US extends recognition of EU drug plant inspections to four countries

By Murielle Gonzalez | Published: 4-Dec-2018

Belgium, Denmark, Finland, Latvia and Estonia will now be recognised by the FDA

The US Food and Drug Administration (FDA) has announced the addition of Belgium, Denmark, Finland, Latvia and Estonia to the Mutual Recognition Agreement (MRA), the document signed between the agency and the European Union allowing drug inspectors to rely upon information from drug inspections conducted within each other’s borders.

These additions increases to 20 EU member states that are now mutually recognised.

The FDA and the EU have collaborated since May 2014 to evaluate the way they inspect drug manufacturers and assess the risk and benefits of mutual recognition of drug inspections.

As part of the MRA, the FDA will continue to perform some inspections in EU countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. However, FDA expects to perform fewer routine surveillance inspections in EU countries with a capable inspectorate.

The FDA expects to complete the capability assessment of all of the EU inspectorates by July 2019.

CT understands the FDA plans to assess expansion of the agreement to cover veterinary medicines by July 2019 and vaccines for human use and plasma-derived medicines by July 2022.

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