US and EU Agree on Mutual Recognition of Drug Manufacturing Inspections

The United States and the European Union (EU) announced that they have agreed to mutually recognize each other’s pharmaceutical manufacturing inspections, an agreement that is likely to mean less duplication of inspections and thus lower costs for both the EU and United States.

Under the Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement, US and EU regulators can utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical and active pharmaceutical ingredient manufacturing facilities. In addition to lower costs and reducing duplication of inspections, the agreement will allow regulators to devote more resources to other parts of the world where there may be greater risk.¹ “The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said FDA associate commissioner for global regulatory policy, Dara Corrigan.

The FDA and the European Medicines Agency (EMA) were collaborating since May 2014 on evaluating how they each inspect drug manufacturers and assess the risks and benefits of mutual recognition of drug inspections. The FDA observed 14 of the EU’s Joint Audit Programme, a cooperative evaluation in which 2 EU nations audit the regulatory authority of another EU country and will be observing more this year. The EMA has mutual recognition GMP agreements in place with several countries including Switzerland, Japan, and Canada.

The mutual recognition agreement was originally part of the Transatlantic Trade and Investment Partnership discussions conducted under President Barack Obama.² A major point of negotiation for both the FDA and EMA was the question of trade secret information because inspections usually involve specifications of manufacturing equipment and processes that are proprietary.

The text of the mutual recognition agreement is available here.

References

1. Brennan Z. US and EU forge landmark agreement to mutually recognize drug manufacturing inspections. Regulatory Affairs Professionals Society website. http://www.raps.org/Regulatory-Focus/News/2017/03/02/27001/US-and-EU-Forge-Landmark-Agreement-to-Mutually-Recognize-Drug-Manufacturing-Inspections/. Published March 2, 2017. Accessed March 2, 2017.
2. Brennan Z. Updated: TTIP on thin ice not likely to delay US-EU mutual GMP recognition deal. Regulatory Affairs Professionals Society website. http://raps.org/Regulatory-Focus/News/2017/02/22/26936/Updated-TTIP-on-Thin-Ice-Not-Likely-to-Delay-US-EU-Mutual-GMP-Recognition-Deal/. Published February 22, 2017. Accessed March 2, 2017.