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 →This policy on the evaluation and designation of regulatory authorities as WHO listed authorities was developed following broad public consultation and...
WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products -...
The World Health Organization (WHO) considers medical products and other health technologies one of the six building blocks of health systems. Unlike...
Global vaccine safety blueprint - landscape analysis
Very few public-health interventions have been as successful as immunizations in preventing untimely deaths. Over the past thirty-five years, vaccines...
Events
Documents
All →Supplement to mpox protocol section 3.7: Study flow: data sources and data collection
Value of social media and other online listening posts in Pharmacovigilance - Questions
Value of social media and other online listening posts in Pharmacovigilance
Results of Literature Review and Survey of COVID-19 Vaccine Safety Assessment Activities
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"