In today’s EU-US Trade and Technology Council, the US and the EU reached an agreement to mutually recognise the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products. This means that veterinary products manufactured in the EU can now be exported to and marketed in the US without a prior US inspection of the EU manufacturers, and vice versa. This follows an earlier, similar decision for human medicines. The US Food and Drug Administration (FDA) has already recognised the capacity of 16 EU Member States to carry out pharmaceutical GMP inspections of veterinary products. At the same time, the EU has recognised the US FDA as an equivalent authority to carry out these inspections. The US assessment of the remaining competent authorities of the Member States continues according to a schedule agreed with the US. The target date for completion of the assessment of all EU authorities has been set for July 2024.
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, the Medicines and Healthcare products Regulatory Agency has announced today. This means that patients will have access to safe and effective medicines that have been approved by trusted regulatory partners in other countries. The new international recognition routes will sit alongside the MHRA’s own unique innovation pathway for medicines which integrates early regulatory advice with health technology assessment advice. These recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.