About Australian prescription medicine decision summaries (AusPMDSs)
The Australian prescription medicine decision summary (AusPMDS) provides a brief overview of the TGA’s assessment and decision to approve or not approve registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
We have redesigned our prescription medicine decision summaries (AusPMDSs) to make it easier to understand how prescription medicines are registered in Australia.
The redesigned AusPMDSs will offer clear, accessible information about recent medicine registration decisions.
AusPMDS dataset
Click the button below to view or search for an AusPMDS.
Australian prescription medicine decision summaries
The first AusPMDS was published in September 2019.
In 2025 the TGA redesigned AusPMDSs to improve clarity and accessibility, with the new format available from December 2025.
What are AusPMDSs
Australian prescription medicine decision summaries (AusPMDSs) provide a brief overview of the TGA’s assessment and decision to approve or not approve a new prescription medicine.
AusPMDSs include brief information about:
- what the medicine was approved for
- how the medicine works
- why the medicine was approved or not approved for registration in Australia.
AusPMDSs are generally published for new prescription medicines (Type A and B Applications) and reflect the outcomes of the initial assessment. They are not updated to include any subsequent changes, so may not represent the most current information for a medicine.
For current information about a medicine, refer to the Consumer Medicine Information (CMI), Product Information (PI), or search the ARTG by using the medicine name, ARTG identification number, or sponsor name.
The medicine’s sponsor is given an opportunity to verify the accuracy of an AusPMDS before it is published on the TGA website.
TGA prescription medicine assessment and decision-making process
For more information see Australian regulation of prescription medical products.
A flow diagram showing six steps in the TGA prescription medicine assessment and decision-making process. This includes:
- sponsor submits application to the TGA,
- TGA assesses the application,
- TGA requests advice (if required),
- TGA decision to approve or not approve the medicine registration,
- TGA registers medicine in ARTG if approved, and
- TGA publishes the Australian prescription medicine decision summary.
Note: sponsors can request a review under Section 60 of the Therapeutic Goods Act 1989 if they disagree with the initial decision.
Purpose of AusPMDSs
We publish AusPMDSs to ensure timely, accessible information is available and to support transparency and trust in the TGA’s prescription medicine assessment process.
An AusPMDS is not medical advice and should not be used to prescribe, diagnose, treat, or manage any medical condition.
Consumers seeking guidance on the safe and effective use of a medicine should consult the Consumer Medicine Information (CMI).
For clinical decision-making, healthcare professionals should refer to the approved Product Information (PI).
Legal framework for AusPMDSs
The TGA is authorised to publish information about therapeutic goods under section 61 of the Therapeutic Goods Act 1989. This includes the information included in AusPMDSs and Australian public assessment reports (AusPARs).
You can find out what prescription medicines information can be published by the TGA in the following legislation:
- Therapeutic Goods Information Specification 2017
- Therapeutic Goods (Prescription Medicines – Sharing of AusPARs) (Information) Specification 2023
- Understanding Australian Public Assessment Reports (AusPARs) for prescription medicines.
Section 60 review of an initial decision
If a sponsor disagrees with the TGA’s initial decision, they may ask for a review of their application under Section 60 of the Therapeutic Goods Act 1989. This review process allows a sponsor to seek reconsideration of their application by the Australian Government Minister for Health, Disability and Ageing. For more information on Section 60 reviews refer to requesting the Minister for Health to reconsider the initial decision.
If a sponsor is not satisfied with the Minister’s reconsideration of an initial decision, they may apply to the Administrative Review Tribunal (ART) for a further review of their application.
More information
Consumer Medicine Information (CMI)
The Consumer Medicine Information (CMI) leaflet offers guidance to help consumers use the medicine safely and effectively. It includes information on dosage, how to use the medicine properly, potential side effects, safety precautions, storage instructions, and more.
Product Information (PI)
The Product Information (PI) document provides essential prescribing guidance for health professionals. It includes details on dosage recommendations, pregnancy category, contraindications, precautions, and potential side effects.
Australian Public Assessment Reports (AusPARs)
AusPARs provide detailed information about the TGA’s assessment of prescription medicine registration applications. They outline the evidence submitted to the TGA and the considerations that informed the decision to approve or not approve the medicine for registration in Australia.
We aim to publish AusPARs within 3 months of the TGA’s decision to register or not register a prescription medicine in the ARTG.
For more information on AusPARs refer to the About Australian public assessment reports (AusPARs) webpage.
Other resources
For health advice and information, including a symptom checker and service finder, refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines), call Medicines Line.
For information on medicines subsidised by the Australian Government, refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia, refer to the Australian Institute of Health and Welfare website.
Related TGA information
If you think you are experiencing a side effect from a medicine or vaccine, seek advice from a health professional as soon as possible.
For information on how to report a side effect from a medicine or vaccine, refer to report an adverse event or safety problem.
ARTG entries include the product name and formulation, sponsor and manufacturer details, and links to the Consumer Medicine Information (CMI) and Product Information (PI), where available. Please note that not all CMI and PI documents are published. You can search the ARTG using the medicine name, ARTG identification number, or sponsor name.
For information on prescription medicines and how they are regulated, refer to
prescription medicines.
Page history
Page updated to reflect changes to layout of Australian prescription medicine decision summaries
Page updated to reflect changes to layout of Australian prescription medicine decision summaries