Update 2: EU DCP: International collaboration for the evaluation of generic drugs

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.

This is one of the work programs under the IGDRP. Other areas of cooperation in which the TGA is involved include work sharing possibilities in the area of active substance master file, inspection of sites conducting bioequivalence and bio-analytical studies and information sharing on pharmaceutical quality issues.

The TGA is encouraging eligible generic medicines manufacturers to consider taking part in this exciting and ground breaking pilot programme.

Further information about how to participate in the pilot programme can be found below by downloading the EOI documentation package.

Responses to this EOI are requested by 31 March 2015

The below EOI provides information package for the pilot including:

1. List of eligibility criteria.
2. EOI request form to participate in the pilot. The form includes a section seeking consent from sponsors for the EU DCP to share assessment reports with pilot participants and other IGDRP member agencies of the sponsor's choosing in real time.
3. Contact information at participating regulatory agencies.
4. Summary of Quality Differences form.

Please forward the enclosed EOI to the contact points for each selected agency in your EOI. The contact for the TGA is: PCSinbox@tga.gov.au.

Expression of Interest documentation package for generic drug applicants

How to access a pdf or Word document

Please note that the Therapeutic Goods Administration is not the author of these documents.

• Expression of Interest (EOI) to Participate in an Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Decentralised Procedure (DCP) of the European Union (docx,75kb)
• File Summary of quality differences form (docx,82kb)
• Information package - International Generic Drug Regulators Programme (IGDRP) Information Sharing Pilot (pdf,157kb)