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.
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 13th General Programme of Work (GPW13), and the Roadmap for Access to Medicines, Vaccines and other Health Products 2019-2013, 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
Highlight
Medical products” includes medicines, vaccines, medical devices including in vitro diagnostics and vector control products.
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Featured publication | 30 June 2019
Delivering Quality-Assured medical products for all...
WHO’s five-year plan to help build effective and efficient regulatory systems
30 July 2021
WHO Drug Information - Volume 35, No. 2
The second issue of Volume 35, includesConsultation Documents:Linezolid (linezolidum)Remdesivir (remdesivirum)Remdesivir intravenous infusion (remdesiviri...
28 June 2021
Regulatory guidance for assessment and management of applications for marketing authorization of oxytocin
Studies confirm that there is a high prevalence of substandard oxytocin circulating in many low- and middle-income countries (LMICs). According to...
23 June 2021
Implementing quality management systems in national regulatory authorities: Examples and practices
This document has been developed to assist NRAs with the practical implementation of the WHO guideline within their respective contexts. The document...