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欧洲法规中的草药

Herbal medicines in European regulation.

作者信息

Benzi G, Ceci A

机构信息

European Agency for the Evaluation of Medicinal Products (EMEA), London, UK.

出版信息

Pharmacol Res. 1997 May;35(5):355-62. doi: 10.1006/phrs.1997.0132.

DOI:10.1006/phrs.1997.0132
PMID:9299199
Abstract

Herbal medicines are assuming large use in the primary healthcare of individuals and communities consistently with the growing interest in traditional and alternative systems of medicine in many developed countries. Consumer surveys show a positive public attitude to complementary medicine. The regulation of herbal medicines is characterized by large differences depending on the ethnological, medical, and historical background of each country. The WHO Guidelines for the Assessment of Herbal Remedies, adopted by the International Conference of Drug Regulatory Authorities (Ottawa, October 1991), contain the basic elements of legislation designed to assist those countries wishing to develop an appropriate legislation and registration procedure for herbal medicines used. The WHO suggested that the different States should be urged: to give correct importance concerning the utilization of their traditional systems of medicine; to make a systematic inventory and assessment of the medical plants used by traditional practitioners and by the population; to intensify activities leading to cooperation between those providing traditional medicine and modern healthcare, respectively, especially as regards the use of scientifically proven, safe and effective traditional remedies. The goals of these suggestions are to facilitate the scientific evaluation and the eventual integration of traditional medicine into the national healthcare system, critically assisting an eventual rational use of traditional medicine through development of technical guidelines and international standards.

摘要

随着许多发达国家对传统医学和替代医学系统的兴趣日益浓厚,草药在个人和社区的初级医疗保健中得到了广泛应用。消费者调查显示公众对补充医学持积极态度。草药的监管因各国的民族学、医学和历史背景存在很大差异。1991年10月在渥太华召开的药品监管当局国际会议通过的《世界卫生组织草药评估指南》包含了旨在协助那些希望为所用草药制定适当立法和注册程序的国家的立法基本要素。世界卫生组织建议敦促不同国家:正确重视本国传统医学系统的利用;对传统从业者和民众使用的药用植物进行系统清查和评估;加强分别提供传统医学和现代医疗保健的各方之间的合作活动,特别是在使用经科学验证、安全有效的传统药物方面。这些建议的目标是促进对传统医学的科学评估,并最终将其纳入国家医疗保健系统,通过制定技术指南和国际标准,批判性地协助最终合理使用传统医学。

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