Effective and efficient regulatory systems: protecting the public and enabling timely access to quality medical products.
Providing guidance and support to WHO Member States and facilitate collaboration among various stakeholders regarding the regulation of medical products across their lifecycle
Regulation and Safety priorities are based on a strategic plan entitled “ Delivering quality-assured medical products for all 2019-2023: WHO's five-year plan to help build effective and efficient regulatory systems”. This plan is designed to assist national regulators to deliver regulation that protects the public while enabling timely access to quality products and encouraging innovation. It is closely aligned with WHO’s 14th General Programme of Work (GPW14), and the Roadmap for Access to Medicines, Vaccines and other Health Products 2019-2023, and prioritizes regulatory initiatives to help our Member States increase access to universal health coverage (UHC), support health emergency responses, and promote healthier populations. The regulatory action plan defines four strategic priorities, two of which direct the work in Regulation and Safety:
- Strengthen country and regional regulatory systems in line with the drive towards UHC
- Increase regulatory preparedness for public health emergencies
- Strengthen and expand WHO prequalification and product risk assessment processes
- Increase the scope and impact of WHO’s regulatory support activities
In addition, Regulation and Safety work is guided by the World Health Assembly Resolutions on:
Pharmacovigilance (WHA 16.36)
Strengthening of Regulatory Systems (WHA 67.20)
Substandard and falsified medical products (WHA 65.19)
Highlight
Medical products” includes medicines, vaccines, medical devices including in vitro diagnostics and vector control products.
News
All →Publications
All →Delivering Quality-Assured medical products for all...
Assessment of shelf life and storage conditions of registered oxytocin in the Southern African Development...
The value of oxytocin for various indications, including the prevention and treatment of postpartum haemorrhage (PPH) in obstetric practice, is well...
WHO Drug Information - Volume 39, No. 2
The Second issue of volume 39 for 2025 includes:Consultation Documents: International Atomic Energy Agency (IAEA)/WHO Guidelines on Good Practices for...
Protocol on estimation of thrombocytopenia background rates in children aged 5 months to <15 years in...
This is a master protocol approved by the WHO Research Ethics Review Committee on 20 May 2025. The protocol will be used by study sites that will submit...
Events
Q&A's
Semaglutide injection products
WHO Listed Authorities
Q&A on Myocarditis and Covid-19 Vaccines
Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products
Substandard and falsified medical products: WHO Activities
Substandard and falsified medical products: Scope, scale and harm
Substandard and falsified medical products: Advice to patients and consumers
Disclaimer
"The World Health Organization (WHO) is not responsible for the accuracy or content of the Good Reliance Practices Repository (GRPR) published by the International Pharmaceutical Regulators Programme (IPRP) on IPRP’s website. The link to GRPR does not imply that the GRPR, or IPRP, is endorsed by WHO. This link is provided for convenience only. The designations used to refer to countries, territories and areas as well as the representation of countries, territories and areas, including the delimitation of frontiers or boundaries, in the GRPR follow the institutional style and practice of IPRP, and may be at variance with those used by WHO. They do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries"