Published on 01/12/2025
Zambia Medicines Regulatory Authority (ZAMRA) has approved lenacapavir tablets and injectable formulations for HIV prevention, granting authorization on 4 November 2025 after just 12 working days of review.
The decision was made using the WHO Listed Authorities (WLA) Collaborative Registration Procedure (CRP), a reliance-based pathway that enables countries to make fast, informed decisions by leveraging assessments from trusted regulatory authorities or WHO prequalification.
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Shortly afterward, Zimbabwe’s Medicines Control Authority (MCAZ) also approved the product, completing its review in 18 working days.
These rapid authorizations underscore the potential of regulatory reliance as a powerful model for accelerating access to innovative health products. Timed with World AIDS Day 2025, they offer a promising path to halting new HIV infections by rapidly opening doors to next-generation prevention options across Africa.
“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 Regulation and Prequalification Department. “It underlines what is possible when regulatory innovation meets urgent public health needs.”
A faster pathway to access
WHO CRP is a regulatory reliance mechanism that allows national regulators to make evidence-based decisions faster by using assessments already conducted by trusted regulatory bodies. Under the CRP, countries receive – through confidentiality agreements – technical assessment and inspection reports from either WHO Prequalification or WHO Listed Authorities. This approach avoids duplicate regulatory work, saves time and resources, and supports sovereign national decision-making while accelerating access to quality-assured medicines and vaccines. To date, 69 countries and one Regional Economic Community (CARICOM) participate in WHO CRP globally.
Lenacapavir’s evaluation under the European Medicines Agency (EMA)’s EU-Medicines for All (EU-M4all) procedure, issued in July 2025, served as the reference for the CRP. EU‑M4all combines EMA expertise with input from non-EU regulators and WHO to evaluate medicines for use outside the European Union. Experts from WHO and regulatory authorities in Kenya, Nigeria, South Africa, Thailand, Uganda, Vietnam, Zambia and Zimbabwe, and contributed to the assessment providing a thorough, collaborative review that informed rapid approvals.
WHO prequalified lenacapavir on 6 October 2025 via a new abridged prequalification pathway based on reliance under the EU-M4all evaluation procedure, making it eligible for procurement by United Nations agencies, global health partners and countries.
On 27 October 2025, the South African Health Products Regulatory Authority (SAHPRA) became the first African regulatory authority to approve lenacapavir, in parallel with the EU-M4all procedure and in collaboration with EMA.
Applications in other countries through the WHO Listed Authorities CRP are ongoing, aiming to further expand access to this transformative HIV prevention option.
Lenacapavir is the first twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV, offering a highly effective, long-acting alternative to daily oral pills. With only two doses per year, it provides a practical option for people who face challenges with adherence, stigma, or limited access to healthcare.
In July 2025, WHO released guidelines on the use of lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis, paving the way for national implementation.
