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The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.
As part of the International Generic Drug Regulators Pilot (IGDRP), the European Medicines Agency (EMA) is providing the agency’s assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU). EMA is sharing the assessments as part of an information-sharing initiative to ensure timely authorization and availability of generic drugs.
IGDRP was started in July 2014 using the EU-decentralized procedure as a model, and it is now extended to the centralized procedure. According to the EMA, the aim of the pilot is 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.”
Source: European Medicines Agency