Southern Africa: Lenacapavir Approved in Zambia and Zimbabwe in Record Time Through WHO Collaborative Registration Procedure

The Zambia Medicines Regulatory Authority (ZAMRA) has approved lenacapavir tablets and injectable formulations for HIV prevention, granting authorization on 4 November 2025 after just 12 working days of review. The decision was made using the WHO Listed Authorities (WLA) Collaborative Registration Procedure (CRP), a reliance-based pathway that enables countries to make fast, informed decisions by leveraging assessments from trusted regulatory authorities or WHO prequalification. Shortly afterward,…