device; or
- Fully refurbishing the device; or
- Labelling the device; or
- Assigning the device a new intended purpose by means of information supplied by on or in the labelling; the instructions for use or advertising material
In the process, the person responsible for undertaking these activities on a single use device has:
- Changed the intended purpose of the device;
- Certified the device is suitable for reuse; and
- Assumed the legal liability for the quality, safety and performance of the device
a type of recall action, in which therapeutic goods are permanently removed from the market or from use when there are deficiencies or potential deficiencies in the safety, quality, efficacy, performance or presentation
A recall action occurs when there are deficiencies or potential deficiencies in the safety, quality, efficacy, performance or presentation of therapeutic goods. There are four types of recall action:
- product defect correction
- hazard alert
- product defect alert.
Recurring deficiency or nonconformity
Deficiency or nonconformity that was also identified at a previous inspection, for which the corrective and preventive actions taken earlier were ineffective.
Is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device
Refurbishment of a medical device may involve the following actions:
- stripping the device into component parts or sub assemblies
- checking parts of the device for suitability for reuse
- replacing component parts or sub assemblies of the device that are not suitable for reuse
- assembling reclaimed or replacement component parts or sub assemblies of the device or another used device
- testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications
- identifying an assembled device as a refurbished device
Therapeutic goods included in the part of the ARTG for goods known as registered goods; or therapeutic goods included in the part of the ARTG for goods known as provisionally registered goods.
Goods that are required by the Act to be included in that part of the ARTG for Registered goods or for provisionally registered goods.
See AUST R number
Registration/listing name - medicines
The name which will appear on the Certificate of Registration/Listing. The Registration/ Listing name is a fully descriptive name which enables clear identification of the goods as they are presented for supply. Where goods have a name which applies to more than one product, the name must be followed by sufficient details to enable unique identification. It includes: the proprietary name (if any); and the non proprietary name; or a descriptive name which includes a commercial identifier such as sponsor name; and must include the dosage form, and where appropriate, the strength and container type.
The Therapeutic Goods Regulations 1990.
In relation to eCTD, the term Regulatory Activity is a subgroup of an Application which can be a group of related sequences for one approval or notification process (e.g. one variation). One Regulatory Activity is usually defined for the lifecycle of the specific approval process.
In relation to impurities in drug substances, an organic impurity sharing structural features with the drug substance formed either during the synthesis of the drug substance ('synthetic impurities') or during storage ('degradants'), excluding impurities derived from catalysts, solvents and reagents.
- In relation to the analysis of therapeutic goods (other than medical devices), means a test that, under sub regulation 28 (1), is a relevant test to determine whether the goods conform with an applicable standard applicable to the goods; and
- in relation to the analysis of a medical device, means a test that, under sub regulation 28 (2), is a relevant test to determine whether a medical device complies with the applicable provisions of the essential principles.
Tissue concerned with or relating to reproduction
In relation to a medicine that has been the subject of an anticipated or current shortage, means:
- in relation to a medicine which has been the subject of an anticipated shortage - a shortage is no longer anticipated to commence in the future other than by reason that there is a current shortage of the medicine; and
- in relation to a medicine which has been the subject of a current shortage – that the supply of the medicine is now meeting normal consumer demand.
In relation to the analysis of a sample of therapeutic goods, means an official analyst who is nominated as a responsible analyst for the sample under paragraph 25 (3) (c) of the Therapeutic Goods Regulations.
A restricted representation is a reference, expressly or by implication, to a serious form of a disease, condition, ailment or defect. Serious, in the context of the Therapeutic Goods Advertising Code (No.2) 2018, means forms of diseases, conditions, ailments or defects where:
- it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or
- there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up.
(also see Restricted representations)
Validation of a process for a product which has been marketed, based upon a review of accumulated manufacturing, testing and batch data.
A device designed or intended by the manufacturer as suitable for reprocessing and reuse. It is not a device that is designed or intended by the manufacturer for single use only.
The repeated use or multiple use of any medical device which has undergone some form of reprocessing (cleaning, disinfection or sterilisation) between each episode of use
A decision of the Minister under section 60(3) of the Act. Subject to paragraph 60A(2)(b) of the Act, the Minister must, as soon as practicable after receiving a request under subsection (2), reconsider the initial decision and, as a result of that reconsideration, may:
- confirm the initial decision; or
- revoke the initial decision, or revoke that decision and make a decision in substitution for the initial decision.
Release for further processing - a release step in the manufacture of medicinal products prior to the final release for supply step.
Release for Supply - release of finished product for supply.
Risk management plan
Route of administration
Route by which a therapeutic good is applied on or introduced into the body
a type of non-recall action issued by sponsors that consists of advice on the safe use of therapeutic goods in certain situations where, although meeting all specifications and therapeutic indications, its use could present an unreasonable risk of harm if certain specified precautions in regard to its use are not followed
Safety related request
A safety-related request to vary an entry in the Australian Register of Therapeutic Goods is one where the variation has one of two possible outcomes:
- to reduce the patient population (e.g. remove an indication or limit the use of the medicine); or
- to have the effect of adding a warning or precaution (e.g. an adverse effect or interaction).
Safety-related requests are made under s. 9D(2) of the Therapeutic Goods Act 1989.
Sterility assurance level
An officer of the Department performing duties under the direction of an official analyst. As defined in Regulation 23 of the Therapeutic Goods Regulations.
Self assessable notification
Schedule 10 medicines
A medicinal product of a type described in Schedule 10 of the Therapeutic Goods Regulations. Medicines in Part 1 of Schedule 10 are evaluated by the Drug Safety and Evaluation Branch of TGA.
Is the less clinically important when compared to the primary study outcome.
Means the Secretary of the Department of Health
Indicates whether the diagnosed condition is beyond the ability of the average consumer to evaluate accurately and manage safely without the supervision by and assistance from a suitably qualified health care professional.
A formulation that does not require addition of a preservative(s) to meet the preservative efficacy criteria.
A device is one that comes into contact with intact mucous membranes or broken skin. The device should be sterilised where possible, or high-level disinfected.
Semisynthetic drug substance
A substance in which the structural constituents have been introduced by a combination of chemical synthesis and elements of biological origin (e.g. obtained from fermentation or by extraction from botanical material).
Separate and distinct goods
A therapeutic good is taken to be separate and distinct from other therapeutic goods if it has:
- a different formulation, composition or design specification; or
- a different strength or size (disregarding pack size); or
- a different dosage form or model; or
- a different name; or
- different indications (except for variations to indications under s. 9D(2) of the Therapeutic Goods Act 1989, as described in s. 9D(2A).); or
- different directions for use; or
- a different type of container (disregarding container size).
In relation to eCTD, a sequence is a package of information bundled together in an electronic structure providing information to the agency. The contents of a sequence will depend on the regulatory activity type and whether it is the initial sequence of the regulatory activity or a follow-up providing additional data or changes.
A serialised medicine is one where each unit bears a unique identifier, allowing the unit to be identified distinctly within its batch. This typically is achieved through a serial number applied to the unit. A definition of serialisation is provided in Section 4 of TGO 106.
See Guidelines on the reporting of adverse drug reactions by drug sponsors: Definitions
Seriously debilitating condition
A condition that has as a prominent feature (i.e. affecting an important portion of the target population) which is morbidity with a well-established, major impact on the functioning of the person based on objective and quantifiable medical or epidemiologic information. Short-lived and/or self-limiting morbidity is not considered seriously debilitating.
Therapeutic goods which are required in the public interest but whose supply does not offer financial incentive for the sponsor.
The time period during which a therapeutic good is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.
In relation to a medicine, means that the supply of the medicine is not reasonably likely to meet the normal or projected consumer demand for the medicine within Australia for a period of time.
Any objective evidence of a disease, that is, such evidence as is perceptible to the examining physician, as opposed to the subjective sensations (symptoms) of the patient.
Strategic Information Management Environment - now called TGA eBusiness services
Similar Biological Medicinal Product (SBMP)
Similar biological medicinal product may be used interchangeably with biosimilar.
A clinical trial where the participants are unaware of the whether they are receiving the placebo or active medicine or treatment.
Single patient use
More than one episode of use of a medical device on one patient only, the device may undergo some form of reprocessing between each use in accordance with the manufacturers instructions for reuse on the same patient
Single step of manufacture
For the purpose of annual licence charge classification only - for example one of the following: tablet coating; capsule filling from bulk; aerosol filling from bulk; storage other than for sale; packaging including labelling; sterilisation; testing including analysis; assembling devices from components, testing or batch testing of therapeutic devices; releasing for sale (by a person not involved with actually preparing the goods).
Means the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient. Some single-use devices are marketed as non-sterile which require processing to make them sterile and ready for use. The manufacturer of the device will include appropriate processing instructions to make it ready for use
This refers to the place where a clinical trial is conducted. When a clinical trial is conducted at more than one site, but using the same protocol, it is referred to as a multi-site or multi-centre trial.
Identification code assigned by the Manufacturer Assessment Section (MAS) to a manufacturing site(s) for an enterprise which is involved with the manufacture of therapeutic goods.
The outer integument, or covering, of the body — consisting of the dermis and the epidermis and resting upon the subcutaneous tissues
Software as a Medical Device (SaMD)
software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
- SaMD is a medical device itself and includes in-vitro diagnostic (IVD) medical devices. It is capable of running on general purpose (non-medical purpose) computing platforms. The term ‘without being part of’ means software not necessary for a hardware medical device to achieve its intended medical purpose.
- Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
- SaMD may be used in combination (e.g., as a module) with other products including medical devices. SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software.
- Mobile apps that meet the definition above are considered SaMD.
Software Bill of Materials
A list of software components used within a medical device, including third-party software, software of unknown provenance (SOUP) and version numbers where applicable.
Summary of product characteristics
In relation to an advertisement or generic information, means:
- mainstream media within the meaning of Section 42B of the Act OR
- cinematograph films OR
displays about goods, including posters
- in shopping malls (except inside an individual shop)
- in or on public transport
- on billboards
An indicator microorganism that is identified in TGO 100 and in the default standards (i.e. Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella, bile-tolerant gram-negative bacteria and Candida albicans).
In relation to biologicals, a microorganism that, if isolated from the tissue, requires the tissue to be discarded.
In relation to therapeutic goods, means:
- a person who exports, or arranges the exportation of, the goods from Australia; or
- a person who imports, or arranges the importation of, the goods into Australia; or
- a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);
but does not include a person who:
- exports, imports or manufactures the goods; or
- arranges the exportation, importation or manufacture of the goods;
on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.
In relation to a medicine, means the person in relation to whom the medicine is included in the ARTG.
In relation to the recall of therapeutic goods, the sponsor also includes the person to whom the goods are on, or cancelled or suspended from the ARTG; or supplying exempt goods; or illegally supplying goods or manufacturing goods.
See Section 3(1) of the Therapeutic Goods Act 1989. Must be specified in a TGO or the BP. A general standard that applies to all products of a particular dosage form. A specific standard of medicines refers to a particular dosage form of particular active ingredient(s).
In relation to a medicinal product, any substance (active or excipient) used in the production of a medicinal product, excluding packaging materials.
A law of a State, of the Australian Capital Territory, or of the Northern Territory.
The probability that an event or difference is real or occurred by chance alone. It does not indicate whether the difference is small or large, important or trivial. The level of statistical significance depends on the number of patients studied or observations made, as well as the magnitude of difference observed. Statistical significance observed in a clinical trial does not necessarily imply clinical significance.
Step in manufacture
Any part of the process of bringing goods to their final state which may be completed separately from other parts of the process.
The quantity of an active pharmaceutical ingredient in a medicine or a formulated or medicated device.
A manufacturer who completes part of the manufacturing process of therapeutic goods on behalf of the principal manufacturer (no longer used in the ARTG system - replaced by manufacturer with an identified step in manufacture).
Subject / trial subject
An individual who participates in a clinical trial, either as a recipient of the medicine or treatment, or as a control.
A series of related applications made under the Therapeutic Goods Act on the same day for the same active ingredient, lodged by the same sponsor.
In relation to eCTD, this is a generic term that can refer to an application, a regulatory activity type and/or a sequence. Often used when not referring specifically to a particular hierarchical level of the application.
In relation to a medicine which is subject to a shortage, means a medicine that has the same active ingredient as the medicine subject to the shortage, but may have a different strength, dosage form or route of administration.
Summary of product characteristics (SmPC)
European equivalent to the Australian product information (PI).
In general: a person or organisation that is involved in the supply and distribution of the product, but not involved in product manufacture.
In relation to the manufacture of a medicinal product: any entity supplying the starting and/or packaging material to the manufacturer of a medicinal product. This entity should normally be the actual manufacturer of the starting or packaging material, rather than a broker or agent.
The process of establishing confidence in the reliability of the supplier to consistently provide material of acceptable quality.
The approved entity supplying starting and/or packaging material to the manufacturer of a medicinal product. This entity should normally be the actual manufacturer of the starting or packaging material, rather than a broker or agent. However brokers or agents may be additionally approved if they play significant roles in the supply chain other than merely on-selling the starting or packaging materials.
An approved supplier, supplying the starting and/or packaging material to the manufacturer of medicinal products, who has undergone the process of supplier qualification. The supplier should normally be the actual manufacturer of the starting or packaging material, not a broker or agent.
- by way of sale, exchange, gift, lease, loan, hire or hire purchase; and
- whether free of charge or otherwise, by way of sample or advertisement; and
- whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons; and
- by way of administration to, or application in the treatment of, a person.
In relation to a medicine, means the overall arrangements for the meeting of consumer demand.
A surrogate endpoint (or marker) is a measure of effect of a certain treatment that may correlate with a real clinical endpoint but doesn't necessarily have a guaranteed relationship. The National Institutes of Health (USA) define surrogate endpoint as "a biomarker intended to substitute for a clinical endpoint".
Standard for the Uniform Scheduling of Drugs and Poisons (replaced in 2010 by the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP))
Standard for the Uniform Scheduling of Medicines and Poisons (also known as the Poisons Standard)
Any subjective evidence of disease or of a patient's condition, that is, such evidence as perceived by the patient.
A set of symptoms which occur together; a symptom complex.
The central code of an operating system, managing the core operation of the computer and hardware, most critically computer memory and the central processing unit (CPU).
An analysis of a large number of clinical trials (sometimes known as a 'meta-analysis') aimed at looking for an overall pattern in the trial results. Cochrane Reviews are examples of such systematic reviews. In a systematic analysis only those trials which meet a number of pre-set conditions in relation to research design (e.g. sample size, randomisation) are included in the final meta-analysis.
Systems [regulated devices]
Therapeutic goods are tampered with if:
- they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and
- the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.
Therapeutic Goods Administration, which is part of the Department of Health.
TGA Approved Terminology for Medicines
A compendium document which (in the main) identifies terms to be used when making an application to the TGA for registration of medicines.
In relation to a medicine which is subject to a shortage, means other therapeutic options that a health professional may consider as an alternative treatment for a patient who may be affected by a shortage of the medicine.
that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
- for therapeutic use; or
- for use as an ingredient or component in the manufacture of therapeutic goods; or
- for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
- included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);
and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:
- goods declared not to be therapeutic goods under an order in force under section 7; or
- goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or
- goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991); or
- goods (other than goods declared to be therapeutic goods under an order in force under section 7) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.
Therapeutic Goods Advertising Code (TGAC)
Therapeutic goods information
Means information in relation to therapeutic goods that is held by the Department and relates to the performance of the Department's functions (including functions relating to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement).
Therapeutic Goods Order (TGO)
An Australian standard that relates to a particular type of therapeutic good, or specifies particular requirements for labelling, packaging or other aspects.
In relation to cyber security: any circumstance or event with the potential to adversely impact the device, organisational operations (including mission, functions, or reputation), organisational assets, individuals, or other organisations through an information system via unauthorised access, destruction, disclosure, modification of information, and/or denial of service. Threats exercise vulnerabilities, which may impact the safety or essential performance of the device.
TGA-Industry Consultative Committee
Any constituent part of the body formed by cells
Applied to a certain area of the skin for a localised effect
For therapeutic goods of a particular kind, means the commercial name:
- given to goods of that kind by the manufacturer; and
- under which the goods are supplied. See Regulation 2 of the Therapeutic Goods Regulations 1990.
Means a trading corporation within the meaning of paragraph 51(xx) of the Constitution.
Use of a designated active ingredient that is well-documented, or otherwise established, according to the accumulated experience of many traditional healthcare practitioners over an extended period; and accords with well-established procedures of preparation, application and dosage
Applied to the skin for a systemic effect by the diffusion or continuous absorption of the active ingredient through the skin
Lists the impurities controlled by that monograph by name and/or chemical structure.
Threshold of toxicological concern
Technical Working Groups [manufacturing]
In relation to impurities in drug substances and drug products means:
An impurity for which structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g. chromatographic retention time), as defined in Note for guidance on impurities testing: impurities in new drug substances ICHQ3A(R) (CPMP/ICH/2737/99)
In relation to impurities in drug substances are impurities other than related impurities.
United States of America
Universal serial bus
For medical devices that are supplied sterile:
- the device has been placed into a wound or body cavity and comes into contact with blood or body fluids; or
- has been opened but cannot be reprocessed because the manufacturer did not provide instructions on how to reprocess the device if the package is opened or damaged.
For medical devices that are supplied non-sterile:
- the device has been applied for its intended purpose.
United States Pharmacopoeia
United States Pharmacopeia-National Formulary
A change to an Australian Register of Therapeutic Goods entry.
Pertaining to viruses
Vital physiological process
Of a patient, means a process that is necessary to sustain life and the indicators of which may include any 1 or more of the following:
- heart rate
- cerebral function
- blood gases
- blood pressure
- body temperature
Validation Master Plan - a document which clearly defines the key elements of a validation program to achieve and maintain a qualified facility and associated systems.
In relation to cyber security: a weakness in an information system, system security procedures, internal controls, human behaviour, or implementation that could be exploited by a threat.
World Wide Web Consortium - international standards organisation for the world wide web.
Warning or precaution
One or more statements in the product information (PI) that draw attention to potential adverse effects resulting from product use.
The stage in a cross-over trial where treatment is withdrawn before a second treatment is given. This is usually necessary to counteract the possibility that the first substance can continue to affect the subject for some time after it is withdrawn.
Working Cell Bank
White hat hackers
In relation to cyber security: groups or individuals, including security researchers and professionals, who assess a target system to find (deliberately or inadvertently) its vulnerabilities (known or new) and who may implement 'exploits' to test these vulnerabilities, reporting their findings following ethical rules.
World Health Organization
For the evaluation of applications, means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory; Otherwise means any day except: (a) Saturday or Sunday; or (b) a day that is a public holiday in the State or Territory in which the person is located.
Refers to any procedure involving the delivery into a human patient of:
- live animal cells, tissues or organs
- human body fluids, cells, tissues or organs that have had contact with live animal cells or tissues outside the patient's body