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A Comparative Analysis of Post-market Surveillance for Natural Health Products (NHPs).

机译：天然保健品（NHP）上市后监测的比较分析。

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摘要

Natural health products (NHPs) are attractive due to the public's perception that they are natural and safe but there is wide variety of risks associated with these products. Post-market surveillance is the key to control hazards produced from NHPs. A set of activities are involved in post-market surveillance designed to assure the safety, efficacy and quality of products after being launched into the market. Although postmarket surveillance is an efficient tool to preserve the safety of users from adverse reactions of NHPs but there are various challenges associated with performing post-market surveillance specifically for NHPs. This research project is focused on defining a framework for performing post-market surveillance for NHPs and on identifying best practices in its application. An international comparative analysis was undertaken to formulate best practices by reviewing existing frameworks for post-market surveillance of NHPs in Australia, Germany, New Zealand, United Kingdom and United States. Evidence-based best practices are compared with the Canadian post-market surveillance framework to identify key gaps in the Canadian system. Recommendations are provided for bridging each gap, and making the Canadian NHPs surveillance system, strong according to the international standards of best practices.
机译：天然保健品（NHPs）具有吸引力，因为公众认为它们是天然和安全的，但是与这些产品相关的风险却很多。上市后监督是控制NHP产生的危害的关键。上市后监视涉及一系列活动，旨在确保产品投放市场后的安全性，有效性和质量。尽管上市后监督是一种保护用户安全免受NHP不良反应影响的有效工具，但是，专门针对NHP进行上市后监督仍面临各种挑战。该研究项目的重点是为执行NHP的上市后监督定义框架，并确定其应用中的最佳实践。进行了国际比较分析，以通过审查澳大利亚，德国，新西兰，英国和美国的NHP上市后监督框架来制定最佳实践。将基于证据的最佳做法与加拿大上市后监督框架进行比较，以确定加拿大体系中的主要缺陷。根据国际最佳实践标准，提供了一些建议，以弥合每个差距，并使加拿大的NHP监控系统更强大。

著录项

  • 作者

    Kaur, Suman Deep.;

  • 作者单位

    University of Ottawa (Canada).;

  • 授予单位 University of Ottawa (Canada).;
  • 学科 Health Sciences Public Health.;Economics General.;Health Sciences Nutrition.
  • 学位 M.Sc.
  • 年度 2013
  • 页码 117 p.
  • 总页数 117
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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