European and U.S. Regulators Agree on Mutual Recognition of Inspections

Regulators in the European Union (EU) and the U.S. have agreed to recognize inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.

Under the deal, regulators will rely on each other’s inspections of production sites of medicinal products to ensure compliance with Good Manufacturing Practice (GMP). In the future, the need for an EU authority to inspect a site located in the U.S., or vice versa, will be limited to exceptional circumstances, according to a press release issued on March 2nd by the European Medicines Agency (EMA).

The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or U.S. markets are manufactured, noted the EMA.

“This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union,” it stated.

In the EU, inspections of manufacturing sites are carried out by national competent authorities from EU member states, but EMA helps coordinate these activities.

The agreement is an annex to the EU-US Mutual Recognition Agreement (MRA), which was signed in 1998 but is not yet implemented. Many provisions of the agreement have already entered into force and others will enter into force on November 1st 2017, the statement continued. By that date, the EU will have completed its assessment of the FDA and the FDA is expected to have completed its assessment of at least eight EU member states, and will be gradually expanded to all member states. The text of this agreement is now published on the website of the European Commission’s Directorate General for Trade.

Philip Ward is the European Editor for Applied Clinical Trials