The TGA is participating in an international collaboration programme led by the European Union (EU) under the auspices of the IGDRP through which, upon request from a generic pharmaceutical company, the assessment reports generated as part of EU Marketing Authorisation procedures will be shared in real time with collaborating regulatory agencies outside the EU such as the TGA.

The IGDRP was launched in April 2012 with the aim of regulatory agencies to pursue collaboration and convergence to mitigate challenges of worldwide generic global development and approval programs. As part of the IGDRP, an information sharing pilot has been initiated in July 2014 using the European Union's Decentralised Procedure (DCP) as a model for the sharing of information during the scientific assessment phases of the DCP with IGDPR non-EU agencies, including the TGA.

It has now been agreed that, from January 2015, the pilot will be extended to applications for generic medicinal products through the Centralised Procedure. In the initial phase, 10 applications for generic products will be selected for participation to the pilot; further products might be considered after evaluation of the results of the initial phase. An outline of the process and information on how to express interest for participation to the pilot are published on the Related Documents section of this website.

By allowing to share assessment reports with non-EU regulatory agencies like the TGA, will assist collaboration and information-sharing between regulatory authorities across the world, contributing to facilitating and strengthening the scientific assessment process for medicines. This should enable medicines to be authorised in different territories in a coordinated way at approximately the same time. 

The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland. Other members of the IGDRP may decide to take part in the pilot programme at a later stage. These include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa. The European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization (WHO) participate in IGDRP meetings as observers.

For more details, go to: https://www.tga.gov.au/media-release/update-2-eu-dcp-international-collaboration-evaluation-generic-drugs