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
  The TGA publishes information on new prescription medicines as they are approved
• Prescription medicines: applications under evaluation
  List of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA

Prescription medicine notices

2021 2020 2019 2018

Trove at the National Library of Australia has copies of older, revoked and superseded notices - external site.

2021

• Changes to the Medicine Shortage Reporting system
  02 June 2021: We are improving the Medicine Shortages IT System.

2020

• 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.

2019

• 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

2018

• 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