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The FDA Abroad

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).

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  1. U.S. Food & Drug Administration, “FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections”, (2017). Available at: Accessed November 15, 2017.
About the Author
William Aryitey

My fascination with science, gaming, and writing led to my studying biology at university, while simultaneously working as an online games journalist. After university, I travelled across Europe, working on a novel and developing a game, before finding my way to Texere. As Associate Editor, I’m evolving my loves of science and writing, while continuing to pursue my passion for gaming and creative writing in a personal capacity.

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