For the first time, the FDA has decided to allow external agencies to carry out manufacturing inspections on its behalf. FDA-approved drugs that are manufactured outside the US (or US manufactured drugs that contain foreign ingredients) sometimes undergo FDA inspections at the site of manufacture (or site of production in the case of foreign ingredients), meaning agency workers are dispatched to those areas – a cumbersome and time-consuming routine for both the FDA and manufacturers. To help consolidate the process, the FDA has enacted the 1998 US-EU Mutual Recognition Agreement and its subsequent amendments that allows US and EU regulators to use each other’s GMP inspections for pharmaceutical manufacturing facilities.
As of November 1, 2017, regulatory agencies in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK can conduct inspections on the FDA’s behalf, subsequently sending the data back to the US regulator. The remaining EU member states will be also assessed for the initiative, with the last due to be concluded by July 15, 2019. Since the Mutual Recognition Agreement is a two-way street involving EU member states, the European Commission was also part of the decision process. It deemed that the FDA “has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU” (1).
Newsletters
Receive the latest analytical science news, personalities, education, and career development – weekly to your inbox.
References
- U.S. Food & Drug Administration, “FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections”, (2017). Available at: http://bit.ly/2y9UPn6. Accessed November 15, 2017.
