The U.S. Food and Drug Administration and the European Medicines Agency have launched a joint initiative to share information on bioequivalence studies in generic drug approval applications.
Bioequivalence studies are required for generic drug applications to prove the generic drug works in the same way as the brand name drug.
To ensure submitted data is reliable, the FDA and regulatory bodies of the European Union inspect facilities conducting the studies, and this new initiative also allows the FDA and EMA to conduct join inspections.
France, Germany, Italy, the Netherlands and the United Kingdom are the EU and EMA member states participating in the joint initiative.
The joint initiative hopes to streamline and enhance information exchanges between the two agencies.
This venture follows the successful Good Clinical Practices Initiative from 2009 jointly created by the FDA and EMA to ensure clinical trials for drug marketing applications are ethically and reliable conducted.
There will be an 18-month pilot phase for this new program beginning on Jan. 2.
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