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Regulatory reliance principles: concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018)

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English; 16 pages (299.2Kb)
Date
2019-09-16
Document Number
PAHO/HSS/19-003
Author
Pan American Health Organization
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Abstract
The aim of this document is to outline key examples and principles for the practice of regulatory reliance. Its rationale is multifold: (a) it follows on previous discussions at the 2016 Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH), and (b) it fulfills a recommendation by the Conference that requested PAHO to develop a concept paper on reliance for PANDRH stakeholders to consider for endorsement. This concept paper builds on a presentation that was made at the 2016 Conference and integrates global thinking on the subject, including a recent document by the World Health Organization (WHO). The overarching goal is to ensure that PANDRH stakeholders continue to build understanding around reliance in ways that can better inform scenarios for its use.
Subject
Drug and Narcotic Control; Access to Essential Medicines and Health Technologies; Americas; Health Care Coordination and Monitoring; Barriers to Access of Health Services; Health Services Accessibility; Science and Technology Legislation; Health Authorities; Intersectoral Collaboration
Category of PAHO Strategic Plan 2014-2019
Cat 4. Health Systems
URI
https://iris.paho.org/handle/10665.2/51549
Citation
Pan American Health Organization. Regulatory Reliance Principles: Concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, 24 to 26 October, 2018). Washington, D.C.: PAHO; 2019.
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  • General Publications / Publicaciones Generales

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