National regulatory authorities and national ethics committees from across Africa agreed to combine their expertise to expedite clinical trial review and approvals for new multinational preventive, diagnostic and therapeutic interventions to the COVID-19 pandemic.
Through the leadership of WHO, the meeting was convened where the agreement was reached under the platform of the African Vaccines Regulatory Forum (AVAREF), one of the Continental Technical Committees of the African Medicines Regulatory Harmonization Initiative.
The aggressive timeline suggests that it will take 10 working days for processing of clinical trial applications via the joint review pathway where the product is already registered for other indications, and 15 working days for novel products.