Department of Regulation and Prequalification 2024 annual report

Overview

The World Health Organization (WHO) Department of Regulation and Prequalification plays a unique role in the global health ecosystem through providing guidance, supporting WHO Member States, and facilitating collaboration among stakeholders around the regulation of medical products across their lifecycle.

The Department’s numerous achievements in 2024 include important milestones which show the progress made on our long-term goals. Key accomplishments include the consolidation of the WHO-Listed Authority (WLA) framework now with 36 regulatory agencies/systems, from 34 countries (33 WHO Member States).  This accomplishment, among many more illustrates the RPQ’s coordinated efforts in strengthening regulatory systems. Improvement in performance in a number of prequalification activities, includes enlarging the scope to medical devices, significantly improving timelines in in-vitro diagnostic reviews and recommendations, securing critical approvals in vaccines, expanding medicines prequalification access (including through the Collaboration Registration Procedure), and a turning page in vector control products with major impact in priority areas.

The Department continues to be in the frontline of protection of public health.