Veterinary medicines
In 2023, EMA’s work across the veterinary medicines lifecycle helped to guide innovative treatments to market that protect and prevent the transmission of diseases in the EU. The Agency supports developers at every stage of the veterinary medicines development: helping to boost innovation and research by offering expertise before, during and after marketing authorisation. This begins at the earliest stage of the medicine development process and continues throughout the lifecycle of the medicine.
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. This aims to facilitate the development and availability of high-quality, effective and acceptably safe medicines. In 2023, EMA received 17 requests for scientific advice and finalised 24. Almost a quarter of the finalised scientific advice requests were for immunologicals, 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 AMR.
In 2023, there was continued strong interest in early engagement with EMA by companies developing medicines for small markets in the EU. The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) introduced a specific authorisation route for medicines intended for veterinary limited markets in the EU when it became applicable on 28 January 2022. It enables the CVMP to recommend granting a marketing authorisation for such medicines based on less comprehensive data than normally required, where the benefit for animal or public health of placing the medicine on the market is greater than the inherent risk of a reduced data package on the medicine. The Regulation aims to further stimulate the development of veterinary medicines for small markets, in order to increase the availability of treatments for serious or life-threatening animal diseases and unmet veterinary medical needs.
Recommendations for marketing authorisation
Applications for initial evaluation
The initial evaluation phase covers activities relating to the processing of marketing authorisation applications for veterinary medicines, ranging 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 25 applications were received in 2023, an increase of 14 % compared to 2022. Approximately half of these applications were submitted for vaccines, 11 of which were for use in food-producing animals.
Recommendations for authorisation
In 2023, EMA recommended 14 veterinary medicines for marketing authorisation. Of these, nine had a new active substance which had not previously been authorised in the EU – a threefold increase compared to 2022. Among the 14 medicines recommended for marketing authorisation, nine were vaccines, six of which had been developed by means of a biotechnological process. This demonstrates the animal health industry’s continued strong interest in innovation and developing vaccines.
| Product name | New active substance | Cattle | Cats | Chickens | Dogs | Rabbits |
|---|---|---|---|---|---|---|
| Bovilis Cryptium | ● | ● | ||||
| Bovilis Nasalgen-C | ● | ● | ||||
| Eluracat | ● | ● | ||||
| Eurican L4 | ● | ● | ||||
| Innovax-ILT-IBD | ● | ● | ||||
| Loxitab | ● | |||||
| Newflend ND H9 | ● | ● | ||||
| Nobivac LoVo L4 | ● | |||||
| Oxmax | ● | ● | ||||
| Poulvac Procerta HVT-IBD | ||||||
| Prevexxion RN+HVT | ||||||
| Prolevare | ● | |||||
| Senvelgo | ● | ● | ||||
| YURVAC RHD | ● | ● |
The average number of days taken for initial evaluations increased compared to previous years, mostly due to longer clock-stops taken by the companies to respond to questions from CVMP.
Post-authorisation activities
Post-authorisation activities relate to variations, extensions and transfers of marketing authorisations.
The use of an already-authorised medicine in a new species or a new indication offers new treatment opportunities. The use of eight known products was expanded in 2023.
Safety monitoring of medicines
Pharmacovigilance covers activities related to the detection, reporting, assessment, understanding and prevention of adverse events (AEs) 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 both serious and non-serious AE reports. In 2023, the overall number of AE reports received in the EudraVigilance system was slightly lower than 2022, when a backlog of reports was submitted by marketing authorisation holders.