国外上市药品撤市的经验及对我国上市中药淘汰的启示  

Experience of Withdrawal of Drugs Abroad and Directions for the Withdrawal of Products of Traditional Chinese Medicine from Market

作　　者：杨晓燕[1] 柳强妮[1] 吴健鸿[1] 曾繁典[1] 刘佳[2] 张承绪[2] 

机构地区：[1]华中科技大学同济医学院临床药理研究所,武汉430030 [2]国家食品药品监督管理局药品评价中心

出　　处：《药物流行病学杂志》2009年第6期391-395,共5页Chinese Journal of Pharmacoepidemiology

基　　金：国家食品药品监督管理局药品评价中心国家科技支撑计划课题(2006BAI21B11)

摘　　要：目的:介绍发达国家,特别是美国上市药品撤市状况及技术规程,为我国建立相关制度提供经验。方法:检索文献和国外药品管理部门网站(FDA网站,WHO网站等),从中获取信息,归纳药品撤市的原因、时间及相关程序。结果:以有效性和安全性为基础的效益风险比是决定药品撤市的唯一标准。诸多复杂的因素会影响药物效益-风险的评估,也会影响最终是否作出将药品撤出市场的决定。这些因素包括①出现罕见、不可预测的不良反应;②药品出现比预期更严重的不良反应;③临床用药有更安全的选择;④联合用药导致严重不良反应;⑤容易被误用;⑥其他可选的风险管理方案失败;⑦药品有效性缺失。结论:美国等发达国家实施药品撤市管理工作较早,其制度以及工作程序值得借鉴。Objective：To review the status and procedures to withdraw drugs from the market in developed countries, especially in USA.Method：Papers and webs of drug administrations abroad were searched（such as FDA,WHO）, in order to get messages and reports about timeline,reasons and programs of drug withdrawal from the market.Result：The risk-to-benefit ratio was based on drug efficiency and safety.The balance of the ratio greatly contributed to the decision to withdraw a drug from the market.Many complex factors went into making judgments about benefits and risks of drugs and into ultimately deciding whether a drug should be taken off the market, such as rare and unpredictable adverse drug reaction; more serious adverse drug reactions than predicated, available safer options, dangerous combinations, improper use, the failure of other risk management options and the limit of drug efficiency. Conclusion： The procedure of the drug with- drawal from the market was conducted in developed countries, such as USA, for many years, whose experiences are worth studying.

关 键 词：上市中药 撤市 效益-风险比 

分 类 号：R951[医药卫生—药学]