摘要
同情用药是指在特定情况下允许对人体使用可能具有疗效但尚未上市的药品。我国初步建立同情用药制度,但尚未正式发布相关管理办法和实施操作细则,无法保障同情用药制度顺利运行。法国通过临时使用授权制度实现药品的同情使用,在分类管理、申请、审评、供给、费用支付、药物警戒等方面都做了明确规定。本文通过借鉴法国临时使用授权制度,建议我国在《中华人民共和国药品管理法》框架下构建同情使用药品的风险效益评估体系、建立伦理审查特殊机制、搭建信息平台,以及对药费支付进一步探讨以完善我国同情用药制度。
An unmarketed drug that may have therapeutic effects can be used on the human body under certain circumstances by compassionate use system.Our country has initially established compassionate use system,but has not officially released the management measures and implementation rules which cannot guarantee the smooth operation of compassionate use system.France uses drug temporary authorization for use to achieve compassionate use of drug,and has made clear provisions on classification management,application,evaluation,supply,cost payment,and pharmacovigilance.To improve China’s compassionate use system,it is suggested that our country can construct the drug risk and benefit evaluation system under compassionate using,establish a special mechanism of ethical review,build an information platform and further discussion on drug payment under the framework of Pharmaceutical Administration Law of the People’s Republic of China,by reference to France’s drug temporary authorization for use.
作者
任磊
柴逸峰
张黎
郭明明
刘峰群
舒丽芯
REN Lei;CHAI Yi-feng;ZHANG Li;GUO Ming-ming;LIU Feng-qun;SHU Li-xin(Demonstration Center of Military Medical Supply,School of Pharmacy,Naval Medical University,SHANGHAI 200433,China;Department of Pharmaceutical Analysis,School of Pharmacy,Naval Medical University,SHANGHAI 200433,China;Department of Military Medical Supply Administration,School of Pharmacy,Naval Medical University,SHANGHAI 200433,ChinaDepartment of Pharmacy,Changhai Hospital,Navy Medical University,SHANGHAI 200433,Chhia;Department of Pharmacy,Fifth Medical Center of China PLA General Hospital,BEIJING 100039,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2020年第8期463-467,共5页
Chinese Journal of New Drugs and Clinical Remedies
基金
“重大新药创制”国家科技重大专项(2017ZX09304030)
上海申康医院发展中心临床科技创新项目(SHDC12019614)
后勤科研课题(BWS13B099)
后勤科研重点课题(BWS17J020)。
关键词
法国
临时使用授权
体恤使用试验
临床试验
France
temporary authorization for use
compassionate use trials
clinical trial
