FDA and EMA Collaborate for Generic Drug Inspection Initiative

The two organizations launch a generic drug inspection initiative to support drug approvals

According to a press release from the FDA, the organization has partnered with the European Medicines Agency (EMA) to launch an initiative to “share information on inspections of bioequivalence studies submitted in support of generic drug approvals.” The joint initiative hopes to facilitate an easier process for approving generic drugs.

The inspections initiative will provide a mechanism by which both organizations can conduct facility inspections for generic drug applications that were submitted to both organizations, which allows for a quicker, more streamlined process. According to the press release, studies submitted for generic drug applications must show that a drug is bioequivalent and performs in the same manner as the name brand drug.

The initiative hopes to streamline information sharing on inspections of bioequivalence studies, share information about negative inspection outcomes, conduct joint inspections at facilities all over the world and provide training opportunities to improve inspections.

In Europe, participating counties include France, Germany, Italy, The Netherlands and the United Kingdom. 

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  • OHS Magazine Digital Edition - June 2022

    June 2022

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