EU, US to simplify rules for more trade in veterinary productsEU, US to simplify rules for more trade in veterinary products
Ensures a more efficient process in making high quality medicines available for the benefit of animal health on both sides of the Atlantic.
June 1, 2023
During this week's EU-US Trade and Technology Council, the U.S. Food and Drug Administration and the European Union reached an agreement to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices to include inspections of veterinary pharmaceuticals. This means that veterinary products manufactured in the EU can now be exported to and marketed in the United States without a prior U.S. inspection of the EU manufacturers, and vice versa.
The MRA entered into force on November 1, 2017, 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 EU regulatory systems," the FDA said.
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 EU to oversee the facilities that manufacture animal drugs.
"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," the FDA explained.
"Transatlantic trade in pharmaceutical products reached an impressive €123 billion last year," said European Executive Vice-President and Commissioner for Trade Valdis Dombrovskis. "Thanks to the platform provided by our joint Trade and Technology Council, we have reached an agreement to simplify rules for trade in veterinary products. This will unlock more opportunities on both sides of the Atlantic, by making trade in this important sector cheaper and faster, so that the public can benefit – and animals too."
The FDA has already recognized the capacity of 16 EU Member States to carry out pharmaceutical GMP inspections of veterinary products. At the same time, the EU has recognized the FDA as an equivalent authority to carry out these inspections. The U.S. assessment of the remaining competent authorities of the Member States continues according to a schedule agreed with the United States. The target date for completion of the assessment of all EU authorities has been set for July 2024.
"Today's agreement is another step forward in the trade relations between the EU and the U.S.," said European Commissioner for Health and Food Safety Stella Kyriakides. "It will ensure a more efficient process in making high quality medicines available for the benefit of animal health on both sides of the Atlantic. As of now, the EU and the U.S. will no longer need to duplicate inspections. This will save both costs and precious time, and it will enable us to focus our efforts on other countries where inspections are more important to maintain the highest possible safety standards.
The agreement reduces costs resulting from duplicative inspections. It also frees capacity of EU and U.S. authorities to focus on inspections of higher risk manufacturers in other countries.
Building on today's success, the two sides have also started discussions on a decision to possibly extend the scope of the agreement to human vaccines and plasma-derived medicinal products.
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