Regulatory Advisory Group

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, UK, South Korea, India and US.  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 published here by month of the meeting and as an annotated Technical Brief on WHO’s web site for the benefit of all COVID-19 vaccine developers. In addition, these outcomes are 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: Adam Hacker (CEPI Regulatory) and Rogério Gaspar (WHO)

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.
EDQM has made written standards relevant to COVID-19 vaccines and training material available for free.

The EDQM has drafted a text on the control of viral vectored vaccines in order to support COVID-19 vaccine developers currently working on candidate vaccines based on this technology. This work was accomplished in collaboration with the European Pharmacopoeia (Ph. Eur.) Group of Experts on vaccines for human use (Group 15), which is composed of experts from licensing authorities, national control laboratories, academia and industry from Europe and beyond (including the United States Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia).

U.S. Pharmacopoeia:

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.