Lenacapavir, a groundbreaking HIV prevention medication, has been swiftly approved in Zambia and Zimbabwe, setting a new record through the WHO's Collaborative Registration Procedure. This innovative approach, which relies on assessments from trusted regulatory authorities, has significantly accelerated the approval process, allowing these African nations to access life-saving treatments in record time. The approval of lenacapavir tablets and injectable formulations by the Zambia Medicines Regulatory Authority (ZAMRA) and Zimbabwe's Medicines Control Authority (MCAZ) within just 12 and 18 working days, respectively, showcases the power of regulatory reliance. This method not only streamlines the approval process but also ensures that decisions are made by national authorities, maintaining oversight and sovereignty. The timing of these approvals, coinciding with World AIDS Day 2025, holds immense promise for halting new HIV infections across Africa, offering a rapid gateway to next-generation prevention options. The WHO's Collaborative Registration Procedure, a regulatory reliance mechanism, enables national regulators to make faster, evidence-based decisions by utilizing assessments from trusted regulatory bodies. This approach, which has gained global participation from 69 countries and one Regional Economic Community (CARICOM), avoids redundant work, saves time and resources, and supports sovereign national decision-making. The evaluation of lenacapavir under the European Medicines Agency's EU-Medicines for All (EU-M4all) procedure, which combines EMA expertise with input from non-EU regulators and WHO, served as a reference for the CRP. This collaborative effort, involving experts from various regulatory authorities, contributed to the rapid approvals. WHO prequalified lenacapavir on October 6, 2025, through a new abridged prequalification pathway, making it eligible for procurement by international organizations and countries. The South African Health Products Regulatory Authority (SAHPRA) became the first African regulatory authority to approve lenacapavir on October 27, 2025, in parallel with the EU-M4all procedure and in collaboration with EMA. Applications for lenacapavir in other countries through the WHO Listed Authorities CRP are ongoing, aiming to expand access to this transformative HIV prevention option. Lenacapavir is a groundbreaking twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV, offering a highly effective, long-acting alternative to daily oral pills. With just two doses per year, it provides a practical solution for individuals facing adherence, stigma, or healthcare access challenges. In July 2025, the 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. These rapid approvals demonstrate the potential of regulatory reliance to accelerate access to innovative health products, especially in the context of urgent public health needs. As the world observes World AIDS Day, this achievement highlights the WHO's Collaborative Registration Procedure's role in expediting access to life-saving medical products while ensuring national authority oversight.
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