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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10 March 2026

Departmental update

Singapore sets global first by reaching WHO’s highest classification for medical device regulation

13 February 2026

Departmental update

WHO prequalifies an additional novel oral polio vaccine, strengthening global outbreak response

5 February 2026

Departmental update

Update on the 20th International Conference of Drug Regulatory Authorities (ICDRA)

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 Model RMP Standard Operating Procedure (SOP)

A model SOP is included to support NRAs in establishing standardized procedures for the assessment of RMPs. The SOP outlines the roles and responsibilities...

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Report of the 49th meeting of the WHO Global Advisory Committee on Vaccine Safety, 27-28 November 2025

The Global Advisory Committee on Vaccine Safety (GACVS) was established in 1999 as an independent expert advisory body to WHO on policies and issues related...

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The Fourth issue of volume 39 for 2025 includes:Pharmaceutical News- Thin-Layer Chromatography: A Valuable Tool in the Fight Against Substandard/Falsified...

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Advancing institutional compliance and continuous improvement in vaccine manufacturing: Virtual training marathon kit 2024

The 2024 Virtual cGMP Training Marathon represented a crucial step towards strengthening local vaccine manufacturing capabilities in LMICs. This annual...

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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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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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