Quicker processes promise turnaround times of 10-15 working days
Regulating bodies and ethics committees across the African continent have agreed to “expedite” the approval process for clinical trials related to the Covid-19 epidemic.
These will focus on “new multinational preventive, diagnostic and therapeutic interventions to the Covid-19 pandemic”, the African Union Development Agency said in a statement. ADUA on 21 April announced the outcomes of an earlier meeting between the World Health Organization and the African Vaccines Regulatory Forum, of which ADUA is part.
“A timeline of 10 working days is suggested 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,” the parties resolved.
AVAREF is composed of regulatory bodies in each region of the continent and headed by Wiltshire Johnson, who is the head of Sierra Leone’s medical regulatory agency.
The agencies also promised to share clinical trial information with each other and conduct joint Covid-19 clinical trial reviews. This will save time because regulatory and ethics review for multi-country trials will be done concurrently, which will limit “inefficiencies and delays in providing a final response to the sponsor”.
Countries’ specific clinical requirements will remain, however, to prevent a “top-down approach” to greenlighting Covid-19 trials.