Ing. Helmut Schütz

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EMA-FDA GCP Initiative

EU – EMA and U.S. FDA

Following the joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities in 2009 (see here), the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) 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.

See also the press releases of 2013-12-18: EMA and  FDA.

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.

The 18 months pilot phase will start on January 2^nd, 2014. Details are given by the EMA and  FDA.