FDA and European Medicines Agency Announce Generic-Drug Application Inspections Initiative

FDA and the European Medicines Agency (EMA) have announced a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic-drug approvals. The initiative creates a process to conduct joint facility inspections for generic-drug applications submitted to both agencies. Objectives of the initiative are to streamline the sharing of information of bioequivalence studies conducted for generic-drug applications, to share negative inspection outcomes, to conduct joint inspections internationally, and to provide training to improve inspections.

“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, in a press release. “By streamlining the inspection process for generic drug applications, we will help consumers gain access to safe and effective generic drugs.”

Taking part in the initiative are the EMA and the EU member states France, Germany, Italy, the Netherlands, and the United Kingdom. This initiative will be implemented using the confidentiality arrangements established among the European Commission, the EMA, interested EU member states, and FDA. This agreement includes an 18-month pilot phase and follows the 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.

Source: FDA.gov