The Zambia Medicines Regulatory Authority (ZAMRA) approved lenacapavir tablets and injectable formulations for HIV prevention on 4 November 2025, completing its review in just 12 working days. Zimbabwe’s Medicines Control Authority (MCAZ) followed soon after, finalizing its review in 18 working days. Both approvals were granted through the WHO Listed Authorities (WLA) Collaborative Registration Procedure (CRP), a reliance-based mechanism that allows countries to make rapid, informed regulatory decisions by leveraging assessments from trusted authorities or WHO prequalification. These swift authorizations highlight the potential of regulatory reliance to accelerate access to innovative health products, particularly in urgent public health contexts like HIV prevention.
The approvals coincided with World AIDS Day 2025, signaling a major step toward expanding next-generation HIV prevention across Africa. WHO emphasized that the Collaborative Registration Procedure enables rapid access to lifesaving medicines while allowing national authorities to maintain full oversight and sovereignty over their regulatory decisions. The initiative demonstrates the effectiveness of combining regulatory innovation with urgent public health needs.
WHO CRP works by allowing national regulators to use existing technical assessment and inspection reports from WHO Prequalification or WHO Listed Authorities. This approach avoids duplicative work, saves time and resources, and ensures timely access to quality-assured medicines and vaccines. Currently, 69 countries and one regional economic community participate in the CRP globally. Lenacapavir’s evaluation under the European Medicines Agency (EMA)’s EU-Medicines for All (EU-M4all) procedure in July 2025 served as the reference for the CRP, with contributions from experts across multiple African and non-African regulatory authorities.
Lenacapavir was prequalified by WHO on 6 October 2025 through an abridged reliance-based pathway, making it eligible for procurement by UN agencies, global health partners, and national programs. Prior to the Zambia and Zimbabwe approvals, South Africa’s Health Products Regulatory Authority (SAHPRA) became the first African regulator to approve lenacapavir in October 2025, working alongside EMA under the EU-M4all procedure. Applications in additional countries through WHO CRP are ongoing to expand access further.
Lenacapavir is the first twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV, offering a long-acting alternative to daily oral pills. With only two doses per year, it provides a practical solution for individuals facing adherence challenges, stigma, or limited healthcare access. In July 2025, WHO released guidelines for lenacapavir use and HIV testing strategies for long-acting injectable PrEP, laying the foundation for national implementation across participating countries.
