EMA - Concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use.

15th January 2025

EMA - Concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use.

The European Medicines Agency has published for public consultation a Concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use.
This concept paper addresses the need to establish a Guideline on the quality aspects of mRNA vaccines. In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. It is expected that such developments will be seen in the field of vaccines for veterinary use, too. The scope of the guideline will be limited to mRNA vaccines against infectious diseases (including self-amplifying mRNA).

Comments should be sent to vet-guidelines@ema.europa.eu by 8 April 2025 using this template.

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