The European Medicines Agency's (EMA) Committee for Veterinary Medicinal Products (CVMP) has issued several positive opinions regarding new veterinary medicines and updated guidelines, marking significant advancements in animal health. These decisions, made during the committee's recent meetings, address a range of diseases affecting various animal species and aim to streamline the development and approval processes for veterinary vaccines.
Approvals for Novel Veterinary Products
Among the key highlights is the positive opinion for Icthiovac ERM, a vaccine developed by Laboratorios Hipra, S.A. This vaccine is designed to actively immunize Atlantic salmon fry against serotypes O1 and O2 of Yersinia ruckeri, a bacterium responsible for significant mortality in freshwater aquaculture. The approval of Icthiovac ERM represents a crucial step in preventing and controlling enteric redmouth disease in farmed salmon populations.
Another notable approval is Poulvac Procerta HVT-IBD-ND from Zoetis Belgium, a vaccine targeting multiple diseases in chickens. This vaccine aims to reduce mortality, clinical signs, and lesions associated with Marek’s disease (MD) virus, infectious bursal disease (IBD) virus, and Newcastle disease (ND) virus. By providing protection against these three major poultry diseases, Poulvac Procerta HVT-IBD-ND offers a comprehensive solution for poultry farmers.
The CVMP also granted a positive opinion for Tolfenamic acid VMD, a product from VMD N.V., intended for use in multiple animal species. This medication is indicated for the treatment of pneumonia and acute mastitis in cattle, as an adjunct treatment for metritis mastitis agalactia syndrome in pigs, for symptomatic relief of inflammatory and painful conditions in dogs, and for treating febrile syndromes in cats. Tolfenamic acid VMD provides veterinarians with a versatile tool for managing a variety of common ailments in both livestock and companion animals.
Advancing Vaccine Development
In a move to accelerate the development and approval of new veterinary vaccines, the CVMP certified two vaccine platform technology master files (vPTMFs). The first, from Zoetis Belgium, is based on a turkey herpesvirus platform (vHVT013-69 backbone vector) and was reviewed alongside the application for Poulvac Procerta HVT-IBD-ND. The second, from Intervet International B.V., utilizes a similar turkey herpesvirus platform already employed in approved chicken vaccines. This vPTMF scheme is expected to streamline the regulatory process for novel vaccines in the EU.
Guideline Updates and Regulatory Changes
The CVMP has been actively updating guidelines and regulations to align with current scientific knowledge and regulatory frameworks. A revised guideline on assessing environmental and human health risks of veterinary medicinal products in groundwater was adopted, incorporating editorial amendments to align with updated guidance and improve clarity.
Additionally, the committee adopted a guideline on stability testing for variations for veterinary medicinal products (EMA/CVMP/QWP/515653/2023) and the overview of comments (EMA/CVMP/QWP/416589/2024) following the close of the public consultation. This document provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation for veterinary medicinal products. The guideline applies to both variations not requiring assessment (VNRA) and variations requiring assessment (VRA).
Furthermore, the CVMP adopted a revision of the guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/248499/2007 – Rev.1) and the overview of comments following the close of the public consultation (EMA/CVMP/307496/2024). This revised guideline will replace the 'Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products' and has been updated primarily to align with the regulatory and scientific framework provided by Regulation (EU) 2019/6, as well as to take account of experience gained over the years in the pre- and post-authorisation assessment of veterinary medicinal products.
The committee also adopted the updated English QRD template v.9.1. The main purpose of updating the QRD template to version 9.1 is to align with the requirements of the Commission Delegated Regulation for products for oral administration (Regulation (EU) 2024/1159), Commission Implementing Regulation adopting a list of abbreviations and pictograms (Regulation (EU) 2024/875) and Commission Implementing Regulation adopting uniform rules on the size of small immediate packaging (Regulation (EU) 2024/878). The template will be implemented once the translations in all EU languages are available.
These updates reflect the CVMP's commitment to ensuring the safety, efficacy, and quality of veterinary medicinal products in the European Union.
