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Five Further Member State Inspectorates Recognised under EU - US Mutual Recognition System for Medicines

  • 03/12/2018
  • Articles

The Agreement on Mutual Recognition between the European Union and the United States of America continues its roll-out in the realm of pharmaceutical inspections. On two separate occasions in November 2018, the US Food and Drug Administration (“FDA”) added 5 new EU Member States to its list of countries which it considers to have capable inspectorates to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that observed in the US. These Member States are Belgium, Denmark, Estonia, Finland and Latvia. The updated list of in total 20 Member States whose inspection results the FDA considers can replace its own inspections can be found here:
https://www.fda.gov/internationalprograms/agreements/ucm598735.htm.
 
The EU and the US thus seem to be on track to have all EU Member States recognised as capable of carrying out pharmaceutical inspections by 15 July 2019. For its part, the FDA had already been earmarked as a capable inspectorate on 1 November 2017.

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