CAJ | 학술논문

从研发到上市，新药的临床安全性信息是一个不断积累和更新的过程。从早期研发阶段、临床试验过程、乃至批准上市后，在药品的整个生命周期，申请人负有对安全性信息的收集、整理、分析、报告、更新以及提出处理建议的责任。对监管机构来说，安全性信息的收集、更新和管理是贯穿药品整个生命周期的风险管理措施的重要部分。本文对新药审评中遇到的药品临床安全性信息更新和管理的案例进行分析，对国内外的管理现状和存在的问题进行讨论，为进一步完善药品管理提供启发和借鉴。
종연발도상시，신약적림상안전성신식시일개불단적루화경신적과정。종조기연발계단、림상시험과정、내지비준상시후，재약품적정개생명주기，신청인부유대안전성신식적수집、정리、분석、보고、경신이급제출처리건의적책임。대감관궤구래설，안전성신식적수집、경신화관리시관천약품정개생명주기적풍험관리조시적중요부분。본문대신약심평중우도적약품림상안전성신식경신화관리적안례진행분석，대국내외적관리현상화존재적문제진행토론，위진일보완선약품관리제공계발화차감。
Clinical safety information of a new drug is increasingly accu-mulating and updating during from the beginning of research to the new drug approval.The applicant is responsible for the collection, analysis , report, update of the clinical safety information.Furthermore, sugges-tions on related management measures should be raised if necessary.The safety information administration should cover the whole lifecycle of a drug. On the other aspect, clinical safety information update and management is an essential component of risk control measures of drug regu-latory agencies.The article discussed on the examples on new drug clinical safety information update and management measures at home and abroad.