Luxembourg and the Netherlands Added to EUUS Inspections Agreement

13 June 2019

BioPharm International

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

The European Medicines Agency (EMA) announced on June 10, 2019 that Luxembourg and the Netherlands have been included into the mutual recognition agreement between the European Union and the US FDA that mutually recognizes good manufacturing practice (GMP) inspections of manufacturing facilities by other territories. These additions bring the number of EU Member States that FDA recognizes as performing GMP inspections equivalent to the United States to 26. The EU has recognized FDA inspection results as equivalent to the EU since 2017.

The plan is to have all EU Member States as part of the agreement by July 15, 2019. EMA stated in a press release that the agreement “strengthens reliance on each other's inspection expertise and resources.” The agreement allows EMA and FDA to focus inspection resources to other parts of the word, prioritize high-risk facilities, reassure the public about the safety of medications, better identify potential problems at manufacturing sites, and reduce administration burdens.

“The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA, and the FDA have been auditing and assessing the respective supervisory systems since May 2014 and are working closely together to reach the agreement’s milestones,” the agency stated in the release.

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