Regulation and Prequalification

The Department of Regulation and Prequalification (RPQ), within the WHO Health Systems, Access and Data Division, supports Member States in building robust, resilient and reliable regulatory systems and ensures that quality‑assured medicines, vaccines, diagnostics and other health products are available to populations in need.

RPQ’s work is grounded in two core functions:

• strengthening national and regional regulatory systems and promoting reliance to improve oversight of health products and technologies; and
• prequalifying essential health products for use in countries that have not yet established a robust, resilient and reliable regulatory authority and rely on WHO’s assessments to guide procurement and regulatory decision‑making.

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.

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.