Regulation and Prequalification

Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

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RPQ Updates

RPQ Updates bring recent highlights, tools and resources, new initiatives and events of the Department of Regulation and Prequalification (RPQ) as we strive to improve access to safe, effective and quality-assured medicines around the world.

Prequalification

World Health Organization Prequalification

The mission of WHO prequalification is to work in close cooperation with national regulatory agencies and other partner organizations to make quality priority medical products available for those who urgently need them.

News

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23 May 2025

Departmental update

3rd World Local Production Forum ends with strong call for health equity, security, and sustainability

11 May 2025

Departmental update

WHO adds Serbia to its series of country case studies on local production ecosystems for pharmaceuticals, vaccines, and biologicals

5 May 2025

Departmental update

WHO launches new learning catalogue to upskill regulatory workforce

Events

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29 – 30 April 2025

Revisiting the WHO Pharmaceutical Starting Materials Certification Scheme (SMACS) - Consultative workshop

Publications

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WHO’s Department of Regulation and Prequalification strategic action plan (2025–2028) sets out the five strategic priorities that will enable...

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Protocol on estimation of Guillain-Barré syndrome background rates in general population in low- and middle-income countries

Background rates of possible adverse events are crucial to monitoring vaccine safety as they help separate potential safety signals following vaccination...

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WHO Global Network of National Quality Control Laboratories for Pharmaceuticals: first meeting report, Rio de Janeiro, Brazil, 1-3 October 2024

The first annual meeting of the World Health Organization (WHO) Global Network of Quality Control Laboratories for Pharmaceuticals (WHO-GNP) was organized...

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A case study on the ecosystem for local production of pharmaceuticals, vaccines and biologicals - The Serbia context

The Local Production and Assistance (LPA) Unit in the Regulation and Prequalification Department (RPQ), Access to Medicines and Health Products Division...

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Cover image of the Call for action "Greener pharmaceuticals regulatory highway"

Call for action on regulatory support for introduction of more sustainable products and services

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An effective regulatory system plays a critical role in ensuring the quality of health products, spanning from their development in the laboratory to their...

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Newsletters

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The WHO pharmaceuticals newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities...

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Report of the 4th joint
meeting of the WHO Global
Advisory Committee on
Vaccine Safety and the
Advisory Committee on
Safety of Medicinal Products,
12–14 November 2024

The Global Advisory Committee on Vaccine Safety (GACVS) was established in 1999, and the Advisory Committee on Safety of Medicinal Products (ACSoMP)...

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