Regulatory Advisory Group (RAG) Description: The RAG has members from Regulatory Agencies covering all WHO regions, including Argentina, Australia, Brazil, Canada, Europe (EMA & EDQM), AVAREF, Japan, Singapore and USA.
COVAX supports vaccine developers on general matters related to vaccine development. COVAX SWAT teams have been established for manufacturing, clinical development/operations and enabling sciences to support vaccine developers in solving product agnostic challenges in COVID-19 vaccine development. The SWAT teams have members from various stakeholders such as BMGF, WHO, GAVI and industry organizations (IFPMA and DCVMN).
The RAG was set up to give feedback on regulatory science questions of an agnostic nature raised by the COVAX SWAT teams in order to support and promote ongoing regulatory development among COVID-19 vaccine developers to ensure access when scientifically appropriate.
Feedback from the RAG will be communicated directly back to the COVAX SWAT teams, as well as presented in the format of Q&As for the benefit of all COVID-19 vaccine developers.
The outcome of the RAG in the form of Q&As is also intended to inform the wider community of Regulatory Authorities of questions and challenges vaccine developers are facing in the development of COVID-19 vaccines.
Co-Leads: Debra Yeskey and Svein Rune Andersen (CEPI Regulatory), Emer Cooke (WHO)
Q&As developed by the COVAX Regulatory Advisory Group:
The RAG applies the Chatham House rules, but divergent views will be reported as such without attribution in the Q&As.
The Q&As will be expanded when new questions are discussed or amended when updates on existing topics are available.
Major Pharmacopoeias support developers of COVID-19 vaccine and therapies:
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
EDQM is the home of the European Pharmacopoeia and an important stakeholder in the European regulatory ecosystem.
USP is supporting scientists, developers and manufacturers working worldwide to accelerate the development of safe and effective COVID-19 vaccines, medicines and other treatments. Free USP technical expertise and resources to support an efficient path for regulatory predictability has been available here.
Labelling of COVID-19 vaccines:
The European Commission has published a high level document on requirements for labelling of COVID-19 vaccines.