At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of mRNA vaccines and their components, namely:

• mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, i.e. mRNA-LNP medicinal products;
• mRNA substances for the production of mRNA vaccines for human use (5.39), covering mRNA active substances used in the manufacture of mRNA vaccines;
• DNA templates for the preparation of mRNA substances (5.40), covering the linear DNA template used as starting material for the preparation of mRNA substances.

This new series of European Pharmacopoeia (Ph. Eur.) texts on mRNA vaccines is the result of the collaborative work and active engagement of the Ph. Eur.’s mRNAVAC Working Party – a large and dynamic group comprising specialists representing industry, academia, licensing authorities and national control laboratories from around the world.

The mRNAVAC Working Party was established in the wake of the EDQM Nanomedicines symposium held in June 2022 to build on stakeholders’ ideas put forward at the event and to take into account the experience gained with mRNA vaccines both during and after the pandemic. Since its establishment, the Working Party has worked intensively, resulting in the elaboration of the three new texts in record time, an achievement made possible through close collaboration and the commitment of the experts.

The new Ph. Eur. texts will support developers and manufacturers of these novel products, but also the regulatory agencies and national control laboratories worldwide that regulate them, by providing a framework of requirements for the production and control of mRNA vaccines. The new texts will be published in the Ph. Eur. in July 2025.