EU-US Trade and Technology Council: simpler rules for more trade in veterinary products
At the May 31 E.U.-US Trade and Technology Council meeting, the U.S. and the E.U. reached an agreement to mutually recognize the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products.
Veterinary products manufactured in the E.U. can now be exported to and marketed in the U.S. without a prior U.S. inspection of the E.U. manufacturers, and vice versa. This follows an earlier, similar decision for human medicines.
The U.S. Food and Drug Administration (FDA) has already recognized the capacity of 16 E.U. Member States to carry out pharmaceutical GMP inspections of veterinary products. At the same time, the E.U. 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 U.S. The target date for completion of the assessment of all E.U. authorities has been set for July 2024.
Stella Kyriakides, commissioner for Health and Food Safety, said in a statement that the agreement marks another step forward in trade relations between the E.U. and the U.S.
"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," she said. "As of now, the E.U. 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."
Further growing transatlantic trade
E.U.-U.S. trade in pharmaceutical products reached an impressive value of €123 billion in 2022. Bringing medicines to the market has become faster and less costly, to the benefit of public and animal health.
The new agreement reduces costs resulting from duplicative inspections. It frees capacity of E.U. 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.
Background
The E.U. and the U.S. have reached today's milestone under the Sectoral Annex for pharmaceutical GMP inspections under the Mutual Recognition Agreement (MRA).
The scope of this Sectoral Annex was extended to include veterinary products on 11 May with the E.U. and U.S. signature of the Joint Sectoral Committee Decision 2536/2023. This follows the full implementation of the MRA for human medicines in July 2019 when all E.U. competent authorities and the FDA were recognized as having an equivalent inspection system.
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