The Mutual Recognition Agreement between the US and the European Union is gradually taking effect. Since November 2017 FDA recognizes the regulatory authorities of 8 European states. By July 2019 this recognition should be fully bilateral between the US and all 28 EU countries.
8 EU countries meet FDA requirements
A recent FDA press release states that the regulatory authorities of 8 European Member States now meet FDA requirements to conduct inspections of manufacturing facilities. They are:
Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK.
In these 8 countries FDA will no longer perform its own inspections. The US will fully rely on the local regulatory authorities. This is a true milestone. In the FDA press release Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy testifies:
“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 eight regulatory agencies. 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.”
Next step: a fully bilateral FDA – EU agreement
By July 2019 the European Union will also have recognized the FDA regulatory authority. From that moment on the Mutual Recognition Agreement will be a fact. The FDA will no longer conduct any inspections at European countries, and vice versa. A big step forward Dto boost efficiency as FDA emphasizes:
“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.”