cGMPs

FDA and EMA Launch Joint Generics Inspections Initiative

Source: FDA

Jan 08, 2014

The U.S. Food and Drug Administration and the European Medicines Agency have 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.

Read the FDA press release