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EDQM Offers Free Access to European Quality Standards for COVID-19 Vaccine Developers
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.
EDQM revealed in a June 8, 2020 press release, that the selection of quality standards for vaccines, including those for viral vaccines, is available for free on a temporary basis online. The package of standards that are available will be regularly reviewed and updated.
Developers accessing the quality standards will be able to build in the appropriate analytical control strategies for the COVID-19 vaccines under development and ultimately ensure the quality and safety of final products. Additionally, application of the quality standards may aid in expediting regulatory acceptance of a marketing authorization application.