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
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Trastuzumab-dkst Shows Promising Results in Real-World Setting for HER2+ Breast Cancer
July 9th 2024A Brazilian real-world study found trastuzumab-dkst to be an effective and safe adjuvant therapy for HER2-positive (HER2+) breast cancer, with clinical outcomes comparable to reference trastuzumab.