The U.S. Food and Drug Administration and the European Union are expanding their Mutual Recognition Agreement’s (MRA) Sectoral Annex for Pharmaceuticals Good Manufacturing Practices to include veterinary pharmaceuticals.
An MRA is an arrangement between two or more countries to acknowledge a specific process or procedure. The initial U.S. and EU MRA went into effect November 1, 2017, and included only pharmaceuticals intended for human use.
Expanding the scope to include veterinary pharmaceuticals is intended to:
- Strengthen animal drug inspection expertise and resources in each country
- Produce greater efficiencies for the U.S. and EU regulatory systems
- Provide more practical means for the FDA and EU to oversee the facilities that manufacture animal drugs
- Enable regulators to devote more resources to high-risk areas
Each of the EU’s 27 countries has its own regulatory authority. While the regulatory guidelines and legal requirements exist at the EU level, individual countries have the discretion to implement the law how it best suits them.
On May 30, 2023, the FDA completed capability assessments for 16 EU veterinary drug regulatory authorities. The MRA text defines a capable regulatory authority as one that:
- Has the legal and regulatory authority to inspect for Good Manufacturing Practice standards
- Ethically manages conflicts of interest
- Appropriately oversees manufacturing facilities in its territory
- Receives and utilizes adequate resources
- Employs trained and qualified inspectors who have the skills and knowledge to identify potentially harmful manufacturing practices
- Possesses the necessary tools to protect the public from poor-quality drugs or medicinal products
In addition to conducting capability assessments, the FDA has prepared for the MRA expansion by sharing information with the EU about the FDA’s Center for Veterinary Medicine’s oversight of animal drug manufacturing in the U.S. and observing EU audits of individual member states.
As a result of Brexit, the U.K. was no longer a part of the U.S.-EU MRA, and an MRA with the U.K., which includes human and veterinary drugs, was entered into force on January 1, 2021. In addition, on January 12, 2023, the FDA signed an MRA with Switzerland that covers human and veterinary drugs. Before this MRA enters into force, the FDA must determine Switzerland’s capability of conducting U.S.-sanctioned inspections, and the Swiss Agency for Therapeutic Products (Swissmedic) must make a similar assessment regarding the FDA.