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

[WHO] 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,

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