The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards.
The EDQM and the Ph. Eur. have therefore decided to share Ph. Eur. quality standards for vaccines in order to support vaccine developers (many of which are universities and small and medium-sized enterprises) in designing appropriate analytical strategies for their candidate vaccines and to help ensure the quality and safety of the final product. Application of such quality requirements may ultimately help to facilitate regulatory acceptance of a subsequent marketing authorisation application.
The selection of quality standards for vaccines is temporarily available to the public in a freely accessible database on the EDQM website and will be regularly reviewed and updated as deemed appropriate.
Read more in the press release.