EMA to collaborate with other agencies on generics

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EMA to collaborate with other agencies on generics

Home/Policies & Legislation | Posted 30/01/2015 0 Post your comment

The European Medicines Agency (EMA) announced on 19 January 2015 its plans to share assessments reports for generics with regulators outside the European Union (EU).

The aim of the information-sharing initiative is to reduce the time taken to approve generics worldwide and is part of the International Generic Drug Regulators Pilot (IGDRP) [1].

IGDRP was created to promote regulatory collaboration and convergence in generic drug regulatory programmes in order to address challenges posed by increasingly heavy workloads, globalization and the growing complexity of scientific issues. It started in July 2014 using the EU decentralized procedure as a model and has now been extended to the centralized procedure.

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 the IGDRP as observers.

In the initial phase, 10 generics applications will be selected for participation in the pilot; further products might be considered after evaluation of first results.

This is not the first time EMA has collaborated with other regulatory agencies around the world. The agency has already collaborated on inspections with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration [2]. While in December 2013 EMA and FDA launched joint generics inspections [3].

Related article
EMA and FDA report on collaborative efforts

References
1. Baumgärtel C, Gazda-Pleban K. Generics authorization – groundbreaking regulatory approach to closer international cooperation on the rise – IGDRP. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(1):48. doi:10.5639/gabij.2015.0401.011
2. GaBI Online - Generics and Biosimilars Initiative. Pilot programmes between EMA, FDA and TGA a success [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Generics/General/Pilot-programmes-between-EMA-FDA-and-TGA-a-success
3. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA launch joint generics inspections [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-launch-joint-generics-inspections

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Source: EMA, WHO