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Portal Veterinary medicinal products
ANSES inspections for veterinary medicines recognised by US FDA
On 30 May 2023, the European Union (EU) and the United States made significant progress towards mutual recognition of inspections of manufacturers of chemical veterinary medicinal products.
The Food and Drug Administration (FDA) has recognised the ability of 16 EU member states to carry out Good Manufacturing Practice (GMP) inspections for veterinary chemicals at a level equivalent to that of the United States. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of veterinary drug manufacturing sites. Of these 16 Member States whose GMP inspections for veterinary medicinal products are recognised, France, represented by ANSES, is a member of Bulgaria, Hungary, the Netherlands and Portugal of the first 5 competent strictly veterinary authorities. This progress builds on the successful implementation of the Mutual Recognition Agreement (MRA) for medicinal products for human use since 1 November 2017.
Now, the FDA, instead of duplicate inspections, will be able to rely on inspections carried out by these 16 Member States also for veterinary products and vice versa EU Member States and the European Medicines Agency (EMA) will rely on FDA inspections. However, this agreement does not concern vaccine manufacturers. The benefits of the MRA for EU authorities and the FDA include the possibility of focusing inspection resources on other parts of the world where active pharmaceutical ingredients and drugs destined for EU or US markets are manufactured and to strengthen inspections of drug manufacturing sites for high-risk cases. For pharmaceutical manufacturers, including small producers, this agreement reduces the administrative burden and costs of inspections that could previously be doubled.
Please note that the end of the obligation to control each batch of imported veterinary medicinal product, set out in Article 9 of the Sectoral Annex on GMP of the MRA, will only come into force once the FDA has recognised all national competent EU authorities responsible for veterinary medicinal products.
The teams of the European Commission (EC), the national competent authorities of the EU, the EMA and the FDA continue to work closely together to ensure the timely evaluation of the remaining 11 competent authorities of the Member States.
- For more information, see the EMA information