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The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity

Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regul...

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Autores principales: Guzman, Javier, O'Connell, Erin, Kikule, Kate, Hafner, Tamara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418656/
https://www.ncbi.nlm.nih.gov/pubmed/32784212
http://dx.doi.org/10.1136/bmjgh-2020-003181
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author Guzman, Javier
O'Connell, Erin
Kikule, Kate
Hafner, Tamara
author_facet Guzman, Javier
O'Connell, Erin
Kikule, Kate
Hafner, Tamara
author_sort Guzman, Javier
collection PubMed
description Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system’s functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the efficacy, safety and quality assurance of medicines and populations’ timely access to these medicines. In outlining the benefits of the GBT, this paper also offers some specific ideas for strengthening the GBT framework and process.
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spelling pubmed-74186562020-08-18 The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity Guzman, Javier O'Connell, Erin Kikule, Kate Hafner, Tamara BMJ Glob Health Practice Many low-income and middle-income countries lack the capacity to effectively and efficiently regulate medical products in their countries. To support countries in strengthening their capacity, WHO has developed the Global Benchmarking Tool (GBT) as the global standard for objectively assessing regulatory capacity for medicines and vaccines. The GBT is a game changer because it is the first globally accepted tool for assessing and strengthening national regulatory authorities. The inclusion of an institutional development plan in the GBT methodology provides context-specific actionable steps countries can take to advance their system’s functionality and maturity. The GBT facilitates coordination and improves the effectiveness of regulatory strengthening efforts. The tool also facilitates regulatory reliance and harmonisation, which helps to improve timely access to quality-assured medicines, and creates incentives for trade, particularly in countries and regions with a strong pharmaceutical manufacturing base. The GBT is a necessary tool for creating strong and effective regulatory systems, which are critical for ensuring the efficacy, safety and quality assurance of medicines and populations’ timely access to these medicines. In outlining the benefits of the GBT, this paper also offers some specific ideas for strengthening the GBT framework and process. BMJ Publishing Group 2020-08-11 /pmc/articles/PMC7418656/ /pubmed/32784212 http://dx.doi.org/10.1136/bmjgh-2020-003181 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Practice
Guzman, Javier
O'Connell, Erin
Kikule, Kate
Hafner, Tamara
The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
title The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
title_full The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
title_fullStr The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
title_full_unstemmed The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
title_short The WHO Global Benchmarking Tool: a game changer for strengthening national regulatory capacity
title_sort who global benchmarking tool: a game changer for strengthening national regulatory capacity
topic Practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418656/
https://www.ncbi.nlm.nih.gov/pubmed/32784212
http://dx.doi.org/10.1136/bmjgh-2020-003181
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