FDA To Leverage EU Inspections of European Production Sites

Regulators in the European Union and the United States have agreed to recognize inspections of manufacturing sites for human medicines performed by the other agency. Each year, authorities from the EU and the FDA inspect the same production sites in the US and EU. Under the new agreement, EU and US regulators will rely on each other’s inspections in their own territories. In the future, EU authorities will only inspect a site located in the US under exceptional circumstances. The same will be true for US authorities and sites in the EU.

The agreement is based on evidence that both the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014, and have worked closely together to reach this agreement.  The EU will have completed its assessment of the FDA and the FDA is expected to have completed its assessment of at least eight EU Member States by November 1, 2017. The US agreement will be gradually expanded to all Member States after that date. (Source: EMA Website, 02 March, 2017)

For more information, visit: http://www.ema.europa.eu/ema/