A-Z guide
A
- Adverse drug reactions
- Adverse drug reactions bulletin
- Advertising therapeutic products
- Alcohol wipes/swabs (regulation of)
- Alerts & advisory statements
- Analgesics - alerts & advisories
- Analytical procedure validation for complementary medicines
- Annual reports
- Antibacterial hand washes
- ANZTPA (Australia New Zealand Therapeutic Products Authority)
- Application for advertising approval
- Application for selective non-disclosure of active herbal extract details
- Application to request approval to export human blood, tissue and related materials
- Approved terminology for medicines
- Aristolochia - alerts & advisories
- Aspirin: See Analgesics - alerts & advisories
- Audit of medicine manufacturers
- Australia - European Community mutual recognition agreement (EC-MRA)
- Australia New Zealand Therapeutic Products Authority (ANZTPA)
- Australian Adverse Drug Reactions Bulletin
- Australian approved manufacturers
- Australian approved names: Approved terminology for medicines
- Australian clinical trial handbook
- Australian code of good manufacturing practice - human blood and tissues
- Australian code of good manufacturing practice for medicinal products
- Australian code of GMP for therapeutic goods - sunscreen products
- Australian code of good wholesaling practice for therapeutic goods for human use
- Australian Drug Evaluation Committee (ADEC)
- Australian manufacturers licensed to manufacture therapeutic goods
- Australian Public Assessment Report (AusPAR) for prescription medicines
- Australian register of therapeutic goods (ARTG)
- Australian regulatory guidelines for complementary medicines (ARGCM)
- Australian regulatory guidelines for OTC medicines (ARGOM)
- Australian regulatory guidelines for prescription medicines (ARGPM)
- Australian Therapeutic Device Bulletin
- Authorised prescriber scheme
- Ayurvedic medicines
B
- Biological therapies
- Black cohosh (Cimicifuga racemosa)
- Blood & tissues regulation
- BotanicLab alert (Arthrin, Osporo, Poena, Neutralis, 5OA Plus, RA Spes and Hepastat)
- "Boundary" products (medical device/medicine)
- Breast implant information booklet
- Bupropion (Zyban SR)
- Business plans
- Buying medicines - What's on the label for me?
C
- Cancellation & suspension of a medical device entry in the Australian Register of Therapeutic Goods (ARTG)
- Cerivastatin (withdrawal from sale)
- Certificate of Listed Product (CLP)/Certificate of Pharmaceutical Product (CPP)
- Class 1 medical devices
- Clexane: Heparin products
- Client details form
- Clinical trials
- Codex Alimentarius Commission
- Colourings permitted in medicines for oral use
- Common technical document (CTD)
- Complementary medicines in the Australian health system - Report to the Parliamentary Secretary to the Minister for Health and Ageing
- Complementary medicines regulation in Australia - an overview
- Compositional guidelines
- Condoms (regulation of)
- Conformity assessment bodies (CABs) approved to undertake assessments to Australian requirements (EC-MRA)
- Conformity assessment standards orders
- Consumer Medicines Information (CMI)
- Controlled substances (import/export)
- Corporate plans
- Cosmetics
- Cost recovery impact statements
- CPMP/ICH/135/95 Note for guidance on good clinical practice
- CPMP/ICH/377/95 Note for guidance on clinical safety data management: definitions and standards for expedited reporting
- Customer service charter
D
- Default standards
- Definitions - medicines
- Dental products - regulation of
- Diethylstilboestrol (DES)
- Device Electronic Application Lodgement (DEAL)
- Disinfectants & sterilants
- Dr Rohan Hammett - TGA's National Manager
- DR4
E
- eBusiness Services website
- EC certificates for medical devices (manufacturers' evidence)
- Electronic funds transfer agreement
- Electronic Listing Facility (ELF)
- Email lists (subscribe/unsubscribe)
- Emerging biological therapies
- Employment
- Enforcement/offences/illegal supply of medical devices
- Essential principles (medical devices)
- European Union guidelines
- Events & training
- Excluded goods orders
- Expert Committee on Complementary Medicines in the Health System (ECCMHS)
- Exporting/importing
F
- Fees & payments
- Fit and proper persons requirements
- Folic acid
- Food or therapeutic good? - Section 7 declarations
- Forms
- Application for a licence to manufacture therapeutic goods
- Application for advertising approval
- Application for an evaluation of a new complementary medicine substance
- Application for declaration that turnover is of low volume and low value
- Application for registration (including Pharmaceutical Benefits Listing) of prescription medicines / to vary the conditions of registration of prescription medicines
- Application for selective non-disclosure of active herbal extract details
- Application to request approval to export human blood, tissue and related materials
- Authorisation to cancel a product from the Australian Register of Therapeutic Goods
- Authorised prescriber - Agreement to treatment directions
- Authorised prescriber - Consent to treatment and indemnity for use of products derived from biological tissues including human blood or plasma
- Client details form
- Clinical trial forms
- Electronic funds transfer agreement
- Facility registration - human cells, tissues, cell and tissue-based products
- GMP audit of overseas manufacturer application form
- Human blood & tissues recall report form
- Justification for a particular route of evaluation
- Medical devices directive checklist (EC-MRA)
- Medical devices essential principles checklist
- Medicine problem report form
- New medicine registration application form (complementary medicines)
- Nomination form for electronic billing
- Notification of a proprietary ingredient
- Pre-submission planning form (prescription medicines)
- Registered medicine variation form (complementary medicines)
- Report of suspected adverse reaction to medicines/vaccines ("blue card")
- Report of the manufacture of exempt therapeutic goods
- Reporting problems with medical devices
- Request form for GMP or Quality Systems certificates
- Special access scheme forms
- Supply of information for the creation of a Provisional ARTG Record (PAR)
- TGA credit card authorisation form
G
- Galbally review (review of drugs, poisons and controlled substances legislation)
- Gardasil
- Gel packs (safety advisories)
- Global Harmonization Task Force (GHTF)
- GMDN codes and the Australian regulatory system
- Greater celandine (Chelidonium majus)
- Green lipped mussel and cancer
- Groups orders
- Guidant pacemakers (advice to physicians)
- Guide to interpretation of the Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) applicable to the manufacture of complementary medicines
- Guidelines for levels and kinds of evidence to support indications and claims
- Guidelines on the GMP clearance of overseas medicine manufacturers
- Guidelines on the reporting of adverse drug reactions by drug sponsors
H
- H1N1 2009 influenza vaccine
- Haematopoietic progenitor cells (HPCs): Blood & tissues
- Hammett: Dr Rohan Hammett - TGA National Manager
- HCT: Human cellular and tissue therapies
- Head lice preparations
- Heparin products
- Homoeopathic meningococcal "vaccines"
- Homoeopathic preparations
- Hormone replacement therapy (HRT)
- Hot/cold gel packs (safety advisories)
- Human blood & tissues recall report form
- Human papillomavirus vaccine (Gardasil)
- Human research ethics committees and the therapeutic goods legislation
- Human tissues & emerging biological therapies
- Hydroxycitrate complex
- Hypericum perforatum (St John's wort)
I-J-K
- Identification of herbal materials and extracts
- Illegal supply of medical devices
- Importing/exporting
- Incident Report Investigation Scheme (IRIS)
- In vitro diagnostic devices (IVDs) (regulation of)
- IVF solutions: Information to be provided to support an application for in vitro fertilisation (IVF) solutions in Australia
- Influenza vaccine: AIVC recommendations for the composition of influenza vaccine
- Ingredients (regulation of complementary medicines)
- International agreements
- International training
- IRIS (Incident Report Investigation Scheme)
- Jobs (employment)
- Kava - alerts & advisories
L
- Labelling of medicines
- Laboratory information bulletin
- Legislation
- Listed medicines - see: Complementary medicines
- Listing notices
- Literature-based submissions - points to consider
- Lumiracoxib (Prexige)
M
- Manufacturers' evidence - EC certificates for medical devices
- Manufacturer's Information System (MIS)
- Manufacturing principles
- Media releases & statements
- Medical devices notices (legislative instruments)
- Medical device recalls
- Medical devices alerts & advisories
- Medical Device Evaluation Committee (MDEC)
- Medical devices directive checklist (EC-MRA)
- Medical devices essential principles checklist
- Medical Device Incident Report Investigation Scheme (IRIS)
- Medical devices regulatory guidelines
- Medical devices standards orders
- Medical Officer vacancies at the TGA
- Medical products and the Internet: A guide to finding reliable information
- Medicine alerts & advisories
- Medicine problem report form
- Medicine recalls
- Medicines definitions
- Medicines Evaluation Committee (MEC)
- Medicines information kit
- Medicines labelling
- Medicines regulation and the TGA
- Medicines Safety Update
- Meningococcal "vaccines" (homoeopathic)
- Menstrual cups (regulation of)
N
- Nanotechnology & therapeutic products
- National Co-ordinating Committee on Therapeutic Goods (NCCTG)
- National Drugs and Poisons Schedule Committee (NDPSC)
- NCCTG IVD working group
- NDPSC guide to labelling drugs and poisons
- NDPSC guide to the packaging, labelling and regulation of paints, tinters and related products
- Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95)
- Note for guidance on good clinical practice (CPMP/ICH/135/95)
O
- Offences/enforcement/illegal supply of medical devices
- Office of Complementary Medicines (OCM)
- Online services: eBusiness Services website
- OPAL (OTC medicines electronic lodgement system)
- Orphan drugs
P-Q
- Pandemic (H1N1) 2009 influenza vaccine
- Panvax® H1N1 vaccine: Report an adverse reaction to the pandemic (H1N1) 2009 influenza vaccine
- Paracetamol - alerts & advisories
- Personal importation of therapeutic goods
- Phenylephrine - Registration of products containing phenylephrine in place of pseudoephedrine
- Peripherally inserted central catheters (PICC lines) - safety alerts & advisories
- Phenylpropanolamine
- PIC/S explanatory notes for industry on the preparation of a site master file
- Potassium chloride - media release re scheduling
- Prescribing medicines in pregnancy - An Australian categorisation of risk of drug use in pregnancy
- Pre-submission planning form (prescription medicines)
- Prexige (Lumiracoxib)
- Product discontinuations - Guideline on product discontinuations
- Product Information (PI)
- Product recalls
- Prohibited & controlled substances (import/export)
- Pseudoephedrine rescheduling - information for sponsors
- Quantified by input
R
- Recalls
- Recruitment
- Regulation of complementary medicines in Australia - an overview
- Regulation of therapeutic goods in Australia
- Regulatory affairs consultants
- Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
- Report of a review of advertising therapeutic products in Australia and New Zealand (November 2002)
- Report to Health Ministers on a cost-benefit analysis of pharmacist only (S3) and pharmacy medicines (S2) and risk-based evaluation of the standards
- Reporting problems with medical devices
- Required advisory statements for medicine labels
- Reusable medical devices
- Review of drugs, poisons and controlled substances legislation (the Galbally Review)
- Review of the need for further regulation of extemporaneous compounding
- Review of the Therapeutic Goods Administration's consultative arrangements (July 2004)
- Reye's syndrome - Review of Aspirin / Reye's syndrome warning statement (April 2004)
- Risk management - TGA's risk management approach
S
- SAMe ((S)-S-adenosylmethionine)
- Section 7 declarations - food or therapeutic good?
- SIME: eBusiness Services website
- Single use devices
- Site master files - PIC/S explanatory notes for industry on the preparation of a site master file
- Special access scheme
- Sporting teams visiting Australia - bringing medicines into Australia
- SSRI antidepressants - alerts & advisories
- St Johns wort - alerts & advisories
- Stability testing of Listed complementary medicines
- Standard for the uniform scheduling of drugs and poisons (SUSDP)
- Stem cells: TGA report on information and advertising associated with products tested, created or manufactured using human embryos or human embryonic stem cells
- Sterilants & disinfectants
- Sterility testing: TGA guidelines for sterility testing of therapeutic goods
- Stilnox
- Substances that may be used in Listed medicines in Australia
- Summary classfication of medicines
- Sunscreens
- Suspension & cancellation of a medical device entry in the Australian Register of Therapeutic Goods (ARTG)
- Swine flu vaccine
- Report an adverse reaction to the pandemic (H1N1) 2009 influenza vaccine
T
- Tamper-evident packaging
- Tampons (regulation of)
- Technical working groups (TWGs)
- TGA approved terminology for medicines
- TGA business plans
- TGA customer service charter
- TGA guidelines for sterility testing of therapeutic goods
- TGA Laboratories
- TGA Laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use
- TGA News
- TGA report on information and advertising associated with products tested, created or manufactured using human embryos or human embryonic stem cells
- TGA's risk management approach
- TGA-UPDATE email list (subscribe/unsubscribe)
- Therapeutic Device Evaluation Committee (TDEC) - also see: Medical Device Evaluation Committee (MDEC)
- Therapeutic Goods Act 1989 (ComLaw website)
- Therapeutic Goods Advertising Code
- Therapeutic Goods Advertising Code Council (TGACC)
- Therapeutic Goods Committee (TGC)
- Therapeutic Goods (Charges) Act 1989 (ComLaw website)
- Therapeutic Goods (Charges) Regulations 1990 (ComLaw website)
- Therapeutic Goods (Goods that are not Therapeutic Devices) Order No. 1 of 1992
- Therapeutic Goods (Groups) Order No. 1 of 2001
- Therapeutic Goods (Groups) Order No. 1 of 1992
- Therapeutic Goods (Listing) Notices
- Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007
- Therapeutic Goods (Medical Devices) Regulations 2002 (ComLaw website)
- Therapeutic Goods Orders (TGOs)
- Therapeutic Goods Regulations 1990 (ComLaw website)
- Therapeutic goods regulatory affairs consultants
- Tissues - regulation of
- Training & events
- Transmissible spongiform encephalopathies (TSEs)
- Travellers entering or leaving Australia
U
V-W-X-Y-Z
- Vaccines: AIVC recommendations for the composition of influenza vaccine
- Wholesaling practice: Revision of the Australian code of good Wholesaling practice for therapeutic goods for human use
- World Health Organization collaborating centres
- Zirconia femoral head hip prostheses
- Zolpidem (Stilnox)
- Zyban (Bupropion