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Australian prescription medicine decision summaries
Before a prescription medicine can be made available in Australia, the company legally responsible for supplying the product must lodge a submission with the Therapeutic Goods Administration (TGA). The TGA evaluates the submission for safety, quality and effectiveness of the product before the registration of the prescription medicine in the Australian Register of Therapeutic Goods.
The Australian Prescription Medicine Decision Summary (AusPMDS) provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG). Publishing AusPMDS is an important part of transparency of the TGA's decision-making processes.
We publish an AusPMDS for new chemical, biological and biosimilar prescription medicines included in the ARTG from 1 September 2019. The first AusPMDS was published on 10 September 2019.
An AusPMDS is a static document that is submission specific. It is not intended to be updated to reflect variations to a prescription medicine after its first ARTG entry.
Structure of a AusPMDS
The AusPMDS is a brief document largely in a question and answer format, with information contained under drop-down headings.
An AusPMDS has three main parts:
- Submission details
Details of the product including ingredients, pack size, dosage, person in relation to whom the medicine is registered (‘the sponsor'), pregnancy category, etc
- Questions and Answers
- What was approved? The indication(s) or use(s) the medicine is approved for.
- What is this medicine and how does it work? Describes the medicine and how it works in humans.
- What was the decision based on? The types of data that the TGA evaluated.
- What steps were involved in the decision process? Details and dates of the key steps and milestones in the TGA's decision process.
- What post-market commitments will the sponsor undertake? Specific commitments that the sponsor will undertake after the approval. These commitments are imposed as conditions of registration with which the sponsor must comply.
- Further details
Links to other relevant information on the TGA website.
Source of content for AusPMDS
The main content of an AusPMDS is sourced from the:
- public ARTG entry
- approval letter (noting references to conditions of registration may be summarised, shortened or omitted)
- PI approved for the medicine.
Other information about the type of evaluations and registration timeline is also included.
The approved Product Information (PI) can be found on the TGA website.
|Summary of submission||The ARTG entry and approved PI.|
|What was approved?||Approved indications from the ARTG entry.|
|What is this medicine and how does it work?||The TGA approved PI.|
|What was the decision based on?||Lists the types of evaluations TGA conducted to assess the quality, safety and efficacy of the medicine.|
|What steps were involved in the decision process?||Registration timeline outlining the key steps and milestone dates of the TGA's evaluation and decision process.|
|What post-market commitments will the sponsor undertake?||
Specific conditions of registration from the TGA's approval letter.* Occasionally, conditions may be summarised, shortened or omitted for the purposes of the AusPMDS.
For example, where conditions of registration relating to quality aspects are lengthy or detailed, the conditions may be summarised to be more appropriate for public release.
|Further information||Links to other relevant TGA website pages such as; PI/CMI search page, AusPAR search page, and news pages.|
* Specific conditions of registration are also included in the AusPAR
Commercially confidential and personal information
An AusPMDS will not contain personal information.
As a general approach, the TGA does not release commercially confidential information except where the TGA can justify the release in the public interest and it is lawful to do so - see TGA approach to disclosure of commercially confidential information (CCI) and references to section 61 of the Act under Legislative framework.
Having regard to the sources from which the content of an AusPMDS is compiled, the expectation is that commercially confidential information will generally not be included in an AusPMDS.
Information that is already in the public domain is not considered commercially confidential information.
Sponsor consultation for AusPMDS publication
The expectation is that no sponsor consultation will be required. The main content of an AusPMDS is compiled by the TGA using the public ARTG entry, the approval letter and the PI approved for the medicine (see Table 1).
When an AusPMDS is made available
AusPMDS will only be published for Category 1 and 2 Type A applications for new chemical and biological entities as well as biosimilar medicines (see Table 2). This may change in the future.
Approved submissions only
Where approval is given for a new chemical or biological entity or a biosimilar prescription medicine to be supplied in Australia (whether or not all proposals in the submission were approved), the TGA will aim to publish an AusPMDS (see Table 2).
|Application type||AusPMDS Provided|
|Type A||New chemical or biological entity (if approved)||Yes|
|Type A||Biosimilar medicine (if approved)||Yes|
|Type B||New combination of previously approved active ingredients||No|
|Type C||Extensions of indications||No|
|Type D||Generic medicines||No|
|Type E and F||Major variations||No|
|Type J||Change to ARTG entry - Change to Product Information requiring the evaluation of clinical, non-clinical or bioequivalence data||No|
|All types||Rejected or withdrawn applications||No|
Under section 61 of the Therapeutic Goods Act 1989 (the Act) the TGA can publish information about therapeutic goods. In particular, the following provisions are relevant:
- subsection 61(5A) which provides legislative authority for the Secretary of the Department of Health to release to the public 'therapeutic goods information' relating to any decision or action taken under the Act or the regulations made under the Act;
- subsection 61(5C) which provides legislative authority for the Secretary to release to the public 'therapeutic goods information' of a kind specified under subsection 61(5D);
- subsection 61(5D) which provides that the Minister for Health may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection 61(5C).
The Therapeutic Goods Information Specification 2017 (the 2017 Specification) is a specification, by legislative instrument, made by a delegate of the Minister under subsection 61(5D) for the purposes of subsection 61(5C). The 2017 Specification replaces the Therapeutic Goods Information Specification 2015.
The 2017 Specification sets out various kinds of therapeutic goods information that can be released to the public by the Secretary under subsection 61(5C) and refers to the kind of information included in an AusPMDS.