ZAMRA approves lenacapavir for HIV prevention in record time

ZAMBIA— The Zambia Medicines Regulatory Authority (ZAMRA) has authorized lenacapavir tablets and injectable formulations for HIV prevention, marking a significant milestone in the fight against the disease.

The authority granted approval on November 4, 2025, completing its review in just 12 working days through an innovative regulatory pathway.

ZAMRA used the WHO Listed Authorities (WLA) Collaborative Registration Procedure (CRP) to reach this decision.

This reliance-based approach allows countries to make swift, informed regulatory decisions by building on assessments already conducted by trusted regulatory authorities or the WHO prequalification.

Rather than starting from scratch, regulators can access technical assessment and inspection reports through confidentiality agreements, which eliminates duplicate work and accelerates the approval process while maintaining full national oversight.

Zimbabwe’s Medicines Control Authority (MCAZ) followed closely behind, approving the product after an 18-working-day review.

These back-to-back authorizations demonstrate how regulatory reliance can serve as a powerful tool for bringing innovative health products to market faster.

The timing coincides with World AIDS Day 2025, offering hope for reducing new HIV infections across the African continent.

“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 the WHO Regulation and Prequalification Department.

“It underlines what is possible when regulatory innovation meets urgent public health needs.”

Currently, 69 countries and one Regional Economic Community (CARICOM) participate in the WHO CRP globally.

The procedure enables national regulators to leverage assessments from WHO Prequalification or WHO Listed Authorities, saving valuable time and resources while supporting evidence-based decision-making.

For lenacapavir, the European Medicines Agency (EMA) conducted the initial evaluation through its EU-Medicines for All (EU-M4all) procedure in July 2025.

This assessment combined EMA expertise with input from non-EU regulators and the WHO to evaluate medicines intended for use outside the European Union.

Experts from WHO and regulatory authorities in Kenya, Nigeria, South Africa, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe contributed to the collaborative review, ensuring thorough evaluation from multiple perspectives.

WHO prequalified lenacapavir on October 6, 2025, using a new abridged prequalification pathway based on reliance under the EU-M4all evaluation.

This prequalification makes the drug eligible for procurement by United Nations agencies, global health partners, and individual countries.

The South African Health Products Regulatory Authority (SAHPRA) became the first African regulatory authority to approve lenacapavir on October 27, 2025, working in parallel with the EU-M4all procedure and collaborating with the EMA.

Additional applications through the WHO-listed authorities CRP remain in progress across other countries.

Lenacapavir represents a breakthrough as the first twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV.

Unlike daily oral pills, this long-acting alternative requires only two doses per year, making it highly effective and practical for people who struggle with daily medication routines, face stigma, or have limited healthcare access.

WHO released guidelines on the use of lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis in July 2025, setting the stage for countries to begin implementation.