11 August 2020
With 1 November, the EU-FDA Mutual Recognition Agreement (MRA) of GMP inspections of human manufacturers came into operation. This starts with the recognition of the FDA and the first 8 EU Member States. In a press release, the U.S. Food and Drug Administration states that the agency "will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements": Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom. This list of eight authorities may look short or a bit strange, but this is based on the date when each of the authorities was assessed. It does not necessarily mean that other countries failed the process. Other EU member states will be added as their evaluation is completed by the US; until all agencies have been assessed and recognised by 15th July 2019.
And what about the EU accepting FDA inspections?
A few weeks ago, the European Commission stated that the FDA "has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU." A separate agreement with the European Commission enabled FDA to share commercially confidential information with its European counterparts.This assessment (re-)started in 2014. In 2015 the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) agreed to lead the EU team. As part of the assessment, the team visited FDA's headquarters at White Oak in Maryland and three district offices (Detroit, Kansas City and Philadelphia) and a FDA laboratory.
The final completion of these assessments should then enable the FDA and the EU to mutually accept inspections of the other agencies. This should also allow regulators to better direct resources to manufacturing facilities in other countries. "By partnering with these countries we can create greater efficiencies and better fulfill our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries," said FDA Commissioner Scott Gottlieb, M.D.