Ensuring equitable access to safe, effective and quality‑assured health products is fundamental to achieving the highest attainable standard of health for all people. Medicines, vaccines, diagnostics and other health products and technologies play a central role in preventing, diagnosing and treating diseases, and are essential to the goals of universal health coverage, resilient health systems and effective emergency preparedness and response. Reliable access to these products is particularly vital in fragile, conflict‑affected and vulnerable settings.

Robust regulatory systems are critical to safeguarding the quality, safety and performance of health products throughout their entire lifecycle from development and assessment to post‑market surveillance. Where such systems are not yet fully established, WHO plays a unique and indispensable role.

Strategic Framework

RPQ’s mandate is aligned with WHO’s 14th General Programme of Work (2025–2028), the Triple Billion Targets, the global health emergency preparedness and response architecture, the Pandemic Agreement, relevant World Health Assembly resolutions, and the WHO Roadmap for Access 2025–2030. Together, these frameworks guide WHO’s work across five interconnected areas: research and development and production; safety, efficacy and quality assurance; policy and prioritization; procurement and supply chains; and the provision and appropriate use of health products.

Within this broader agenda, the RPQ Strategic Action Plan 2025–2028 sets out five priorities that strengthen global regulatory capacity and ensure the availability of quality‑assured health products:

1. Strengthen country and regional regulatory systems in support of universal health coverage.
2. Increase regulatory preparedness for public health emergencies.
3. Expand and reinforce WHO prequalification and product risk‑assessment processes.
4. Enhance the scope and impact of WHO regulatory support activities.
5. Optimize operational systems and accountability for greater country‑level impact.
   

Enhancing Efficiency and Collaboration

To deliver on its mandate, the RPQ Department draws on extensive global expertise through advisory groups, technical networks, the WHO Coalition of Interested Parties, WHO Collaborating Centres and a wide range of partners. Strong collaboration between headquarters and regional offices ensures that WHO support remains coherent, coordinated and responsive to country priorities. RPQ also drives continuous performance improvement by streamlining procedures, strengthening its Quality Management System and advancing digitalization across its operations. The department also provides a wide range of learning opportunities to support the capacity building of regulators in priority Member States.