Zambia, Zimbabwe Approve Lenacapavir at Record Speed Through WHO Collaborative Process
Oluwatobi Adu 
ABUJA, Nigeria – Zambia and Zimbabwe have become the latest African countries to approve the long-acting HIV prevention medicine lenacapavir, completing their regulatory processes in record time through the World Health Organisation’s (WHO) Collaborative Registration Procedure (CRP).
The approvals announced on Monday represent a major milestone in accelerating access to next-generation HIV prevention tools across the continent. Zambia’s regulator, the Zambia Medicines Regulatory Authority (ZAMRA), approved lenacapavir tablets and injectables on 4 November 2025, completing its review in just 12 working days. Zimbabwe’s Medicines Control Authority (MCAZ) concluded its evaluation in 18 working days, positioning both countries among the fastest in the world to authorise the innovative product.
WHO said the approvals underscore the power of regulatory reliance to fast-track lifesaving innovations, particularly in low- and middle-income countries.
“As the world marks World AIDS Day, these swift approvals in multiple African countries demonstrate how WHO’s Collaborative Registration Procedure accelerates access to lifesaving medical products, while allowing national authorities to maintain full oversight and sovereignty over their decisions,” said Hiiti Silo, Unit Head of Regulation and Safety in WHO’s Regulation and Prequalification Department.
“It underlines what is possible when regulatory innovation meets urgent public health needs.”
The CRP enables national regulators to make quicker, evidence-based decisions through confidential access to WHO prequalification assessments or evaluation reports from WHO-listed authorities. With 69 countries and CARICOM now participating, the procedure has become one of the most widely used regulatory-reliance systems globally.
Lenacapavir’s approvals follow its earlier evaluation through the European Medicines Agency’s EU-Medicines for All (EU-M4all) procedure, which concluded in July 2025. That review involved regulators and experts from Kenya, Nigeria, South Africa, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe, alongside WHO.
WHO subsequently prequalified lenacapavir on 6 October 2025, making it eligible for procurement by global health agencies. On 27 October, the South African Health Products Regulatory Authority (SAHPRA) became the first African regulator to approve the product concurrently with the EU-M4all review.
Lenacapavir is the world’s first twice-yearly injectable PrEP option, requiring only two doses a year. It is designed to serve individuals who struggle with daily oral PrEP due to adherence challenges, stigma or inconsistent access to services. In July 2025, WHO issued guidance on the use of lenacapavir and on testing strategies for long-acting PrEP, setting the stage for national rollout.
About the Author
Korede Abdullah 
Oluwafunbi Bello 
Oluwafunbi Bello 