2014-2018年我国中成药说明书修订公告及备案信息分析

Analysis of Leaflets’ Revision Announcements and Record Information of Chinese Patent Drugs in 2014-2018

目的分析中成药说明书修订公告安全性信息,结合备案公示信息分析中成药安全性信息监管现状和监管措施的落实情况,为中成药上市后监管提供依据。方法通过收集整理2014-2018年国家药品监督管理局公开发布的中成药说明书修订公告,对安全性信息进行统计分析;继而查阅备案信息,比对说明书修订公告要求与说明书安全性信息变更备案情况。结果共收集中成药说明书修订公告相关品种101个,涉及【不良反应】修订的品种占91.09%,【禁忌】修订占93.07%,【注意事项】修订占99.01%。根据修订公告企业备案率达100%的药品占36.80%;备案率50%~86%的药品占32.80%;备案率9%~49%的药品占12.00%;18.40%的药品未见相关企业备案信息。结论中成药的监管措施还没有完全按时限按规定落实。药品生产企业应充分发挥药品安全主体责任,严格按照监管要求履行职责,控制风险,保证公众用药安全。

OBJECTIVE To analyze the safety information in leaflets’ revision announcement of Chinese patent drugs, and analyze the current supervisory situation of leaflets’ safety information and the implementation of supervision measures combined with the public record information, so as to provide basis for post-marketing surveillance of Chinese patent drugs. METHODS Making statistics and analysis of safety information by collecting and sorting out the leaflets’ revision announcements of Chinese patent drugs published by National Medical Products Administration in 2014-2018. Then collected the public record information and compared with the requirements of revision announcements. RESULTS The 101 varieties of Chinese patent drugs were collected, 91.09%, 93.07% and 99.01% varieties were respectively involved in revision of "adverse reactions" "contraindications" and "precautions". The record rates of 36.80% varieties reached 100%, the record rates of 32.80% varieties were 50%-86%, the record rates of 12.00% varieties were 9%-49%, 18.40% varieties had not received any record information. CONCLUSION The regulatory measures of Chinese patent drugs have not been fully implemented. Manufactures should take full responsibility for drug safety, perform duties strictly as requested, control risks and ensure the safety use of drugs.