中药创新药申请临床试验药学申报资料的相关考虑  

Relevant Considerations on CMC Dossiers for Clinical Trial Applications of Innovative Traditional Chinese Medicine

作　　者：吴晨悦 曲建博[1] 马秀璟[1] WU Chen-yue;QU Jian-bo;MA Xiu-jing(Center for Drug Evaluation,NMPA)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2022年第4期30-34,共5页China Food & Drug Administration Magazine

摘　　要：新版《药品注册管理办法》已颁布实施,其配套文件《中药注册分类及申报资料要求》与原《药品注册管理办法》附件1《中药、天然药物注册分类及申报资料要求》相比,从内容到体例均发生较大变化。本文比较了新旧法规中药注册分类和申报资料要求的变化,以1.1类中药复方制剂为例,指出临床试验申请时需要关注的药学问题,对中药创新药申请临床试验时药学申报资料撰写提出建议,以期引导申请人适应新变化、符合新要求、规范资料撰写,提高中药创新药的申报质量和效率。The new Provisions for Drug Registration has been issued and implemented.Compared with Annex I:Requirements for Registration Classification and Application Dossier of Traditional Chinese Medicine(TCM)and Natural Medicine of the previous Provisions for Drug Registration,the new Provisions’supporting document Requirements for Registration Classification and Application Dossier of TCM has undergone major changes in both content and format.In order to guide applicants to adapt to the new changes,meet new requirements,standardize preparation of the dossier,and improve the quality and efficiency for clinical trial applications of innovative TCM,this paper compares the changes in requirements for registration classification and application dossier between the current and previous regulations.Taking TCM compound preparations of Category 1.1 as an example,the authors point out the main problems found during the review process,and put forward suggestions on the preparation of CMC dossiers when applying for clinical trials of innovative TCM.

关 键 词：中药创新药 临床试验申请 药学申报资料 

分 类 号：R95[医药卫生—药学]