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

Regulatory Systems Strengthening (RSS)

Quality-assured, safe and effective medicines, vaccines and medical devices are fundamental to a functioning health system. Unlike many other commodities, though, patients, consumers and health professionals are not in a position to judge their quality, safety and appropriate use. Regulatory authorities responsible for the oversight of medical products are entrusted by governments to ensure that products on the market are legally authorized, safe and perform as claimed when used according to directions.

Publications

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

Delivering Quality-Assured medical products for all - 2019–2023
WHO’s five-year plan to help build effective and efficient regulatory systems
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Roadmap for access to medicines, vaccines and health product 2019-2023: comprehensive support for access to medicines, vaccines and other health products
16 April 2019

Roadmap for access to medicines, vaccines and health product 2019-2023: comprehensive support for access...

Equitable access to health products is a global priority, and the availability, accessibility, acceptability, and affordability of health products of...

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Towards Access 2030 - WHO Medicines and Health Products Programme Strategic
9 August 2017

Towards Access 2030 - WHO Medicines and Health Products Programme Strategic

The new 2030 development agenda and increasing globalization of health products development and supply have generated a need—and an opportunity—for...

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WHO Global Benchmarking Tool (‎GBT)‎ for evaluation of national regulatory system of medical products: manual for benchmarking and formulation of institutional development plans
3 March 2024

WHO Global Benchmarking Tool (‎GBT)‎ for evaluation of national regulatory system of medical products:...

This manual is intended to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development...

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Global competency framework for regulators of medicines
15 November 2023

Global competency framework for regulators of medicines

The Global Competency Framework for Regulators of Medicines (GCF) provides a framework for best practices and general considerations aimed at harmonizing...

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Manual for the performance evaluation of regulatory authorities seeking the designation as WHO-listed authorities
14 November 2023

Manual for the performance evaluation of regulatory authorities seeking the designation as WHO-listed...

The Manual for the performance evaluation of regulatory authorities seeking the designation as WHO-listed authorities should be read in conjunction...

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Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities - Thumbnail
14 November 2023

Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed...

The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provides procedural information (processes,...

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Implementing quality management systems in national regulatory authorities: Examples and practices
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...

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Evaluating and publicly designating regulatory authorities as WHO listed authorities
21 June 2021

Evaluating and publicly designating regulatory authorities as WHO listed authorities

This policy on the evaluation and designation of regulatory authorities as WHO listed authorities was developed following broad public consultation and...

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WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products - Revision VI
10 May 2021

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...

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Guidance on developing a national deployment and vaccination plan for COVID-19 vaccines
16 November 2020

Guidance on developing a national deployment and vaccination plan for COVID-19 vaccines

This is an outdated version of this Interim Guidance which has since been updated. The latest version can be found here: https://www.who.int/publications/i/item/WHO-2019-nCoV-Vaccine-deployment-2021.1-eng The Guidance...

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