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健康和环境风险决策原则的相关性和可行性。

Relevance and feasibility of principles for health and environmental risk decision-making.

机构信息

Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, ON, Canada.

School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.

出版信息

J Toxicol Environ Health B Crit Rev. 2024 Aug 17;27(5-6):189-211. doi: 10.1080/10937404.2024.2338078. Epub 2024 May 14.

Abstract

Globally, national regulatory authorities are both responsible and accountable for health and environmental decisions related to diverse products and risk decision contexts. These authorities provided regulatory oversight and expedited market authorizations of vaccines and other therapeutic products during the COVID-19 pandemic. Regulatory decisions regarding such products and situations depend upon well-established risk assessment and management steps. The underlying processes supporting such decisions were outlined in frameworks describing the complex interactions between factors including risk assessment and management steps as well as principles which help guide risk decision-making. In 2022, experts in risk science proposed a set of 10 guiding principles, further examining the intersection and utility of these principles using 10 diverse risk contexts, and inviting a broader discourse on the application of these principles in risk decision-making. To add to this information, Canadian regulatory practitioners responsible for evaluating health and environmental risks and establishing policies convened at a Health Canada workshop on . This review reports the results derived from this interactive engagement and provides a first pragmatic analysis of the relevance, importance, and feasibility of such principles for health and environmental risk decision-making within the Canadian regulatory context.

摘要

从全球范围来看,各国监管机构对与各种产品和风险决策环境相关的健康和环境决策负有责任并承担相应责任。在 COVID-19 大流行期间,这些机构对疫苗和其他治疗产品进行了监管监督并加快了市场授权。这些产品和情况的监管决策取决于经过充分验证的风险评估和管理步骤。支持这些决策的基本流程在描述风险评估和管理步骤以及有助于指导风险决策的原则之间复杂相互作用的框架中进行了概述。2022 年,风险科学专家提出了一套 10 项指导原则,进一步使用 10 种不同的风险情况检查了这些原则的交叉点和实用性,并邀请更广泛地讨论在风险决策中应用这些原则的问题。为了增加这些信息,负责评估健康和环境风险并制定政策的加拿大监管从业者在加拿大卫生部的一次关于该主题的研讨会上进行了交流。本报告总结了此次互动交流的结果,并对这些原则在加拿大监管背景下进行健康和环境风险决策的相关性、重要性和可行性进行了首次务实分析。

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