Daijiworld Media Network – Geneva
Geneva, Dec 2: In a major boost to Africa’s HIV prevention efforts, the Zambia Medicines Regulatory Authority (ZAMRA) has granted rapid approval to lenacapavir tablets and injectable formulations, clearing them on November 4, 2025, after just 12 working days of review. Zimbabwe’s Medicines Control Authority (MCAZ) followed soon after, authorising the product in only 18 working days.
The swift decisions were made using the WHO Listed Authorities (WLA) Collaborative Registration Procedure (CRP), a regulatory reliance pathway that enables countries to fast-track approvals by leveraging assessments from trusted global regulators or WHO prequalification. The milestone comes as the world marks World AIDS Day 2025, signalling accelerating access to next-generation HIV prevention tools across the continent.
“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, WHO Regulation and Prequalification Department. “It underlines what is possible when regulatory innovation meets urgent public health needs.”
Reliance speeds up access
The CRP mechanism allows national regulators to obtain technical assessment and inspection reports from WHO Prequalification or trusted regulatory authorities under confidentiality agreements. This avoids duplication, conserves resources, and speeds up decision-making without compromising national regulatory authority.
Sixty-nine countries and the CARICOM Regional Economic Community now participate in the CRP globally.
Lenacapavir’s assessment under the European Medicines Agency’s EU-Medicines for All (EU-M4all) procedure—issued in July 2025—served as the primary reference for the CRP. The EU-M4all pathway incorporates input from non-EU regulators and WHO, enabling a robust, globally informed evaluation.
Regulators from Kenya, Nigeria, South Africa, Thailand, Uganda, Vietnam, Zambia and Zimbabwe contributed to the assessment, ensuring a thorough, collaborative review that supported the rapid national approvals. WHO prequalified lenacapavir on October 6, 2025, via an abridged reliance-based pathway under EU-M4all, making it eligible for procurement by UN agencies and global health partners.
On October 27, 2025, South Africa’s SAHPRA became the first African regulatory authority to approve lenacapavir, acting in parallel with the EU-M4all assessment and in collaboration with EMA.
A breakthrough in HIV prevention
Lenacapavir is the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV, offering a long-acting, highly effective alternative to daily oral pills. With only two doses required per year, it is expected to be transformative for people facing challenges with adherence, stigma, or limited access to healthcare facilities.
In July 2025, WHO issued new guidelines on the use of lenacapavir for HIV prevention and testing strategies for long-acting injectable PrEP, paving the way for national rollouts.
Applications for lenacapavir under the WLA-CRP continue in several other countries, with global health agencies projecting that these fast-tracked approvals will significantly accelerate the continent’s progress toward ending new HIV infections.