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 →

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)

24 December 2025

Departmental update

WHO prequalifies the first two rapid antigen detection tests for COVID-19

Events

All →

29 – 30 April 2025

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

Publications

All →

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

Download

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...

Download

Driving quality across the product lifecycle for medicines, vaccines, biotherapeutic products, and in vitro diagnostics: Week of Quality 2024 training kit

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

Download

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...

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

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

Download