EMA’s initiative to enhance cooperation on generics is expanded to include regulators from outside the EU

The European Medicines Agency’s (EMA) initiative to share agency assessments reports aims to facilitate the timely authorization and availability of safe, effective and high quality generic medicines in support of the International Generic Drug Regulators Pilot (IGDRP), and has now expanded to include regulatory agencies worldwide.

The IGDRP was created in 2012 to strengthen the collaboration, convergence and generic development between regulatory agencies worldwide and alleviate challenges of global generic development and approval processes. [Our original article on the IGDRP can be read here: http://regxia.com/blog/ema-to-model-new-international-generic-drug-regulatory-pilot-project-igdrp-after-eu-decentralized-drug-submission-procedure/ ] The IGDRP information-sharing initiative began in 2014 using the EU decentralized procedure as a model, and is now being extended to the centralized procedure. Although the information-sharing initiative is part of the IGDRP, the EU is the lead in this initiative aiming to save global assessment resources and to ease and “strengthen the scientific assessment process for medicines.” An EMA spokesperson, Monika Benstetter, says “the objective of the pilot is to provide for a more efficient and consistent review process while at the same time reducing regulatory burden and facilitating the similar timing of market authorizations across jurisdictions.”

The first phase of the pilot project is expected to involve the EU, Australia, Canada, Chinese Taipei and Switzerland. Additional members of the IGDRP which include Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa, may potentially take part in the future. The EDQM and the WHO will continue to participate as observers to the IGDRP. It is expected that to facilitate the initiation of this pilot only 10 generic medicine applications will be selected to participate. As the progresses additional products may be considered after the evaluation of the initial results have been compiled.

EMA: European Medicines Agency
IGDRP: International Generic Drug Regulators Pilot
EDQM: European Directorate for the Quality of Medicines & Healthcare
WHO: World Health Organization


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