The European Medicines Agency (EMA) has launched a public consultation on a concept paper outlining quality and safety requirements for RNA interference and RNA antisense oligonucleotide therapies used as veterinary medicinal products. The consultation, opened on 24 July 2026, seeks stakeholder feedback by 31 October 2026 to develop a dedicated guideline for these novel therapies.
The concept paper, adopted by the Committee for Veterinary Medicinal Products (CVMP) on 16 July 2026 and agreed by the Novel Therapies and Technologies Working Party (NTWP) in April 2026, addresses the need for specific guidance beyond the general requirements set out in Regulation (EU) 2019/6. That regulation recognises RNA antisense and RNA interference products as novel therapies and lays out baseline data requirements in Annex II, including the need to establish minimum RNA segment amounts per volume, confirm correct sequences, monitor degradation rates, and assess potential harmful effects such as off-target binding, pro-inflammatory responses, and central nervous system impacts.
The proposed guideline aims to provide more detailed specifications for manufacturers, covering both synthetic and recombinant production methods. It will address quality control tests, stability studies, and safety assessments for on- and off-target effects, as well as considerations for products intended for gene therapy. The initiative follows a survey among industry stakeholders that identified RNA-based therapies as a priority area for regulatory clarity.
Stakeholders affected include veterinary pharmaceutical companies, which will face new compliance requirements for marketing authorisation applications; animal health regulators in EU member states, who will need to implement the guidelines; livestock and companion animal owners, who may gain access to advanced treatments; and the broader veterinary sector, which could see innovation spurred by clearer regulatory pathways. The guideline is expected to balance innovation with safety, potentially increasing development costs for manufacturers while improving treatment options for animals.
Comments on the concept paper can be submitted via a template to vet-guidelines@ema.europa.eu until 31 October 2026. The final guideline will be developed based on feedback and adopted by the CVMP.