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FDA and European Medicines Agency Launch Generic Drug Application Inspections Initiative

Wed, 12/18/2013 - 1:36pm

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

Studies submitted for generic drug applications must demonstrate scientifically that a generic drug is “bioequivalent.” These studies help demonstrate that the generic drug performs in the same manner as the brand name drug. The FDA and the regulatory authorities in the European Union (EU) inspect facilities that conduct these studies to ensure data submitted to the agencies are reliable.

Taking part in this initiative are the EMA and the EU member states France, Germany, Italy, the Netherlands and the United Kingdom.

“Our continued collaboration with the EMA and the EU enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs.”

Key objectives of the initiative are to:

• streamline information sharing on inspections of bioequivalence studies conducted and planned for generic drug applications (inspectional information will be shared for clinical facilities, analytical facilities or both);
• share information about negative inspection outcomes that reveal system problems at a facility;
• conduct joint inspections at facilities all over the world; and
• provide training opportunities to improve bioequivalence inspections.

This initiative will be implemented using the confidentiality arrangements established among the European Commission, the EMA, interested EU member states and the FDA.

This agreement includes an 18-month pilot phase and follows on the successful 2009 EMA-FDA Good Clinical Practices (GCP) Initiative, designed by the agencies to ensure that clinical trials data submitted in new drug applications in the United States and Europe are conducted ethically and are reliable.

For more information:

•  EMA-EU MSs-FDA initiative on inspections for Generic Applications

http://www.fda.gov/downloads/InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/UCM378980.pdf

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