
Europe Collaborates on Generic Drugs
The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.
As part of the
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.”
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