The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have agreed to mutually recognize inspections of drug manufacturing sites for human medicines. Under the landmark agreement, which is set to begin on November 1, 2017, the need for an FDA authority to inspect a site located in the EU, or vice versa, will be limited to exceptional circumstances.
In a press release (1), the FDA said, “Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.” Both agencies have been edging closer to mutual recognition for a number of years. In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities, as long as the FDA determined those authorities were capable of conducting inspections that met US requirements. And since May 2014, the FDA and the EMA have been working closely to evaluate the risk and benefits of mutual recognition of drug inspections. “The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines,” said the EMA in a press release (2). According to an FDA document (3), the agreement is between the US and the EU (not with individual national regulatory agencies), but the FDA has set out to conduct an assessment of each country’s regulatory authority individually by July 15, 2019. The agreement will cover “a broad range of human drugs and biologics and veterinary drugs with specific exclusions.” The document also states that inspections of “facilities manufacturing vaccines and plasma derived products are not immediately included within the scope of the agreement,” but that this will be re-evaluated no later than July 15, 2022.
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References
- FDA, “Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union”, (2017). Available at: http://bit.ly/2me0Snv. Accessed March 8, 2017. EMA, “European and US regulators agree on mutual recognition of inspections of medicines manufacturers”, (2017) Available at: http://bit.ly/2lBCcRL. Accessed March 8, 2017. FDA, “Frequently Asked Questions / The Mutual Recognition Agreement”, (2017). Available at: http://bit.ly/2n6AFse. Accessed March 8, 2017.
