FDA and United Kingdom Announce Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs
September 27, 2021
The U.S. Food and Drug Administration (FDA) and the United Kingdom’s Veterinary Medicines Directorate (VMD) are announcing today their decision to expand the scope of the U.S.-UK Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals (also called “animal drugs”). This MRA entered into force on January 1, 2021, but initially included only pharmaceuticals intended for human use. Today’s action to include animal drugs in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the U.S. and UK regulatory systems.
An MRA is an agreement between two or more countries to recognize a specific process or procedure of the other country, and this is the first step toward strengthening use of each other’s animal drug inspection expertise and resources. The overall goal of the MRA is to produce greater efficiencies for both regulatory systems and provide a more practical means for both the FDA and the VMD to oversee the facilities that manufacture animal drugs in these locations. By utilizing each other’s inspection reports and related information, an MRA can ultimately enable the FDA and VMD to avoid duplication of some animal drug inspections and enable regulators to devote more resources to other areas where there may be greater risk.
Over the past several months, the FDA has taken numerous steps to prepare for expanding and implementing the MRA’s coverage to include animal drugs. This has included, among other things, sharing information with the UK about FDA’s Center for Veterinary Medicine’s oversight of animal drug manufacturing in the U.S.; observing an audit performed by European Union auditors of an inspection that was conducted by a VMD inspector; and conducting an evaluation of the UK’s regulatory framework, which found the UK has the capability, capacity and procedures to carry out routine GMP surveillance inspections that meet FDA requirements for animal drugs.
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Issued by FDA Center for Veterinary Medicine.
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