The EU-FDA mutual recognition of GMP inspection of medicines manufacturing site is now operational

Earlier this year, the European Commission determined that Good Manufacturing Practice (GMP) inspections of medicine manufacturing sites carried out by the US Food and Drugs Administration were compliant with EU requirements, and therefore the inspection reports would be recognised.

From 1st November 2017, a further step forward has been taken in the mutual recognition agreement between the EU and the US. The FDA has confirmed that GMP inspections carried out by the regulatory authority inspectors from Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK are now recognised to be equivalent to those carried out by FDA. The 20 remaining EU countries will be assessed by July 2019.

Although USA is the 7th country that the EU has a mutual agreement with for GMP inspections (other countries being Australia, Canada, Israel, Japan, New Zealand and Switzerland), it is the first time the FDA recognise another country’s inspection.

Click on the agency names to consult the press releases from the EMA and FDA respectively.