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 ex...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-05-16
DOI
https://doi.org/10.58079/13xyg
Primary Topic
Molecular Biology Techniques and Applications
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Industrias Culturais (Universidade de Coimbra)
Molecular Biology Techniques and Applications
article

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

article en

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...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 52%
Molecular Biology Techniques and Applications
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.

EMA – Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS