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Regulatory decisions and notices (prescription medicines)
Prescription medicines regulatory decisions
- Australian prescription medicine decision summaries
The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine
- Australian Public Assessment Reports for prescription medicines (AusPARs)
An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application
- Prescription medicines determination and designation notices
Before a sponsor can access the priority review pathway or the orphan drug fee waiver, they must first be granted a relevant designation by the TGA. This page lists all prescription medicines that are eligible for one or more designations from 1 July 2017
- Prescription medicines: new registrations
TGA publishes information on new prescription medicines as they are approved
Prescription medicine notices
Older, revoked and superseded notices are available in the TGA Internet site archive.
- New Early Scientific Advice service to support medicine registrations
22 September 2020: TGA has launched the new Early Scientific Advice service, allowing applicants to request advice on biowaiver justifications.
- Reforms to the generic medicine market authorisation process: implementation update
17 December 2019: The TGA has reduced requirements for use of overseas reference products in bioequivalence studies and added new optional forms for summarising bioequivalence and biowaiver study data.
- N-nitroso compounds in 'sartan' blood pressure medicines
15 September 2019: Introduction of requirements for sponsors of sartan medicines
- Updates to variations to prescription medicines guidance and e-form
10 July 2019: The TGA Business Services online application system for variations to prescription medicines has been updated
- Reform of the orphan drug program - End of transition arrangements
7 June 2018: End of transition arrangements for orphan drugs designated under the previous program