Regulatory decisions and notices (prescription medicines)
Prescription medicines regulatory decisions
- 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Older, revoked and superseded notices are available in the TGA Internet site archive.
2017
- Explanatory document for Seasonal influenza vaccines – quality module
30 August 2017: Sponsors are invited to provide comment on this guidance by 26 October 2007 (8 weeks from publication date) - Priority review pathway: prescription medicines
26 June 2017: Implementation of a Priority review pathway for the registration of novel prescription medicines - Orphan drug program reforms
26 June 2017: Implementation of reforms to the orphan drugs program - Reform of the Orphan Drug Program - Transition arrangements
1 May 2017: Letter to sponsors about transition arrangements for changes to the Orphan Drug Program