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

Regulatory updates on COVID-19

Documents posted here were prepared for national regulatory authorities, regional pharmaceutical advisors, regulatory networks and associated stakeholders to provide timely information around development and regulatory approval of COVID-19 related diagnostics, treatments and vaccines.

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 →

30 August 2022

Statement

WHO statement regarding COVID-19 immunization errors in children

15 June 2023

Departmental news

Strengthening Quality Local Production: The First Week of Quality Wraps Up with Resounding Success

11 June 2023

Departmental news

Launching the Inaugural Day of the Week of Quality

15 May 2023

Departmental news

Join the Week of Quality: On the origin of specifications

Events

All →

12 October 2021 13:00 – 15:00 CET

WHO QMS Guidance Launch Webinar

5 – 6 July 2022

Steering Committee meeting of the WHO Member State mechanism on SF Medical Products

19 September 2022

Call for experts

Call for Experts - Technical Advisory Group on WHO Listed Authorities (TAG-WLA)

22 August 2022

Call for experts

Call for experts: Technical Advisory Group on Local Production and Technology Transfer of Health Products

Areas of work

Substandard and falsified medical products

Regulatory systems strengthening

Pharmacovigilance

Supporting regulatory networks

Q&A's

All →

Coronavirus disease (COVID-19): Corticosteroids, including dexamethasone

Contaminated medicines affecting children

Substandard and falsified medical products: Advice to patients and consumers

Q&A on Myocarditis and Covid-19 Vaccines

Groups

WHO Advisory Committee on Safety of Medicinal Products (ACSoMP)

The Global Advisory Committee on Vaccine Safety

Medical product alert

2 May 2023

Medical product alert

Statement on the risks associated with use of valproic acid (sodium valproate) in women and girls of childbearing potential

WHO Drug Information

WHO drug information provides an overview of topics of current relevance relating to drug development and regulation. Latest lists of proposed and recommended International Nonproprietary Names for Pharmaceutical Substances (INN) are also included.

Documents

All →

18 November 2021

The WHO Essential Medicines List Antibiotic Book: improving antibiotic AWaReness

18 November 2021

The WHO Essential Medicines List Antibiotic Book: infographics

12 September 2021

38th WHO Regulatory Update on COVID-19

9 August 2021

37th WHO Regulatory Update on COVID-19

Publications

All →

Delivering Quality-Assured medical products for all - 2019–2023

WHO’s five-year plan to help build effective and efficient regulatory systems

Download

Guidance for clinical case management of
thrombosis with thrombocytopenia syndrome
(TTS) following vaccination to prevent
coronavirus disease (COVID-19)

Thrombotic Thrombocytopenia Syndrome (TTS) has emerged as a new adverse event following immunization in individuals vaccinated with COVID-19 non-replicant...

Download

Report of the second joint meeting (hybrid) of the WHO Global Advisory Committee on Vaccine Safety and the WHO Advisory Committee on Safety of Medicinal Products, 14–16 December 2022

The Global Advisory Committee on Vaccine Safety (GACVS) was established in 1999 to provide independent, authoritative scientific advice to WHO on vaccine...

Download

The first issue of Volume 37, includesConsultation DocumentsMiltefosine capsules (miltefosini capsules)Miltefosine (miltefosinum)Zidovudine (zidovudinum)International...

Download

Virtual cGMP Training Marathon for Vaccine Manufacturing: Questions & Answers

The 3 rd Virtual cGMP Training Marathon for Vaccine Manufacturing was delivered virtually by the LPA Unit in a newly designed format from 8 November to...

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

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

Download

Health topics

Physical environment

Antimicrobial resistance

Substances

Biologicals

Physiological interventions

Blood products

Health interventions

In vitro diagnostics

Health interventions

Medicines

Communicable diseases

Ebola virus disease

Health systems

Palliative care

Health systems

Substandard and falsified medical products

Other

Universal health coverage

Health interventions

Vaccines and immunization

Related teams

Health products policy and standards

Immunization, Vaccines and Biologicals

R&D Blueprint

Highlight

Prequalification

News

Events

Areas of work