Department of Regulation and Prequalification 2025 annual report

Overview

WHO’s work in the area of access and regulation is guided by the WHO 14th General Programme of Work 2025–2028; the WHO Triple Billion Targets, the Health Emergency Preparedness and Response architecture, the Pandemic Agreement (adopted by WHO Member States in April 2025), relevant resolutions adopted by Member States in the World Health Assembly and by the Roadmap for action 2025 – 2030: Access to safe, effective and quality-assured health products and technologies, which presents WHO’s strategy for  increasing access to safe, effective and quality-assured health products and technologies towards achievement of the Sustainable Development Goals and the principles of Universal Health Coverage.

In this context, the Department of Regulation and Prequalification provides two critical functions: capacity-building to strengthen regulatory systems to ensure the quality and safety of health products throughout the life cycle, and the prequalification of health products needed by countries that have not yet established a robust, resilient and reliable regulatory authority.

The Department of Regulation and Prequalification is now embedded in the larger Health Systems, Data and Access Division and is facing new challenges with concrete solutions, through the introduction of cost efficiency measures, streamlining operational procedures and leveraging the use of external institutional and human resource capacities.

The 2025 annual report of the Department of Regulation and Prequalification presents achievements and challenges encountered in 2025. The current report follows the structure of the previous Strategic Action Plan of the Department of Regulation and Prequalification as the new Strategic Action Plan for the period 2025 – 2028 was launched mid-year, in July 2025.

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