
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 - 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Older, revoked and superseded notices are available in the TGA Internet site archive.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
2015
- Prescription medicines: pre-submission pilot
14 December 2015: The TGA is introducing pilot changes to the pre-submission phase of the prescription medicines registration process - Receiving prescription medicine streamlined submission evaluation reports by email
14 April 2015: The TGA case management team is sending prescription medicine streamlined submission evaluation reports via email to organisations that have registered for secure email
2014
- Updated pre-submission planning form
9 May 2014: Amendments have been made to the prescription medicines pre-submission planning form - Cessation of acknowledgement letters for Category 3 submissions
22 April 2014: Applicants of Category 3 prescription medicine submissions will no longer be issued with an acknowledgment letter advising of the receipt of their submission