This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and technique...This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.展开更多
药品风险管理贯穿于药品整个生命周期,药品风险效益评估是药品上市前审评与上市后评价的核心内容,积极深入地开展药物警戒活动是提高药品监管水平保障公众用药安全有效的重要环节。国际药物警戒学会(International Society of Pharmacov...药品风险管理贯穿于药品整个生命周期,药品风险效益评估是药品上市前审评与上市后评价的核心内容,积极深入地开展药物警戒活动是提高药品监管水平保障公众用药安全有效的重要环节。国际药物警戒学会(International Society of Pharmacovigilance,ISoP)是权威、独立、非营利性的国际性学术组织,是国际范围内公开、中立分享经验和知识的专业学术平台,旨在提升全球药物警戒的科学性,促进药物警戒和风险管理技术的发展。本文介绍了其组建发展、任务和学术交流方式等内容,提出ISoP为中国药品评价及药物警戒专业人员开启了一扇了解国际药物警戒技术和风险管理策略发展前沿的窗口,值得中国药品评价、药物警戒和药品安全领域科研、学术及医疗机构、药品生产经营企业及政府监管人员的充分关注与积极参与。展开更多
基金Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicines,the Ministry of Science and Technology(No.2009ZX09502-030)the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No. Z0215)
文摘This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.
文摘药品风险管理贯穿于药品整个生命周期,药品风险效益评估是药品上市前审评与上市后评价的核心内容,积极深入地开展药物警戒活动是提高药品监管水平保障公众用药安全有效的重要环节。国际药物警戒学会(International Society of Pharmacovigilance,ISoP)是权威、独立、非营利性的国际性学术组织,是国际范围内公开、中立分享经验和知识的专业学术平台,旨在提升全球药物警戒的科学性,促进药物警戒和风险管理技术的发展。本文介绍了其组建发展、任务和学术交流方式等内容,提出ISoP为中国药品评价及药物警戒专业人员开启了一扇了解国际药物警戒技术和风险管理策略发展前沿的窗口,值得中国药品评价、药物警戒和药品安全领域科研、学术及医疗机构、药品生产经营企业及政府监管人员的充分关注与积极参与。
