U.S. and EU Expand Mutual Recognition Agreement to Include Animal Drugs

Sites making animal drugs need to be inspection-ready, as a single inspection report can now be relied upon by regulators in both the U.S. and some EU member states. Multi-jurisdictional regulatory actions could ensue. Christopher Fanelli, Chris Boyle and Yuzhi Hu explain.

The U.S. Food and Drug Administration (FDA) and the European Union (EU) has broadened the scope of the U.S.-EU Mutual Recognition Agreement (the MRA) to encompass inspections of veterinary pharmaceuticals, or “animal drugs”. One important result of this change is the increased sharing of information between the FDA and the regulatory authorities in individual EU member states for animal drug manufacturing sites, including inspection results and related information. An additional important result is that inspections of animal drug manufacturing sites will be mutually recognized in both the U.S. and the EU.

The regulators hope that the expansion of the MRA to include animal drugs will bolster animal drug inspection expertise and resources, and that allowing mutual recognition of inspections will lead to a more efficient use of inspection resources.

We anticipate that it will increase open dialogue and collaboration between the FDA and the EU regulators, allowing them to learn from each other’s best practices and update their collective standards and inspectional processes. It also means that – once the FDA recognizes the capability of all EU member states to perform animal drug good manufacturing practice (GMP) inspections – U.S. manufacturers will be able to export animal drugs to the EU, without those products having to undergo duplicate batch testing procedures to comply with EU requirements, reducing costs and administration.

The FDA’s recognition of all 27 EU member states is not expected to be fully operational until at least 2024; so far the agency has only recognized the capability of 16 EU member states to carry out GMP inspections for animal drugs at a level equivalent to the U.S. Work is continuing to achieve recognition of this capability in the remaining 11 EU member states. In the meantime, the EU has already recognized the FDA as an equivalent authority for GMP inspections of sites manufacturing animal drugs.

While we are optimistic that the expansion of the MRA to animal drugs could lead to a more efficient allocation of inspection resources, this does not mean that FDA investigators will never inspect an animal drug manufacturer in the EU, or vice versa. As with human drugs, both the FDA and the EU will retain the right to inspect at any time and in any country. The FDA and EU will also make their decisions on the need for any enforcement action independently.

This expansion of the MRA means that it will be vital to keep sites in a state of inspection readiness to ensure that inspections are passed with expedience, as a single inspection report could be relied upon by regulators in both the U.S. and the EU.

Manufacturers are also likely to find themselves at increased risk of regulatory actions by multiple jurisdictions stemming from a single inspection. Although the FDA and the EU regulators will continue to be free to take independent actions, we often see the FDA and the EU health authorities coordinate their inspections in relation to human drugs, and we anticipate similar coordination will occur in the future in relation to animal drug inspections. Animal drug manufacturers should therefore take steps to assess the inspection readiness of their critical sites, high-risk sites, and sites that are overdue for inspection.

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