EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" was published in the Official Journal of the EU.

The Agreement amends the Sectoral Annex for Pharmaceutical GMPs of the initial EU-U.S. Mutual Recognition Agreement signed in 1998 to include the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human or animal use conducted in the European Union and the United States.

The express inclusion of mutual recognition of GMPs in the EU-U.S. Mutual Recognition Agreement of 1998 allows EU and U.S. regulatory authorities to rely on each other's assessments and official findings resulting from inspections conducted in manufacturing facilities in the European Union and the United States. The mutual recognition of GMP inspections and documentation resulting from such inspections will apply from November 1, 2017.

The Agreement also includes a provision for the waiver of requirements for batch testing of medicinal products for human and animal use on entry of imported products into the European Union and the United States, after a transition phase. The transition phase will last until the United States and the European Union conclude an evaluation of the regulatory and procedural frameworks for GMP inspections of each other's regulatory authorities. On the basis of the Agreement, the European Union must complete its assessment of the U.S. Food and Drug Administration ("FDA") by July 1, 2017, and the United States must assess at least eight EU Member States' competent regulatory authorities by November 1, 2017.

The Agreement provides that the Joint Sectoral Committee must maintain an updated list of all the recognized authorities and serve as a forum to discuss issues related to the Sectoral Annex, such as disagreements on the determination of reciprocal recognitions.

The Agreement's stated purpose is to facilitate cross-border trade of medicinal products and benefit public health by allowing each party to reallocate its inspection resources, including by avoiding duplication of inspections, so as to improve oversight of manufacturing facilities, better address quality risk, and prevent adverse health consequences.

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