The French Agency for Veterinary Medicinal Products celebrates its 30th anniversary
The French Agency for Veterinary Medicinal Products (ANMV) was created in 1994. Part of ANSES, it monitors the efficacy of the veterinary medicinal products used in France and ensures they are environmentally friendly and safe for animal and human health. The ANMV’s missions and importance on the French and European scenes have changed significantly over the past 30 years. Below, Franck Fourès, Director of the ANMV, looks back at its history and discusses the major challenges that lie ahead.
What is the ANMV?
Franck Fourès: The ANMV, which is part of ANSES, has around 100 employees. Our activities are divided into three main areas: the assessment of veterinary medicinal products to authorise their placing on the market in France or the European Union; market surveillance for veterinary medicinal products, in particular to monitor adverse effects for treated animals, people who come into contact with these products, and the environment; and the authorisation of veterinary medicinal products and pharmaceutical establishments. The ANMV is also involved in drafting regulations in Europe and harmonising assessment processes for veterinary medicinal products and their residues in food at international level. Although we are a small organisation, we are also one of the few in Europe to specialise in veterinary medicinal products. The ANMV’s expertise is recognised in many fields, particularly the assessment of vaccines. Its place within ANSES gives it a broad view of animal health issues, going far beyond veterinary medicinal products. This is particularly the case for antimicrobial resistance: we take a holistic approach to this issue, in collaboration with ANSES’s assessment and expert appraisal teams, particularly those in the Agency’s research and reference laboratories. As another example, ANSES’s experts have been of great help in proposing a risk assessment method tailored to herbal veterinary medicinal products.
How has the ANMV changed since it was founded?
FF: Within the last 30 years, the ANMV has expanded from a national framework to a system that is now almost exclusively European. In 2023, we handled around 30% of the scientific assessment procedures for veterinary medicinal products filed in the European Union, which was a very large percentage considering that there are 27 Member States. This leading position in the current system for the marketing authorisation of veterinary medicinal products has led us to review our operations and develop our skills, over and above the scientific issues involved. Our teams need to be able to harness their expertise and positions to play a decisive role in European discussions on the regulation of veterinary medicinal products.
What major challenges lie ahead for the ANMV in the next few years?
FF: We are facing several challenges. How can we maintain a high level of expertise in a context where technologies are becoming increasingly complex, as are budgetary requirements? How can we support the emergence of therapies requiring regulatory frameworks that differ from those applicable to vaccines and chemical medicinal products? How can we have teams that are both specialised and sufficiently multi-skilled to deal with a wide range of medicinal products, ranging from generics to innovative therapies such as phage therapy, stem cells, and messenger RNA vaccines? If France is to remain a reference country, we must continue to reconcile rigorous assessments, independence from industry, and a strong ability to support professionals. I would also like to mention the progress that needs to be made in the fight against antimicrobial resistance and in monitoring the availability of certain veterinary medicinal products, particularly vaccines. Other issues are emerging, on which we will need to take a stand: these include the lack of a ‘medical device’ status in veterinary medicine and the regulation of diagnostic tests. Innovation remains a major challenge, and the economic context is a significant factor. The ANMV will therefore remain attentive to market developments and their impact on the assessment and authorisation of medicinal products. The use of big data, particularly for the veterinary pharmacovigilance system that we coordinate, is also a topic on which we intend to progress. These are all areas that will continue to mobilise our teams in their day-to-day work.
The ANMV’s key dates
1975: Creation of the Laboratory for Veterinary Medicinal Products in Fougères. It was responsible for assessing marketing authorisation applications for veterinary pharmaceutical products and conducting research into the quality, efficacy and safety of these products.
1988: Integration of the Laboratory for Veterinary Medicinal Products into the National Centre for Veterinary and Food Studies (CNEVA). The CNEVA would later become AFSSA and then ANSES.
1994: Creation of the French Agency for Veterinary Medicinal Products (ANMV) in response to changes in the context due to health crises and the creation of agencies in the sector of human health products. The ANMV was tasked with assessing, authorising and monitoring veterinary medicinal products. The laboratory continued to carry out its research activities. This laboratory would later become ANSES’s Fougères Laboratory.
1995: Appointment of the ANMV as a Collaborating Centre for the World Organisation for Animal Health (OIE, which became WOAH in 2022) for veterinary medicinal products.
2002: Creation of the national veterinary pharmacovigilance scheme coordinated by the ANMV.
2015: Introduction of a system for reporting stock shortages of veterinary medicinal products.
2022: Entry into force of the new European regulations on veterinary medicinal products. The ANMV took part in the work to draft these regulations and prepare for their implementation.