AVAREF in the News
The Global Health Regulatory Team (GHRT) Regulatory Update – September 2020
In 2019, the AVAREF Assembly adopted a new governance structure to align with the African Medicines Regulatory Harmonization (AMRH) Initiative. This new structure transformed AVAREF’s Technical Coordination Committee into a Continental Working Group, and the AVAREF Steering Committee was re-established as an Advisory Committee to provide strategic guidance for the Working Group Committees.
AVAREF is in the process of implementing this new governance structure. A detailed description of these bodies is provided below.
Country and Regional Regulatory Updates:
Africa
AVAREF developed a series of webinars to facilitate harmonization of the review and processing of COVID-19 applications. The webinars included speakers from WHO Regional Office for Africa, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), and the Coalition for Epidemic Preparedness Innovations (CEPI), among others. Topics ranged from AVAREF review tools and processes to lessons learned about vaccine manufacturing in Africa from COVID-19. The webinar series was originally developed for regulatory agencies and ethics committees of AVAREF’s 55 African Member States; 11 webinars are now available for the public to view online.
AVAREF also released a case study, highlighting the best practices employed by the Kenyan Pharmacy and Poisons Board (PPB) to support research and speed review of clinical trials for COVID-19-related products. These best practices include, but are not limited to, measures such as enabling online application submissions and allowing parallel submission of applications to the PPB and other reviewing authorities to cut down the review period timeline. Using these best practices, the PPB decreased review times to less than 10 days. To ensure timely reviews moving forward, PPB advises clinical trial sponsors to adhere to all requirements listed on the PPB Clinical Trials website, take advantage of pre-submission meetings to resolve any questions or gaps in data, and study country-specific addenda for any international products.
AVAREF Press Release on Expedited Joint Reviews of CTAs (April 2020)
In a meeting convened by WHO on 1 April 2020, under the platform of AVAREF, national regulatory authorities (NRAs) and national ethics committees (ECs) from across Africa agreed to combine their expertise to expedite clinical trial review and approvals for new multinational preventive, diagnostic and therapeutic interventions to address the COVID-19 pandemic. As per the agreement, joint reviews are based on voluntary cooperation between the NRAs and ECs, and each country is solely responsible for granting regulatory approval.
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