International cooperation

At the Therapeutic Goods Administration (TGA), we work closely with overseas regulatory agencies.

• 2 June 2023
  TGA supports MHRA’s new international recognition framework for medicines
  The TGA supports MHRA's new international recognition framework. These international recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, are part of a new international recognition framework for medicines that is specific to the UK following their exit from the European Union.
• The TGA and MHRA formed a Joint Committee to implement the practical details of the medical device sectoral annex of the Australia - UK Mutual Recognition Agreement (MRA). See Medical devices reforms: Mutual Recognition Agreements (MRA).
• 9 August 2021
  Therapeutic Goods (International Agreement-Notice of Prohibition) (Minamata Convention on Mercury) Instrument 2021
  The Minamata Convention facilitates a global approach to address concerns relating to mercury, which is persistent, toxic and highly mobile in the environment once released, and recognised as a substance producing significant neurological and other effects in humans.
   
• 19 December 2019
  Launch of international pilot programme on inspection of manufacturers of sterile medicines
   
• 7 December 2016
  The Medical Device Single Audit Program (MDSAP) aims to strengthen existing international cooperation in the field of medical device evaluation.
   
• 24 September 2015
  The TGA joined the IMDRF pilot to test the ToC submission format.
   
• 17 June 2014
  TGA joins European Directorate for the Quality of Medicines and HealthCare (EDQM) CEP assessment process
   
• 30 November 2012
  Medical device amendments to the EU-Australia MRA on conformity assessment. Amendments come into effect on 1 January 2013.
   
• 11 February 2005
  Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement came into force on 1 January 2005.