AUTHOR=Murombedzi Caroline , Chirinda Libert , Chareka Gift T. , Chirenje Z. Mike , Mgodi Nyaradzo M. 

TITLE=Efficient regulatory approval of two novel HIV prevention interventions in a resource-limited setting: experiences from Zimbabwe

JOURNAL=Frontiers in Reproductive Health

VOLUME=Volume 5 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2023.1279124

DOI=10.3389/frph.2023.1279124

ISSN=2673-3153

ABSTRACT=Despite significant progress made in HIV treatment and prevention, global burden of HIV remains unacceptably high. There is an urgent need to scale-up comprehensive HIV prevention strategies that include pre-exposure prophylaxis (PrEP). Oral PrEP is highly effective in preventing HIV acquisition when taken regularly but this remains a challenge for some at risk individuals. There is therefore a need for other HIV prevention options. The dapivirine vaginal ring (DVR) and long-acting injectable cabotegravir (CAB-LA) are novel biomedical interventions that are safe and efficacious for HIV preexposure prophylaxis as demonstrated in recently completed clinical trials. Timely roll-out and scalability of efficacious interventions depends on the registration process with the national medicines regulatory authorities. The Medicines Control Authority of Zimbabwe (MCAZ) was the first national medicines regulatory authority globally to approve the DVR in July 2021 and the first in Africa to approve CAB-LA for HIV prevention in July 2022. The regulatory review process for DVR and CAB-LA by MCAZ took 4.5 months and 5.5 months respectively. Thise efficient review process of the two interventions by MCAZ, a regulatory body in a resource-limited setting, provides important lessons to shorten timelines between completion of the clinical development process and registration of essential medicines.