FDA and European Union expand Mutual Recognition Agreement to include animal drugs

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The FDA and the European Union (EU) have expanded the scope of the US-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals. Since the Sectoral Annex for Pharmaceutical GMP entered into force in 2017, it has been applicable for drugs only intended for human use. The inclusion of veterinary pharmaceuticals in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the US and EU regulatory systems, according to the FDA.¹

An MRA is an agreement between 2 or more countries to recognize a specific process or procedure of the other country. The joint decision to expand the US-EU Sectoral Annex for Pharmaceutical GMP is the first step toward strengthening use of each other’s animal drug inspection expertise and resources, according to the FDA.¹ In January 2021, the FDA entered into force an MRA with the United Kingdom that covers both human and animal drugs. The agency also signed an MRA with Switzerland, in January 2023, that covers pharmaceuticals for both human and animals; however, it is not yet entered into force.²

The overall goal of the MRA between the US and the EU is to produce greater efficiencies and provide a more practical means for both regulatory systems to oversee the facilities that manufacture veterinary pharmaceuticals. By utilizing each other’s inspection reports and related information, an MRA can ultimately enable the FDA and the EU to avoid duplication of some animal drug inspections and enable regulators to devote more resources to other areas where there may be greater risk.¹

Over the past several months, the FDA has taken numerous steps to prepare for expanding and implementing the MRA’s coverage to include veterinary pharmaceuticals. Coverage now includes the sharing of information with the EU about FDA’s Center for Veterinary Medicine’s oversight of animal drug manufacturing in the US, observing EU audits of individual member states, and conducting assessments of some EU member states’ regulatory frameworks.¹

The MRA assessment process for veterinary pharmaceuticals is a the same as that for human drugs.2 Assessments for the US-EU agreement have already identified some member states with the capability, capacity, and procedures to carry out routine GMP surveillance inspections that meet FDA requirements for animal drugs.¹

References

1. FDA and European Union Announce Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice inspections of animal drugs. News release. FDA Center for Veterinary Medicine. May 31, 2023. Accessed May 31, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-and-european-union-announce-mutual-recognition-agreement-pharmaceutical-good-manufacturing?utm_medium=email&utm_source=govdelivery
2. US-EU Mutual Recognition Agreement/frequently asked questions and answers. May 2023. Accessed May 31, 2023. https://www.fda.gov/media/168700/download