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The Regulation and Prequalification Department (RPQ) works in accordance with a Quality Management System (QMS) to ensure the quality of its processes and process outcomes. The structure of the QMS aligns with that recommended in ISO9001:2015. At the top of the QMS’s pyramid of documents sits the Quality Policy that identifies the quality objectives. The Quality Manual comes underneath the Policy and provides guidance on how processes are conducted to ensure quality process outcomes are achieved.
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WHO’s work in the area of access and regulation is guided by the WHO 14th General Programme of Work...
The World Health Organization (WHO) Department of Regulation and Prequalification plays a unique role in the global health ecosystem through providing...
The World Health Organization (WHO) Department of Regulation and Prequalification plays a unique role in the global health ecosystem through providing...
The World Health Organization (WHO) Department of Regulation and Prequalification holds a unique role in the global health ecosystem. RPQ provides essential...
An effective regulatory system plays a critical role in ensuring the quality of health products, spanning from their development in the laboratory to their...
WHO’s Department of Regulation and Prequalification strategic action plan (2025–2028) sets out the five strategic priorities that will enable...
WHO’s 2019–2023 Plan to help build effective and efficient regulatory systems is designed to assist national regulators to deliver regulation that...
Roadmap for access to medicines, vaccines and health product 2019-2023: comprehensive support for access...
Equitable access to health products is a global priority, and the availability, accessibility, acceptability, and affordability of health products of...
Regulation and Prequalification update
The Regulation and Prequalification update in Arabic, Chinese, French, Spanish and Russian are also available from the links below.
Our Director
Director
Professor Rogério Gaspar - Director of Regulation and Prequalification Department at World Health Organization.
Learn moreOur work
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All →Our Team
Mrs. Irena Prat
Team lead - In Vitro Diagnostics Assessment
Telephone: +41 22 791 3927
Email: prati@who.int
Dr Samvel Azatyan
Team lead - Regulatory Convergence and Networks
Telephone: +41 22 791 1506
Email: azatyans@who.int
Miss Carmen A. Rodriguez Hernandez
Team lead - Vaccines & Immunization Devices Assessment
Telephone: +41 22 791 4362
Email: rodriguezhernandezc@who.int
Mr Hiiti Baran Sillo
Unit Head - Regulation and Safety
Telephone: +41 22 791 2486
Email: silloh@who.int
Dr Matthias Mario Stahl
Team lead - Medicines Assessment
Telephone: +41 22 791 3717
Email: stahlm@who.int
Dr Jicui Dong
Unit Head - Product Policies, Access and Manufacturing support
Unit Head - Prequalification
Telephone: +41 22 791 4637
Email: khadembroojerdia@who.int
Publications
All →Delivering Quality-Assured medical products for all...
WHO Drug Information - Volume 40, No. 1
The First issue of volume 40 for 2026 includes:Consultation Documents: - Dapsone (dapsonum)- Dapsone Tablets (dapsoni compressi)International Nonproprietary...
WHO Drug Information - Volume 39, No. 4
The Fourth issue of volume 39 for 2025 includes:Pharmaceutical News- Thin-Layer Chromatography: A Valuable Tool in the Fight Against Substandard/Falsified...
Advancing institutional compliance and continuous improvement in vaccine manufacturing: Virtual training...
The 2024 Virtual cGMP Training Marathon represented a crucial step towards strengthening local vaccine manufacturing capabilities in LMICs. This annual...
Driving quality across the product lifecycle for medicines, vaccines, biotherapeutic products, and in...
Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in low- and middle-income countries (LMICs) face challenges to...