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. 2020 Aug 19:7:457.
doi: 10.3389/fmed.2020.00457. eCollection 2020.

The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage

Alireza Khadem Broojerdi  1 , Hiiti Baran Sillo  1 , Razieh Ostad Ali Dehaghi  1 , Mike Ward  1 , Mohamed Refaat  1 , Jane Parry  2
Affiliations

The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage

Alireza Khadem Broojerdi et al. Front Med (Lausanne). .

Abstract

National regulatory authorities (NRAs) are the gatekeepers of the supply chain of medical products, and they have a mandate to ensure the quality, safety and efficacy of medicines, vaccines, blood, and blood products, medical devices, including diagnostics and traditional, or herbal medicines. However, the majority of the world's regulators are still struggling to reach a level of maturity, whereby they have a stable, well-functioning and integrated regulatory system. The World Health Organization (WHO) has developed a Global Benchmarking Tool (GBT) as part of its five-step capacity building program to assist NRAs, using the tool, they can benchmark their own strengths and areas of weakness, and then engage in a formal benchmarking process together with WHO and international experts in order to formulate an effective and workable institutional development plan. The GBT is comprehensive across the entire product life cycle and allows benchmarking to be customized to the needs of the NRA. It has evolved from decades of experience using a variety of benchmarking tools, within WHO and other stakeholder organizations. By the end of December 2019, 26 countries had undergone formal benchmarking, and a further 54 countries had used the GBT to conduct self-benchmarking exercises assisted by WHO.

Keywords: GBT; NRA; RSS; global benchmarking tool; national regulatory authority; regulation; regulation of medical products; regulatory systems strengthening.

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Figures

Figure 1
Figure 1
WHO five-step approach to national regulatory agency capacity building.
Figure 2
Figure 2
WHO global benchmarking tool performance maturity levels. Source: World health Organization.
Figure 3
Figure 3
Benchmarking process.
Figure 4
Figure 4
Countries/areas targeted for WHO regulatory system strengthening program and benchmarked against GBT indicators, January 2016- September 2019.
See this image and copyright information in PMC

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