European Pharmacopoeia Adopts New Standards for mRNA Vaccines

At its 180th meeting in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts to guide the production and quality control of mRNA vaccines. These include:

• 5.36: mRNA vaccines packaged in lipid nanoparticles (mRNA-LNP drugs)
• 5.39: Active mRNA substances used in vaccine manufacturing
• 5.40: Linear DNA templates used to produce mRNA substances

Developed by the Ph. Eur. mRNAVAC working group, these standards reflect insights gained during the COVID-19 pandemic and were driven by global collaboration across industry, academia, and regulatory agencies.

Set to enter into force in July 2025, the new texts offer manufacturers and regulators a unified framework to ensure safety, efficacy, and quality of mRNA vaccines.

This move marks a major step in harmonizing international standards for next-gen vaccine development and oversight.

04-04-2025