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EMA – Development of a guideline on the quality aspects of mRNA vaccines – Scientific guideline

The EMA is currently developing a guideline on the quality aspects of mRNA vaccines and recently published a draft version of the guideline for consultation until 30 September 2025.

It addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control of mRNA vaccines, as well as the definition of starting materials, active substance and finished product for mRNA vaccines. Additional regulatory considerations are provided for changes in existing mRNA vaccine strains, bivalent and multivalent vaccines, self-amplifying mRNA vaccines, other delivery systems and use of platform technology/prior knowledge.

More information on the dedicated page.

Templates for submission of comments and more open consultation on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (16 mai 2025). EMA – Development of a guideline on the quality aspects of mRNA vaccines – Scientific guideline. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/13xyg


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