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

2017

Older, revoked and superseded notices are available in the TGA Internet site archive.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