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:

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"