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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16 November 2025

Departmental update

A flagship program: Virtual cGMP Training Marathon to build manufacturing workforce skills across all WHO regions

26 October 2025

Departmental update

South Africa launches National Action Plan to protect millions from substandard and falsified medical products

30 September 2025

Departmental update

Ethiopia achieves major milestone in medicines regulation reaching WHO Maturity Level 3

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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Estimation of background rates of adverse events of special interest in neonatal outcomes: preterm births, stillbirths, neonatal deaths and low birthweight

During pregnancy, women and infants are predisposed to specific infections due to various immunological and physiological changes. These infections can...

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The global smart
pharmacovigilance strategy

Trust in regulated medical products (medicines, vaccines and other health products) to protect health, is mostly based on a number of principles: the...

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World Local Production Forum on enhancing access to medicines and other health technologies: report of the third meeting, Abu Dhabi, United Arab Emirates, 7–9 April 2025

This report provides an overview of the third WLPF, held from April 7 to 9, 2024, in Abu Dhabi, United Arab Emirates. Organized by the WHO Local Production...

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The Third issue of volume 39 for 2025 includes:Consultation Documents: Cefiderocol sulfate tosilate (cefiderocoli sulfas tosilatum) Cefiderocol powder...

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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 48th meeting
of the WHO Global Advisory
Committee on Vaccine Safety,
15–16 May 2025

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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