EU and US agree on mutual recognition of manufacturing site inspections

Regulators in the European Union (EU) and the United States (US) have finally struck a deal to recognise each other’s inspections of manufacturing sites for human medicines.

Each year, national competent authorities from the EU and the US Food and Drugs Administration (FDA) inspect many manufacturing sites in the EU, the US and across the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s inspections of finished pharmaceutical product and active pharmaceutical ingredient (API) manufacturing facilities in their own regions.

The agreement will allow the EU and US inspectors to allocate more resource on inspections in other parts of the world where APIs and finished products for the EU or US markets are made.

Regulis comments that it is great to see this transatlantic agreement finally reached. It has been a long time coming and it should help to make better use of agency inspection capacity and reduce duplication of effort. This will see quicker drug approvals and well as save money for drug’s manufacturers.

The EMA already has similar mutual recognition GMP agreements in place with Australia, Canada (with some limitations), Israel (with some exclusions), Japan, New Zealand and Switzerland.

The text of the agreement is now published on the website of the European Commission’s Directorate General for Trade here.

The EMA and FDA press releases can be read in full here (EMA) and here (FDA).