The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines.
Originally published in June 2020, the package now includes a further 17 texts on analytical methods which are referenced in the recently released EDQM document on recombinant viral vectored vaccines for human use, but are not restricted to this technology and may also be relevant for COVID-19 vaccines based on other technologies.
This initiative was taken to support COVID-19 vaccine developers in designing appropriate analytical strategies for their candidate vaccines and to help ensure the quality and safety of final products. The application of the package’s quality requirements may ultimately help facilitate regulatory acceptance of subsequent marketing authorisation applications, thus contributing to protecting public health.
The updated Ph. Eur. vaccines package can be downloaded for free.
- EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe (June 2020)
- The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information
- European Pharmacopoeia 10th Edition
- European Pharmacopoeia Commission
- European Pharmacopoeia work programme