EMA to model new International Generic Drug Regulatory Pilot Project (IGDRP) after EU Decentralized Drug Submission Procedure

The International Generic Drug Regulators Pilot (IGDRP) was created in 2012 to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads, globalization and complexity of scientific issues.

The European Medicines Agency (EMA) has chosen to model the IGDRP after the European Union’s (EU) decentralized procedure (DCP) for assessing applications for generic medicines. DCP allows medicines to be authorized simultaneously in more than one EU country if it has not yet been authorized in any EU country. The EU believes this pilot project will facilitate timely authorization and availability of safe, effective and quality generic medicines.

In this project, at the request of a generic company, the EU “will share the assessment reports…in real time with collaborating regulatory agencies outside the EU.” The outcome of this project “should enable medicines to be authorised in different territories in a coordinated way at approximately the same time.”

The first phase of this project will only include the EU, Australia, Canada, Chinese Taipei and Switzerland. Other IGDRP members such as Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa may decide to join at a later time. Observers for this pilot project include the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organization.

The EMA announcement regarding the IGDRP and links on how to participate in the pilot program can be found here:

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