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

Year: 2025

Type: other

Abstract: 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 ex...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/13xyg

Author: Vroby

Language: English

Topic: SARS-CoV-2 and COVID-19 Research

Subfield: Infectious Diseases

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6973897662

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