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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) |
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Technical Briefs 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 Technical Briefs.
Access Technical Briefs here.
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. 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. |
Packaging and labelling of COVID-19 Vaccines:
WHO has published working position on model packaging for COVID-19 vaccines.
The European Commission has published a high level document on requirements for labelling of COVID-19 vaccines.
Meetings: FDA VRBPAC meeting on COVID-19 on 22 October
WHO Regulatory Updates on COVID-19 | WHO publish considerations on evaluation of COVID-19 vaccines after public consultation
WHO publishes principles on implementing efficient and effective authority lot release of COVID-19 vaccines: WHO Operational Tool for efficient and effective lot release of SARS-CoV-2 (Covid-19) vaccinesNEW | WHO Model NRA/NCL Lot Release Certificate for SARS-CoV-2 (Covid-19) vaccinesNEW
EMA safety monitoring plan and guidance on risk management planning for COVID-19 vaccines | EMA considerations on COVID-19 vaccine approval
RAG Meetings Q&As
2021: May - April - March (no meeting) - February - January
2020: December (no meeting) - November - October - September - August