Free Access to Supportive Pharmacopoeial Texts in the Field of COVID-19 Vaccines Is Open

07 December 2020

GMP News

The EDQM is committed to supporting users 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 providing access to relevant guidance/standards.

To support organisations involved in the development, manufacture or testing of COVID-19 vaccines worldwide, many of which are universities and small and medium-sized enterprises, the EDQM is offering temporary free access to texts of the European Pharmacopoeia (Ph. Eur.) in the field of vaccines.

This package includes quality standards for vaccines which developers can take into account to help build appropriate analytical control strategies for their COVID-19 candidate vaccines and 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.

For ease of reading, a summary table listing the pharmacopoeial texts, with information regarding the vaccine types or vaccine platforms concerned (e.g. live attenuated viral vaccine, recombinant viral-vectored vaccines) is provided. The list of texts is not exhaustive and will be reviewed regularly and updated as required.

The pharmacopoeial texts comprise overarching general texts (general notices, general monographs, dosage form monographs and general chapters) as well as selected individual vaccine monographs and analytical methods. The texts are from the 10th Edition of the Ph. Eur., including Supplement 10.4.




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