Veterinary medicines

In 2024, EMA's work across the veterinary medicines lifecycle helped to guide innovative treatments to market that strengthen animal health and prevent the transmission of diseases in the EU. The Agency supports developers at every stage of veterinary medicine development, helping to boost innovation and research by offering expertise before, during and after marketing authorisation.

Activities supporting research and development

Scientific advice

EMA offers scientific advice to companies on the appropriate tests and studies in the development of a veterinary medicine to facilitate the availability of high-quality, effective and acceptably safe medicines. In 2024, EMA received 27 requests for scientific advice and also finalised 27. Almost a quarter of the finalised scientific advice requests were for immunological products, including vaccines. These types of medicines play a major role in protecting animal health by preventing and controlling serious epizootic diseases. They are also important for human health because they ensure safe food supplies and prevent animal-to-human transmission of infectious diseases. In addition, veterinary vaccines can be an effective tool in reducing the need to use antibiotics in animals, thereby contributing to the fight against antimicrobial resistance.

Veterinary limited markets

In 2024, companies developing medicines for small markets in the EU showed a steady interest in early engagement with EMA. The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) has established a specific authorisation route for medicines intended for veterinary limited markets in the EU. It enables the CVMP to recommend marketing authorisations on less comprehensive data than normally required, provided the benefit for animal or public health of placing such medicines on the market is greater than the inherent risk of a reduced data package. The Regulation aims to further stimulate the development of veterinary medicines for small markets, to increase the availability of treatments for serious or life-threatening animal diseases and unmet veterinary medical needs. In 2024, EMA received 14 requests for limited market classification and four applications for initial marketing authorisation for limited market products.

Recommendations for marketing authorisation

Applications for initial evaluation

Activities in the initial evaluation phase of veterinary medicines range from pre-submission meetings with future applicants, through evaluation by the CVMP to the granting of marketing authorisation by the European Commission. A total of 27 applications were received in 2024, an increase of 8 % compared to 2023, and continuing the trend seen since the new Veterinary Medicinal Products Regulation became applicable. Approximately half of these applications were submitted for vaccines, 12 of which were for use in food-producing animals.

Recommendations for authorisation

In 2024, EMA recommended 25 veterinary medicines for marketing authorisation, the highest number of recommendations in a year. Of these, two had a new active substance that had not previously been authorised in the EU. Fourteen were vaccines, an increase of 55 % compared to 2023. Of these 14 vaccines, seven had been developed through a biotechnological process. This demonstrates the animal health industry's continued strong interest in innovation and developing vaccines.

The average number of days taken for initial authorisations has decreased considerably compared with previous years, mainly due to a significant reduction of length of clock-stops taken by the companies to respond to questions from CVMP.

Post-authorisation activities

Post-authorisation activities relate to activities such as variations and transfers of marketing authorisations.

The use of an already-authorised medicine in a new species or the addition of a new indication offers new treatment opportunities. The use of four known veterinary medicinal products was expanded in 2024.

Safety monitoringof medicines

Pharmacovigilance covers activities related to the detection, reporting, assessment, understanding and prevention of adverse events following the administration of veterinary medicines. It aims to ensure the monitoring of the safety of veterinary medicines and the effective management of risks throughout the EU.

EudraVigilance

The Veterinary Medicinal Products Regulation requires reporting of adverse events as so-called Adverse Drug Reaction Reports (ADRs). The total number of reports rebounded in 2024, approaching the 2022 level when a backlog of reports was submitted by marketing authorisation holders. While ADRs reported from outside the EU continued to grow for centrally authorised products (CAPs), that trend seemed to be reversed for medicines authorised at national level (non-CAP, non-EU ADRs).