European and US regulators’ agreement on mutual recognition of inspections of medicines manufacturers

In the European Union (EU), inspections of medicines manufacturing sites are carried out by national competent authorities from EU Member States. Each year, EU competent authorities and the US Food and Drug Administration inspect many manufacturing sites in the EU, US and elsewhere in the world, to ensure compliance with Good Manufacturing Practice (GMP).

EU and US regulators have agreed to recognise inspections of manufacturing sites for medicines conducted in their respective territories. The agreement is underpinned by an assessment that the EU and US have comparable regulatory and procedural frameworks. In future, the need for an EU regulator to inspect a site located in the US, or vice versa, will be limited to exceptional circumstances.

The agreement is an annex to the EU-US Mutual Recognition Agreement (MRA). Many provisions of the agreement have already entered into force and others will enter into force on 1 November 2017. The EU has existing MRAs of GMP inspections for several other countries including Canada, Australia, New Zealand, Japan and Switzerland.