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

2017 2015 2014

Older, revoked and superseded notices are available in the TGA Internet site archive.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