WHO TRS (Technical Report Series) 1025, 2020 Annex 13


WHO TRS (Technical Report Series) 1025, 2020 Annex 13

WHO guideline on the implementation of quality management systems for national regulatory authorities Abbreviations 

1. Background:

Implementation of the Thirteenth World Health Organization (WHO) General Programme of Work (2019–2023) (1), as adopted by the Seventy-first World Health Assembly (2018), and the WHO Leadership priorities (2), has attracted much international public health attention to the theme of universal health coverage and to increased access to safe and effective medical products.

Several World Health Assembly resolutions, including WHA67.20 (2014) (3), mandate WHO to provide support to its Member States in strengthening national regulatory systems for medical products. It recognizes that “effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes, that regulators are an essential part of the health workforce, and that inefficient regulatory systems themselves can be a barrier to access to safe, effective and quality medical products” (3). 

Accordingly, to facilitate access to these products, WHO’s vision is for all Member States to have an effective regulatory system that ensures medical products and other health technologies in the market meet internationally recognized standards of quality, safety and efficacy. 

National regulatory authorities (NRAs) are responsible for ensuring the safety, quality and efficacy of medical products within their respective Member States; demonstrating that the services they provide consistently meet legal and regulatory requirements; delivering effective and efficient services; evaluating performance; and making improvements. An effective quality management system (QMS) can help to ensure that the products or services an NRA provides consistently meet statutory and regulatory standards and meet customers’ expectations. A QMS provides opportunities to enhance customer satisfaction; address context-associated risks and opportunities for continued improvement; demonstrate conformity to specific QMS requirements; and assure the quality, safety and efficacy of medical products.

In 2015, WHO developed and launched the WHO Global Benchmarking Tool (GBT) (4). This tool assists WHO and regulators worldwide in evaluating the maturity and performance of regulatory systems and related functions. The GBT includes one indicator that assesses the NRA’s level of development with respect to a QMS (4). Benchmarking results of low- and middle-income countries indicate that the majority of NRAs need to establish and implement a QMS or, if already established, enhance and maintain the QMS.

QMS implementation is challenging for NRAs, owing to the diversity of NRA legal mandates and organizational structures; the different levels of NRA development; and the number of regulatory functions that need to be implemented. WHO has developed this guideline to respond to requests by Member States for an international guideline on implementation of QMSs by NRAs.

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Table of Contents

1. Background 

2. Objectives 

3. Scope 

4. Glossary 

5. Quality management system requirements for national regulatory authorities 

5.1 Quality management system concepts 

5.2 Quality management system requirements 

6. Quality management system implementation methodology 

6.1 Supporting factors for quality management system implementation 

6.2 Situational analysis of quality management system implementation status in the national regulatory authority 

6.3 Gap analysis for developing a roadmap for quality management system implementation 

6.4 Quality management system development and implementation roadmap 

6.5 Activity plan for quality management system implementation 


Appendix 1: References to the WHO Global Benchmarking Tool, revision VI 

Appendix 2: Activity plan for quality management system implementation

WHO TRS (Technical Report Series) 1025, 2020 Annex 13:

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