FDA and European Union Extend Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections to Animal Drugs

FDA and European Union Extend Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections to Animal Drugs

June 2, 2023, Covington Alert

On May 31, 2023, FDA and the European Union announced their decision to include inspection of animal drug manufacturing facilities in the U.S.-EU Mutual Recognition Agreement (MRA). A mutual recognition agreement is between two or more parties to recognize a specific regulatory process in the other country. The MRA, which entered into force in November 2017, previously only covered manufacturing of pharmaceuticals intended for human use. By extending coverage to animal drug manufacturers, FDA will be able to rely on inspection reports created by certain European authorities—minimizing the need for additional animal drug facility inspections and freeing up regulatory resources. The MRA extends only to surveillance inspections of drug establishments, not to pre-approval inspections.

FDA describes the expansion of the MRA to cover animal drug manufacturing as an important first step toward more cooperation. Although the MRA is between the United States and European Union, full regulatory recognition can only occur after FDA determines that an EU member state has the capacity to conduct inspections of animal drug facilities that meet U.S. requirements. In preparation for the expansion of the MRA to animal drugs, FDA has been observing EU audits of individual member states and analyzing their regulatory frameworks. In connection with the release of the MRA, FDA announced that the following countries meet the U.S. requirements for conducting inspections of animal drug manufacturing: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia, and Spain. FDA can therefore begin sharing surveillance inspection reports concerning animal drugs with the relevant authorities in these countries.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.