Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
ABSTRACT Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and econo...
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Format: | Article |
Language: | English |
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Pan American Health Organization
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Series: | Revista Panamericana de Salud Pública |
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Online Access: | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500262&lng=en&tlng=en |
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author | Charles Preston Harinder S. Chahal Analia Porrás Lucette Cargill Maryam Hinds Babatunde Olowokure Rudolph Cummings James Hospedales |
author_facet | Charles Preston Harinder S. Chahal Analia Porrás Lucette Cargill Maryam Hinds Babatunde Olowokure Rudolph Cummings James Hospedales |
author_sort | Charles Preston |
collection | DOAJ |
description | ABSTRACT Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems—may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative’s concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments. |
first_indexed | 2024-12-12T08:43:43Z |
format | Article |
id | doaj.art-d6b27901d33a4187a0f0683495132686 |
institution | Directory Open Access Journal |
issn | 1680-5348 |
language | English |
last_indexed | 2024-12-12T08:43:43Z |
publisher | Pan American Health Organization |
record_format | Article |
series | Revista Panamericana de Salud Pública |
spelling | doaj.art-d6b27901d33a4187a0f06834951326862022-12-22T00:30:40ZengPan American Health OrganizationRevista Panamericana de Salud Pública1680-5348395262268S1020-49892016000500262Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member statesCharles PrestonHarinder S. ChahalAnalia PorrásLucette CargillMaryam HindsBabatunde OlowokureRudolph CummingsJames HospedalesABSTRACT Improving basic capacities for regulation of medicines and health technologies through regulatory systems strengthening is particularly challenging in resource-constrained settings. “Regionalization”—an approach in which countries with common histories, cultural values, languages, and economic conditions work together to establish more efficient systems—may be one answer. This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. The initiative’s concept and design includes a number of features and steps intended to enhance sustainability in resource-constrained contexts. The latter include 1) leveraging existing platforms for centralized cooperation, governance, and infrastructure; 2) strengthening regulatory capacities with the largest potential public health impact; 3) incorporating policies that promote reliance on reference authorities; 4) changing the system to encourage industry to market their products in CARICOM (e.g., using a centralized portal of entry to reduce regulatory burdens); and 5) building human resource capacity. If implemented properly, the CRS will be self-sustaining through user fees. The experience and lessons learned thus far in implementing this initiative, described in this report, can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500262&lng=en&tlng=enCooperación internacionallegislación farmacéuticaBarbadosGuyanaJamaicaTrinidad y TobagoIndias Occidentales |
spellingShingle | Charles Preston Harinder S. Chahal Analia Porrás Lucette Cargill Maryam Hinds Babatunde Olowokure Rudolph Cummings James Hospedales Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states Revista Panamericana de Salud Pública Cooperación internacional legislación farmacéutica Barbados Guyana Jamaica Trinidad y Tobago Indias Occidentales |
title | Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states |
title_full | Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states |
title_fullStr | Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states |
title_full_unstemmed | Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states |
title_short | Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states |
title_sort | regionalization as an approach to regulatory systems strengthening a case study in caricom member states |
topic | Cooperación internacional legislación farmacéutica Barbados Guyana Jamaica Trinidad y Tobago Indias Occidentales |
url | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000500262&lng=en&tlng=en |
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