
EU and US Pledge to Recognize Each Other’s GMP Inspections
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
In a landmark decision, the United States FDA and the European Commission
According to an FDA press release, FDA has already observed 14 audits of drug investigators across the EU through the EU’s Joint Audit Programme, including an audit of a Swedish inspectorate by Norway and the United Kingdom. FDA plans to observe more audits throughout 2017. “The enhanced cooperation with US regulatory authorities will improve the EU’s ability to identify and address problems at factories before they become a public health risk,” a
Inspections will be officially recognized beginning in November 2017. The agreement follows a 2012 initiative-the Food and Drug Administration Safety and Innovation Act-which allowed FDA to accept the inspections of foreign regulatory authorities if they were determined to be in alignment with US policies and requirements. Within the text of the agreement, the agencies note that inspection requirements can be considered “equivalent” even if the actual procedures within each agency are not identical.
Any new controls or changes to existing GMP requirements will be discussed by both parties in the spirit of cooperation and information exchange, the text of the agreement explained. For now, the agreement will cover pharmaceuticals made for humans (except for vaccine and plasma-derived products), but by 2019 the committee will make a decision about the inclusion of veterinary products. By 2020, the committee will announce a decision about whether it plans to include vaccines and blood-based products within the product coverage of the agreement.
Sources: FDA, EC
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