Some therapies approved in the United States are either fully manufactured overseas or made domestically but contain some foreign ingredients.
Officials with the FDA will recognize 8 European drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom as capable of conducting inspections of manufacturing facilities that meet FDA requirements, according to a statement from the agency released today.
This achievement marks an important milestone to successful implementation and operationalization of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA) that enables US and EU regulators to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
Some therapies approved in the United States are either fully manufactured overseas or made in the US but contain some foreign ingredients. All drugs approved in the United States, regardless of where they are made, must comply with applicable regulations. One way the FDA oversees drug manufacturing is by routinely inspecting domestic and foreign drug manufacturing plants for compliance with manufacturing standards that assure quality and product label requirements.
“Beginning November 1 we will take the unprecedented and significant step forward in realizing the key benefits of the Mutual Recognition Agreement with our European counterparts in that we will now rely on the inspectional data obtained by these 8 regulatory agencies,” Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy said in the statement. “The progress made so far puts us on track to meet our goal of completing all 28 capability assessments in the EU by July 2019.”
In June 2017, the European Commission determined that the FDA “has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.” The completion of these capability assessments enables the FDA and the EU to avoid duplication of drug inspections and allows regulators to devote more resources to other manufacturing facilities in countries where there may be greater risk.