EMA to boost international cooperation on generics
The European Medicines Agency is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union. This initiative aims to facilitate the timely authorization and availability of safe, effective and high quality generic medicines worldwide.
The information-sharing initiative is part of the International Generic Drug Regulators Pilot (IGDRP). It started in July 2014 using the European Union decentralized procedure as a model, and it is now extended to the centralized procedure.
The EU is leading this initiative with the aim to both save global assessment resources and to facilitate and strengthen the scientific assessment process for medicines. It is expected that this sharing of assessments will allow authorization of generic products in concerned countries in a coordinated and resource effective way.
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