The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage
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. Howev...
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doaj-7110f7cf455c49de894014b902f01ab42020-11-25T03:46:29ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2020-08-01710.3389/fmed.2020.00457553484The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health CoverageAlireza Khadem Broojerdi0Hiiti Baran Sillo1Razieh Ostad Ali Dehaghi2Mike Ward3Mohamed Refaat4Jane Parry5Regulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, SwitzerlandRegulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, SwitzerlandRegulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, SwitzerlandRegulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, SwitzerlandRegulatory Systems Strengthening Team, Regulation and Safety Unit, World Health Organization, Geneva, SwitzerlandSpecialist Public Health Writer, Hamilton, ON, CanadaNational 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.https://www.frontiersin.org/article/10.3389/fmed.2020.00457/fullglobal benchmarking toolGBTregulatory systems strengtheningregulationregulation of medical productsnational regulatory authority |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Alireza Khadem Broojerdi Hiiti Baran Sillo Razieh Ostad Ali Dehaghi Mike Ward Mohamed Refaat Jane Parry |
spellingShingle |
Alireza Khadem Broojerdi Hiiti Baran Sillo Razieh Ostad Ali Dehaghi Mike Ward Mohamed Refaat Jane Parry The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage Frontiers in Medicine global benchmarking tool GBT regulatory systems strengthening regulation regulation of medical products national regulatory authority |
author_facet |
Alireza Khadem Broojerdi Hiiti Baran Sillo Razieh Ostad Ali Dehaghi Mike Ward Mohamed Refaat Jane Parry |
author_sort |
Alireza Khadem Broojerdi |
title |
The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage |
title_short |
The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage |
title_full |
The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage |
title_fullStr |
The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage |
title_full_unstemmed |
The World Health Organization Global Benchmarking Tool an Instrument to Strengthen Medical Products Regulation and Promote Universal Health Coverage |
title_sort |
world health organization global benchmarking tool an instrument to strengthen medical products regulation and promote universal health coverage |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Medicine |
issn |
2296-858X |
publishDate |
2020-08-01 |
description |
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. |
topic |
global benchmarking tool GBT regulatory systems strengthening regulation regulation of medical products national regulatory authority |
url |
https://www.frontiersin.org/article/10.3389/fmed.2020.00457/full |
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