Regulatory convergence and harmonization: barriers to effective use and adoption of common standards
ABSTRACT Objective To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Metho...
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ftdoajarticles:oai:doaj.org/article:e0b8540441234350a1641647c2e1de83 2023-05-15T15:08:16+02:00 Regulatory convergence and harmonization: barriers to effective use and adoption of common standards María Luz Pombo Analía Porrás Patricia Claudia Saidon Stephanie M Cascio https://doaj.org/article/e0b8540441234350a1641647c2e1de83 EN ES PT eng spa por Pan American Health Organization http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500217&lng=en&tlng=en https://doaj.org/toc/1680-5348 1680-5348 https://doaj.org/article/e0b8540441234350a1641647c2e1de83 Revista Panamericana de Salud Pública, Vol 39, Iss 5, Pp 217-225 Reglamentos preparaciones farmacéuticas control de medicamentos y narcóticos vacunas Américas Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article ftdoajarticles 2022-12-31T12:01:06Z ABSTRACT Objective To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Methods An in-depth analysis of the incorporation of PANDRH Technical Document No. 1 (“TDNo1”) recommendations in member states’ national requirements was carried out. Results The results illustrate the role of PANDRH in promoting convergence/harmonization among its members. Conclusions The study results show that the rate of use of TDs varied greatly by product/area and country. Timing, TD content, and product/area, and, more importantly, national capacities, are critical determinants of the level of TD guideline adoption. While PANDRH TDs have proven instrumental for the harmonization/convergence of member states’ national requirements, as shown by the level of convergence across a majority of the national requirements issued for vaccine licensing, several countries had yet to incorporate common standards due, in large part, to weak national regulatory capacities. Therefore, harmonization/convergence initiatives should include the strengthening of national regulatory capacities as part of their core strategy, which will, in turn, allow for the incorporation and deployment of common standards in all participating countries. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic |
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Directory of Open Access Journals: DOAJ Articles |
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language |
English Spanish Portuguese |
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Reglamentos preparaciones farmacéuticas control de medicamentos y narcóticos vacunas Américas Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Reglamentos preparaciones farmacéuticas control de medicamentos y narcóticos vacunas Américas Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 María Luz Pombo Analía Porrás Patricia Claudia Saidon Stephanie M Cascio Regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
topic_facet |
Reglamentos preparaciones farmacéuticas control de medicamentos y narcóticos vacunas Américas Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
ABSTRACT Objective To evaluate 1) the level of use and adoption of eight Technical Documents (TDs) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2) identify the hurdles that can prevent countries from successfully adopting a common standard. Methods An in-depth analysis of the incorporation of PANDRH Technical Document No. 1 (“TDNo1”) recommendations in member states’ national requirements was carried out. Results The results illustrate the role of PANDRH in promoting convergence/harmonization among its members. Conclusions The study results show that the rate of use of TDs varied greatly by product/area and country. Timing, TD content, and product/area, and, more importantly, national capacities, are critical determinants of the level of TD guideline adoption. While PANDRH TDs have proven instrumental for the harmonization/convergence of member states’ national requirements, as shown by the level of convergence across a majority of the national requirements issued for vaccine licensing, several countries had yet to incorporate common standards due, in large part, to weak national regulatory capacities. Therefore, harmonization/convergence initiatives should include the strengthening of national regulatory capacities as part of their core strategy, which will, in turn, allow for the incorporation and deployment of common standards in all participating countries. |
format |
Article in Journal/Newspaper |
author |
María Luz Pombo Analía Porrás Patricia Claudia Saidon Stephanie M Cascio |
author_facet |
María Luz Pombo Analía Porrás Patricia Claudia Saidon Stephanie M Cascio |
author_sort |
María Luz Pombo |
title |
Regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
title_short |
Regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
title_full |
Regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
title_fullStr |
Regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
title_full_unstemmed |
Regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
title_sort |
regulatory convergence and harmonization: barriers to effective use and adoption of common standards |
publisher |
Pan American Health Organization |
url |
https://doaj.org/article/e0b8540441234350a1641647c2e1de83 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Revista Panamericana de Salud Pública, Vol 39, Iss 5, Pp 217-225 |
op_relation |
http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500217&lng=en&tlng=en https://doaj.org/toc/1680-5348 1680-5348 https://doaj.org/article/e0b8540441234350a1641647c2e1de83 |
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1766339660087296000 |