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 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

All →

20 June 2024

News release

WHO issues warning on falsified medicines used for diabetes treatment and weight loss

19 June 2024

Departmental update

WHO and United States Food and Drug Administration extend the CRP-Lite pilot

14 June 2024

Departmental update

Zimbabwe becomes the sixth country in Africa to reach WHO maturity level 3 in regulation of medicines

12 June 2024

Departmental update

WHO joins partners at ASEAN regional meeting to boost access to quality diagnostic testing

Publications

All →

Establishing quality specifications for medicines, vaccines and in vitro diagnostics: week of quality 2023 training kit

Ensuring quality of the health product ensures its safety and efficacy. Manufacturers in low- and middle-income countries (LMICs) face challenges to achieve...

Download

The first issue of Volume 38, includesConsultation Documents:fluodeoxyglucose (18F) injection (fluodeoxyglucosi (18F) solution injectabilis)ATC/DDD ClassificationATC/DDD...

Download

Enhancing compliance to good manufacturing practices and pharmaceutical quality system requirements in vaccine production: Virtual training marathon kit 2023

The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers...

Download

Report of the fifth general meeting of the WHO national control laboratory network for biologicals, Bangkok Sukhumvit, Thailand, 13-15 December 2023

This is the meeting report of the fifth general meeting of the World Health Organization – National Control Laboratory Network for Biologicals (WHO-NNB),...

Download

External assessment report on programmes in the Department of Regulation and Prequalification

Download

External Assessment Report on programmes in the Department of Regulation of Medicines and other Health Technologies

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

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

Download