EMA news: Developing a guideline on quality aspects of mRNA vaccines

The European Medicines Agency has published for public consultation a concept paper on the development of a guideline on the quality aspects of mRNA vaccines.

This concept paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. The number of clinical trial applications for human products and marketing authorisation applications for mRNA-containing products significantly increased over the last few years and is expected to increase further in the future. Furthermore, a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. From an analytical and regulatory perspective, mRNA vaccines are interesting since their classification depends on the target and/or whether they are obtained chemically or biologically.

Comments should be provided using the EU Survey form by 30 September 2023.

Read the concept paper here.

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