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.

About us

Highlight

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

All →

7 August 2025

News release

WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical products

24 July 2025

Departmental update

WHO and UNODC release landmark report on contaminated medicines, urging action to protect patients from preventable harm

15 July 2025

Departmental update

WHO prequalifies the first triple diagnostic test for HIV, hepatitis B and syphilis, a milestone toward global disease elimination goals

Events

All →

29 – 30 April 2025

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

Publications

All →

Assessment of shelf life and storage conditions of registered oxytocin in the Southern African Development Community

The value of oxytocin for various indications, including the prevention and treatment of postpartum haemorrhage (PPH) in obstetric practice, is well...

Download

Report of the sixth general meeting of the WHO national control laboratory network for biologicals, Cairo, Egypt, 26-28 November 2024

The sixth general meeting of the World Health Organization – National Control Laboratory Network for Biologicals (WHO-NNB) was held in Cairo, Egypt,...

Download

The Second issue of volume 39 for 2025 includes:Consultation Documents: International Atomic Energy Agency (IAEA)/WHO Guidelines on Good Practices for...

Download

WHO certification scheme on the quality of pharmaceutical products

The World Health Organization (WHO) established the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in...

Download

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

Download

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

Download

Newsletters

All →

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

Download

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)...

Download