Europe – EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe

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…