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EU-US Mutual Recognition of Manufacturer Inspections – start of operational phase

Nov 27th 2017

On 1st November 2017, the European Union and the United States entered into a new phase of the agreement to recognise inspections of manufacturing sites for medicinal products conducted in their respective territories.

Previously, in June 2017, the EC confirmed the capabilities, capacity and procedures of the FDA as suitable to carry out GMP inspections. On 31 October 2017, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The FDA will continue to assess the remaining EU inspectorates until July 2019.

This is the first time the FDA has recognised any other country’s inspectorate.

This collaboration enables a more efficient use of resources and, ultimately, will allow more focus on sites of higher risk. It also addresses the fact that for 85% of medicines sold in the EU, at least one manufacturing step takes place outside the EU.

  • For more information please visit EMA website

 

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