中成药上市后安全性医院集中监测技术规范
|
摘要
2013年国家食品药品监督管理总局药品安全监管司下发了有关生产企业药品重点监测工作的指南,鼓励企业开展重点监测工作。随后,有关中成药上市后安全性医院集中监测的研究日渐增多,掀起了中成药安全性评价研究的一股热潮。然而,纵观目前该领域现状来看,医院集中监测的开展缺乏规范,如设计不合理、漏报、过程质量控制不严格、不良反应判读不规范等,因此,制定相关技术规范非常必要。该规范参照国际药品上市后安全性监测模式和先进设计理念与方法,并在我国相关法律法规和技术文件指导的框架下,结合中成药自身特点以及我国的实际情况,制定而成。目的在于通过实施这类设计的监测获得中成药不良反应发生率、类型、程度及临床表现,发现新的不良反应风险信号,确定危险因素,为制定风险管控计划提供依据。该技术规范已通过中华中医药学会的审核,并被发布,编号T/CACM011-2016。
In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.
In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.
引文
[1]国家食品药品监督管理局药品安全监管司.国家食品药品监督管理局安监司关于征求《关于推动生产企业开展药品重点监测工作的通知(征求意见稿)》意见的函食药监安函[2013]12号[S]. 2013.
[2] Brian L S,Stephen E K.药物流行病学教程[Z].曾繁典,石侣元,詹思延,译. New York:John Wiley&Sons(Asia)Pte Ltd,2008.
[3]卫生部令第81号.药品不良反应报告和监测管理办法[S].2011.
[4]中国中医科学院中医临床基础医学研究所.中成药上市后安全性医院集中监测技术规范[S].中华中医药学会,2017.
[5] Wu Y T,Makuch R W. Detecting rare adverse events in postmarketing studies:sample size considerations[J]. Drug Inf J,2006(40):87.
[6] Tubert-Bitter P,Begaud B,Moride Y,et al. Sample size calculations for single groups postmarketing cohort studies[J]. J Clin Epidemiol,1994(47):435.
[7]国家食品药品监督管理局药品安全监管司国家药品不良反应监测中心.药品不良反应报告和监测工作手册[S]. 2012.
[8] FDA. What is a serious adverse event?[S]. 2016.
[9]翁维良,易丹辉.中医临床研究质量控制与评估[M].北京:人民卫生出版社,2015.
[10] World Medical Association. World medical association declaration of helsinki:ethical principles for medical research involving human subjects[J]. JAMA,2013,310(20):2191.
[11]国家食品药品监督管理总局办公厅.总局办公厅公开征求《药物临床试验质量管理规范(修订稿)》的意见[S]. 2016.
[12]赵梓邯,张琳,李文斌,等.中药毒性与安全性评价研究进展[J].中国实验方剂学杂志,2018,24(20):208.
[13]曹红波,张俊华,翟静波,等.中药注射剂安全性医院集中监测研究的标准化建设[J].世界科学技术——中医药现代化,2016,18(12):2093.
[14]翟静波,张俊华,阎小妍,等.中药注射剂安全性医院集中监测研究的统计分析相关问题及对策[J].世界科学技术——中医药现代化,2017,19(1):166.
[15]郑文科,张俊华,翟静波,等.中药注射剂上市后安全性集中监测研究医院相关问题的思考[J].世界科学技术——中医药现代化,2016,18(12):2101.
[2] Brian L S,Stephen E K.药物流行病学教程[Z].曾繁典,石侣元,詹思延,译. New York:John Wiley&Sons(Asia)Pte Ltd,2008.
[3]卫生部令第81号.药品不良反应报告和监测管理办法[S].2011.
[4]中国中医科学院中医临床基础医学研究所.中成药上市后安全性医院集中监测技术规范[S].中华中医药学会,2017.
[5] Wu Y T,Makuch R W. Detecting rare adverse events in postmarketing studies:sample size considerations[J]. Drug Inf J,2006(40):87.
[6] Tubert-Bitter P,Begaud B,Moride Y,et al. Sample size calculations for single groups postmarketing cohort studies[J]. J Clin Epidemiol,1994(47):435.
[7]国家食品药品监督管理局药品安全监管司国家药品不良反应监测中心.药品不良反应报告和监测工作手册[S]. 2012.
[8] FDA. What is a serious adverse event?[S]. 2016.
[9]翁维良,易丹辉.中医临床研究质量控制与评估[M].北京:人民卫生出版社,2015.
[10] World Medical Association. World medical association declaration of helsinki:ethical principles for medical research involving human subjects[J]. JAMA,2013,310(20):2191.
[11]国家食品药品监督管理总局办公厅.总局办公厅公开征求《药物临床试验质量管理规范(修订稿)》的意见[S]. 2016.
[12]赵梓邯,张琳,李文斌,等.中药毒性与安全性评价研究进展[J].中国实验方剂学杂志,2018,24(20):208.
[13]曹红波,张俊华,翟静波,等.中药注射剂安全性医院集中监测研究的标准化建设[J].世界科学技术——中医药现代化,2016,18(12):2093.
[14]翟静波,张俊华,阎小妍,等.中药注射剂安全性医院集中监测研究的统计分析相关问题及对策[J].世界科学技术——中医药现代化,2017,19(1):166.
[15]郑文科,张俊华,翟静波,等.中药注射剂上市后安全性集中监测研究医院相关问题的思考[J].世界科学技术——中医药现代化,2016,18(12):2101.
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址：北京市海淀区学院路29号 邮编：100083 电话：办公室：(+86 10)66554848；文献借阅、咨询服务、科技查新：66554700 |