Quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products

The proposed guideline addresses the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies used as veterinary medicinal products.
Regulation (EU) 2019/6 recognises RNA antisense therapy and RNA interference therapy products as novel therapies and sets out specific requirements in Annex II. The guideline aims to provide detailed requirements to support the implementation of these provisions not already covered in the general guidance documents applicable to veterinary medicinal products.

Keywords: Guideline, RNA, interference, antisense, oligonucleotide

Current version - under consultation

Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products

Draft: consultation open Consultation dates: 24/07/2026 to 31/10/2026 Reference Number: EMA/CVMP/NTWP/24800/2026 Summary:

This concept paper addresses the need for a guideline on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.

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