FDA to Rely on GMP Inspections Conducted by 4 More EU Member States

The FDA and the European Medicines Agency (EMA) announced today that the mutual recognition agreement between the European Union and the United States now includes 4 additional EU member states: Czech Republic, Greece, Hungary, and Romania.

The extension of the agreement signals the FDA’s confirmation that these 4 states can carry out good manufacturing practice (GMP) inspections equivalent to those conducted by the FDA. The EMA says that all EU member states will be recognized by the FDA by July 2019, with 2 more additional member states slated for FDA recognition by June 2018 and a further 6 member states scheduled for December 2018.

Initially, the EU and FDA will focus on inspections that are conducted within their own respective territories, but the nations represented in the agreement have the option to rely on inspection reports issued by any other recognized authority for manufacturing facilities located outside their respective territories. Each year, according to the EMA, about 40% of all finished medicines that are marketed in the European Union are imported from overseas. For approximately 85% of medicines sold in the European Union, at least 1 manufacturing step takes place in a foreign territory.

Mutual recognition, says the EMA, not only helps EU and US regulators to avoid duplicative efforts and better allocate their inspection-related resources, but also improves the agencies’ abilities to identify and address potential problems at sites before they become public health risks.

Today’s announcement follows a November 2017 announcement that the respective agencies of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom would be recognized as capable of conducting GMP inspections that meet the FDA’s specifications and an August 2017 announcement that the FDA would share full inspection reports with both the EMA and the European Commission (EC). While the FDA had previously maintained confidentiality agreements with the EMA and EC since 2003, these earlier arrangements did not include the US’ ability to share full reports, inclusive of commercially confidential information such as trade secrets.