FDA/EU Mutual Recognition Agreement Includes Animal Drugs

FDA to include animal drugs in EU Mutual Recognition Agreement for pharmaceutical good manufacturing practice inspections.
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FDA-approved drugs

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 relevant agencies in EU Member States to oversee the large number of facilities that manufacture animal drugs in these locations.

The U.S. Food and Drug Administration is announcing that the FDA’s Center for Veterinary Medicine (CVM) reported to the European Union (EU) and Commission (EC) during the December 2019 Joint Sectoral Committee meeting of CVM’s decision to include veterinary pharmaceuticals as part of the FDA/EU Mutual Recognition Agreement (MRA) for Pharmaceutical Good Manufacturing Practice Inspections. The EU has also agreed in principle to include veterinary pharmaceuticals as part of the MRA.

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 relevant agencies in EU Member States to oversee the large number of 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 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.

Over the past year and a half, CVM has made significant contributions toward the progress of the MRA framework to include veterinary medicines. This has included sharing information with the EU about CVM’s oversight of animal drug manufacturing in the U.S., observing multiple audits and conducting initial evaluations of regulatory frameworks of EU Member States, and hosting EU-participated audits of two U.S. veterinary firms in June 2019. To fully utilize all available informational resources, CVM is also considering FDA’s experience and relevant data gathered during prior human pharmaceutical EU Member State assessments.

Going forward, CVM will continue to participate on the audits of the remaining EU member countries and begin the assessment process for all of the member states that have been audited so far. Once the FDA has completed an assessment of an EU Member State and determined that its authority is capable, the MRA may be implemented for veterinary medicines with that authority. Likewise, once the EU has completed the assessment of and determined the FDA capable for veterinary products, the MRA may be implemented for the U.S. as well. 

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