Joint FDA-EMEA Inspections Program Outlined

The FDA and the European Medicines Agency (EMEA) will pilot a joint good manufacturing practice (GMP) inspections program under a bilateral agreement.

Following a meeting of the Transatlantic Economic Council, the European Commission (EC) characterized the FDA and EMEA’s relationship as a beneficial cooperation. The EC lists new GMP initiatives the two agencies will undertake.

The joint inspections program will apply to facilities in both the U.S. and the European Union (EU), the EC said. Joint inspections of active pharmaceutical ingredient (API) facilities in countries outside the U.S. and the EU will be part of the program as well.

The agencies will pilot a GMP information exchange covering inspection schedules and results. Information on facilities that have been inspected would be shared so the agencies could get greater inspection coverage and better identify API production sites in countries outside the U.S. and the EU.

“The collaboration on inspections should result in more effective use of resources and a higher safety level of product from third countries,” the EC said.