During the April 2026 session, the European Medicines Agency’s (EMA) Committee for Veterinary Medicinal Products (CVMP) addressed a range of regulatory and scientific topics covering authorised products, pharmacovigilance, antimicrobial resistance (AMR) and ongoing guideline development.
A key area of attention of this session was the adoption of a new concept paper for a revised reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the EU, which aims to limit resistance to antimicrobials and maximise their impact on public and animal health.
The adopted concept paper outlines intended areas for revision to a reflection paper originally published in 2011. These include considerations related to the critical importance of these antimicrobial classes for human medicine, the risk of cross-resistance between MLS compounds, updated evidence on antimicrobial consumption and resistance trends, and developments at international level and on the human medicines side. It also reflects a One Health perspective, considering the potential transmission of resistance between animals, humans and the environment, and may expand its scope beyond food-producing animals to include companion animals. The draft is open for a four-month period of public consultation (with all comments to be submitted by 31 August 2026) and is expected to inform future regulatory guidance and policy development.
Quality and manufacturing considerations were also important components of the discussion. The Committee adopted the overview of comments received on the guideline on synthetic peptides, which was adopted in December 2025 and will become applicable in June 2026, and progressed revisions to the guideline on residual solvents. It also updated Q&As relating to reduced testing approaches. For regulatory affairs professionals, these developments are particularly relevant for chemistry, manufacturing and controls (CMC) strategy, as they clarify expectations around manufacturing controls, data requirements, and the justification of reduced testing in both new applications and post-authorisation changes.
The CVMP also adopted a concept paper on the development of a framework for biosimilarity for veterinary biologicals, indicating early regulatory consideration of this area and the potential for future guideline development.
Another important outcome was the conclusion of an Article 82 referral for albendazole oral suspensions for sheep. The referral was triggered by concerns that ‘authorised doses may no longer be adequate to ensure effective use… potentially contributing to the development of anthelmintic resistance.’ The Committee recommended changes to the dose and the inclusion of warnings on the effective use in the product information, while confirming that the benefit–risk balance remains favourable. This reflects a regulatory review of authorised products at EU level, which can lead to coordinated updates to product information to reflect current efficacy and safety considerations.
For regulatory affairs professionals, these developments highlight a regulatory landscape that continues to evolve across both quality and antimicrobial policy areas. Ongoing monitoring of guideline updates, reflection papers and public consultations will be important to assess potential impacts on regulatory strategies for both existing products and future development.
Professionals are advised to review the full meeting highlights from the European Medicines Agency (EMA) and track upcoming consultations to ensure that regulatory strategy stays aligned with these evolving expectations.
