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)
Other Language Versions
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
Category of PAHO Strategic Plan 2014-2019
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.
Collections
Related items
Showing items related by title, author, creator and subject.
-
Regulatory System Models for Small States/Markets with Limited Resources. 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, 2020-06-26)[Extract]. Regulatory systems are an essential part of well-functioning health systems and critical to the achievement of universal access to health and universal health coverage. Therefore, there is increasing focus on ... -
VII Pan American Network for Drug Regulatory Harmonization (PANDRH) Conference Report
(Ottawa, PAHO, 2013-09)The VII Conference of the Pan American Network for Drug Regulatory Harmonization (CPANDRH VII) was held in Ottawa, Canada, 5–7 September 2013, on the theme Sixteen Years Promoting Good Regulatory Practices in the Region ... -
Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states
(2016-05)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 ...
