Zambia and Zimbabwe Approve Lenacapavir for HIV Prevention in Record Time Using WHO Reliance Pathway

ZAMRA authorized both tablet and injectable formulations on 4 November 2025, completing its review in just 12 working days, while MCAZ finalized its approval in 18 working days.

 

The Zambia Medicines Regulatory Authority (ZAMRA) and Zimbabwe Medicines Control Authority (MCAZ) have rapidly approved lenacapavir, a next-generation HIV prevention medicine, marking a significant milestone in expanding access to innovative HIV prevention across Africa.

ZAMRA authorized both tablet and injectable formulations on 4 November 2025, completing its review in just 12 working days, while MCAZ finalized its approval in 18 working days. These approvals were facilitated using the WHO Listed Authorities (WLA) Collaborative Registration Procedure (CRP), a reliance-based regulatory pathway that allows countries to leverage assessments from trusted authorities or WHO prequalification to make fast, informed decisions.

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Accelerating Access Through Regulatory Innovation

“As the world marks World AIDS Day 2025, these swift approvals demonstrate how the WHO Collaborative Registration Procedure accelerates access to lifesaving medical products while allowing national authorities to retain full oversight,” said Hiiti Silo, Unit Head of Regulation and Safety at WHO.

The CRP allows national regulators to rely on technical assessments, inspection reports, and prequalification reviews already conducted by trusted agencies, avoiding duplication of work and speeding up patient access to quality-assured medicines. To date, 69 countries and one Regional Economic Community (CARICOM) participate in the WHO CRP globally.

Lenacapavir’s rapid assessment was informed by the European Medicines Agency (EMA) EU-Medicines for All (EU-M4all) procedure, which combines EMA expertise with input from non-EU regulators and WHO. Experts from Kenya, Nigeria, South Africa, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe contributed to the evaluation, providing a comprehensive collaborative review.

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WHO Prequalification and Global Rollout

• WHO prequalified lenacapavir on 6 October 2025, under a new abridged reliance pathway, making it eligible for procurement by UN agencies, global health partners, and countries.

• South Africa became the first African regulatory authority to approve lenacapavir on 27 October 2025, in collaboration with EMA and EU-M4all.

• Applications in other African countries through the WHO CRP are ongoing, aiming to expand access continent-wide.

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Lenacapavir: A Game-Changing HIV Prevention Option

Lenacapavir is the first twice-yearly injectable pre-exposure prophylaxis (PrEP), providing a long-acting alternative to daily oral HIV prevention pills. With only two doses per year, it offers a practical solution for individuals facing challenges with adherence, stigma, or limited healthcare access.

WHO released updated guidelines in July 2025 recommending lenacapavir for HIV prevention and outlining strategies for implementing long-acting injectable PrEP in national programs, supporting countries in scaling up access quickly and safely.

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Significance for Public Health in Africa

These approvals demonstrate the potential of regulatory reliance to accelerate access to essential medicines, helping countries achieve faster prevention of new HIV infections and improve health outcomes. They also highlight the effectiveness of international collaboration in regulatory science, enabling rapid responses to urgent public health needs.

Lenacapavir’s approval represents a transformative step in HIV prevention, offering greater choice, convenience, and protection for populations at risk across Africa.