Department of Regulation and Prequalification 2023 annual report

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.

Our numerous achievements include the designation of national regulatory authorities from the Republic of Korea, Singapore, and Switzerland as the first WHO-Listed Authorities. The National Regulatory Authority of Saudi Arabia has reached maturity level 4, and Türkiye has achieved maturity level 3. These milestones illustrate the RPQ’s coordinated eff orts in strengthening regulatory systems. This initiative will be further expanded in 2024 and 2025, alongside advocating for the implementation of reliance mechanisms and changes in procurement practices.