摘要
药品研发数据是支持药品审评对药品安全性、有效性、质量可控评价的重要证据,是药品注册现场核查的重要内容。2020年7月1日《药品注册管理办法》正式生效后,药品注册核查也发生了新的变化。本文对近2年化学药品药学研制现场核查情况进行梳理,对研制现场核查要点的变化和常见问题进行分析,为新法实施后药品注册申请人加强药品研发管理提供思路。
The research and development data is the important evidence to prove the safety,effectiveness and quality control of drugs,which also is the important content in pre-approval inspection.New changes have taken place in drug pre-approval inspection after Drug Registration Administration came into force on 1 July 2020.Based on study and analysis of the observations of pre-approval inspection of chemical drugs in the past 2 years,the common problems and changes were put forward.The study provides references for registration applicants and pharmaceutical researchers to improve their quality management.
作者
胡小娟
曹轶
HU Xiao-juan;CAO Yi(Center for Food and Drug Inspection,National Medical Products Administration,Beijing 100044,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第8期783-786,共4页
Chinese Journal of New Drugs
关键词
注册核查
研制现场
常见问题
pre-approval inspection
researching and developing
common problems
