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 Newsletter

RPQ Newsletter brings 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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8 January 2025

News release

WHO prequalifies diagnostic test to support safer administration of P. vivax malaria treatments

23 December 2024

Departmental update

WHO calls for transformative action towards a greener future in pharmaceutical manufacturing and distribution

20 December 2024

Departmental update

Egypt’s regulatory system reaches WHO maturity level 3 in medicines regulation.

Events

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2 – 6 December 2024

2024 Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers Ensuring Health Equity: Partnerships For Accessible Quality Products

Publications

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Global surveillance and monitoring system for substandard and falsified medical products: activity report, August 2017-December 2021

Access to safe, effective medical products is paramount for global health. This report describes a critical role of WHO in ensuring the quality and safety...

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Safety monitoring of mpox vaccines using cohort event monitoring: a WHO protocol

On the front page also: Protocol identifying number: ERC.0004184. Use of this protocol: As a master protocol to be approved by WHO Ethical Review Committee...

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The third issue of Volume 38, includesConsultation Document: "Good practices of national regulatory authorities in implementing the collaborative registration...

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The second issue of Volume 38, includesConsultation Document: "Good practices of national regulatory authorities in implementing the collaborative registration...

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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 meeting of
the WHO Global Advisory
Committee on Vaccine
Safety and the WHO
Advisory Committee on
Safety of Medicinal,
13–15 November 2023

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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