New OCABR vaccine guidelines to improve regulation efficiency

DNA vaccine vial concept

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One new guideline relevant to mRNA vaccines produced with LNPs and two revised guidelines for vaccines to treat infectious diseases.

Following its adoption on 1 May, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a single guideline for mRNA vaccines produced with lipid nanoparticles (LNPs), supporting regulatory consistency and efficiency.

The new guideline establishes a harmonised framework for the co-ordinated, independent control of these EU-bound vaccines. Appliable products include

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