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Cooperation Agreements, Memorandums of Understanding, and Letters of Intent as Instruments to Facilitate the Implementation of Reliance in Latin America

Rodríguez, Heraclio
; 
De Lucia, María Lucia
; 
Liberti, Lawrence
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Journal article
Date
2022-09-26
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Department
Subject
Agreement
 Cooperation
 Exchange
 Recognition
 Reliance
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http://hdl.handle.net/20.500.12613/10456
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LibertiEtAl-JournalArticle-2022-09.pdf
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http://dx.doi.org/10.1016/j.clinthera.2022.06.005
Abstract
For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International Conference of Drug Regulatory Authorities, have encouraged regulators to adopt reliance and recognition pathways to reduce duplication, improve efficiency and efficacy, and strengthen regulatory capabilities, in order to facilitate marketing authorization approval, thereby maintaining supply chain integrity. Several factors have limited the more widespread implementation of reliance pathways in Latin America, among which is having the appropriate legal tools in place between and among agencies. Key among these tools are the Memorandum of Understanding (MOU) and cooperation agreements. Herein we have reviewed the content and the characteristics of MOUs and cooperation agreements available on the official websites of the regulatory agencies of the region (we found 11 multilateral MOUs and 8 cooperation agreements published), signed by Latin American agencies and interregional organizations. In this commentary, common characteristics are identified and recommendations for further implementation are made to promote communication, information sharing, and trust, thereby supporting the broader use of reliance pathways in the region.
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Heraclio Rodríguez, María Lucia De Lucia, Lawrence Liberti, Cooperation Agreements, Memorandums of Understanding, and Letters of Intent as Instruments to Facilitate the Implementation of Reliance in Latin America, Clinical Therapeutics, Volume 44, Issue 8, 2022, Pages 1107-1128, ISSN 0149-2918, https://doi.org/10.1016/j.clinthera.2022.06.005.
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Elsevier
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Clinical Therapeutics, Vol. 44, Iss. 8
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