News about GMP/cGMP

02.11.2017

EU-US Mutual Recognition of Inspections Enters Operational Phase

As of 1 November 2017, the Mutual Recognition Agreement (MRA) between the European Union and the United States enters the operational phase. The MRA, which will allow to recognise inspections of manufacturing sites for human medicines conducted in each partners’ respective territories shall update the agreement dating back to 1998.

The proceedings have again picked up speed. The US FDA has now published the names of the first eight European Member States, that – according to the FDA – got the confirmed capability, capacity and procedures in place to carry out GMP-inspections at a level equivalent to the EU. To anticipate it: Germany is not included! The countries listed are:

Austria
Croatia
France
Italy
Malta
Spain
Sweden, and
the United Kingdom.

The remaining inspectorates will continue to be assessed until 15 July 2019.

The start of the operational phase is considered to be a major milestone and a testimony to mutual trust. It is unprecedented as the FDA has never before recognised another country’s inspectorate. It is also a major milestone towards closer cooperation to improve the use of available resources to safeguard quality and safety of medicines. This addresses the fact that around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the Union.

To answer frequently asked questions on the subject, the EMA has also released a Q&A paper on the impact of the MRA. The document including 10 O&As can be found here. To read the EMA's press release, please click here.