European Pharmacopoeia Commission Adopts First General Texts on mRNA Vaccines

In November 2024, during its 180th meeting, the European Pharmacopoeia Commission (EPC) adopted three new general texts dealing with the production and quality control of mRNA vaccines and their components. These texts are:

• mRNA vaccines for human use (5.36): This section deals with mRNA vaccines packaged in lipid nanoparticles, known as mRNA-LNP drugs.
• mRNA substances for the production of mRNA vaccines for human use (5.39): This part focuses on the active mRNA substances used in the manufacture of mRNA vaccines.
• DNA templates for the preparation of mRNA substances (5.40): This deals with the linear DNA templates that serve as starting material for the preparation of mRNA substances.

These new texts were developed through the intensive collaboration of the Ph. Eur. mRNAVAC working group, which includes experts from industry, academia, regulatory authorities and national control laboratories worldwide. The working group was established after the EDQM Nanomedicine Symposium in June 2022 with the aim of building on the ideas expressed there and taking into account the experience gained with mRNA vaccines during and after the pandemic.

The introduction of these texts aims to provide mRNA vaccine developers and manufacturers, as well as global regulatory authorities and national control laboratories, with a clear framework for the manufacture and control of mRNA vaccines. The new texts will be included in the European Pharmacopoeia in July 2025.

The EPC's decision to adopt these texts underlines the importance of standardized quality standards for mRNA vaccines, especially given their central role during the COVID-19 pandemic. By providing clear guidelines for the manufacture and quality control of mRNA vaccines, the European Pharmacopoeia is helping to ensure the safety and efficacy of these innovative therapies.

Overall, these developments represent a significant step forward in the harmonization and standardization of quality control of mRNA vaccines, which is of great benefit to both manufacturers and regulators. Read the full article on EDQM website.