EU-US FDA Mutual Recognition of Inspections of Medicines Manufacturers Enters New Operational Phase

• 05/03/2018
• Articles

On 1 March 2018 the European Commission and the European Medicines Agency (“EMA”) announced that four further Member States have been included in the arrangement with the Food and Drug Administration (“FDA”) of the US for the mutual recognition of inspections of manufacturing sites for human medicines. The four Member States at issue are Czech Republic, Greece, Hungary and Romania and join a group of eight Member States which had already entered the system of mutual recognition alongside the United States on 1 November 2017 (see VBB alerts of 7 March 2017 and 3 November 2017).

 
From the US perspective, medicine manufacturing regulatory authorities in 12 EU Member States have now been recognised as capable to carry out good manufacturing practice (GMP).  The remaining Member States will be assessed by the FDA on a rolling basis, to be completed by 15 July 2019.
 
The EMA’s announcement can be found here.