FDA 505(b)(2)改良型新药的申报情况对中药改良型新药的启发思考  

Enlightenment of modified FDA 505(b)(2)application on modified traditional Chinese new drugs

作　　者：孙昱 孙国祥[2] 李焕德[3] SUN Yu;SUN Guo-xiang;LI Huan-de(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022;College of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016;The Second Xiangya Hospital of Central South University,Changsha 410013)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]沈阳药科大学药学院,沈阳110016 [3]中南大学湘雅二医院,长沙410013

出　　处：《中南药学》2021年第3期369-375,共7页Central South Pharmacy

基　　金：国家自然科学基金项目(No.81573586)。

摘　　要：本文旨在为鼓励中药改良创新,制订适当简化的技术文件提供参考。结合FDA相关指导原则和近年获批505(b)(2)新药的实际研究情况,对505(b)(2)新药申请可能需要的桥接方法、非临床/临床研究进行阐述。FDA的3种新药申报途径[505(j)ANDA、505(b)(2)NDA、505(b)(1)NDA]对应不同的技术要求。我国中药改良型新药类似于FDA改良型新药。对于中药改良型新药,建议分情况要求非临床/临床研究资料,考虑应用真实世界证据替代部分非临床的药理学研究(例如主要药效学)、非临床安全性研究以及临床安全性/有效性研究(例如2期临床试验)。This paper aims to provide reference for establishing simplified technical requirements to encourage the improvement and innovation of traditional Chinese medicine.Based on the FDA guidelines and the actual research status of 505(b)(2)new drugs approved in recent years,the bridging methods and non-clinical/clinical studies that may be required for 505(b)(2)new drug application were described.The three new drug reporting routes of FDA,namely 505(j)ANDA,505(b)(2)NDA and 505(b)(1)NDA,corresponded to different reporting requirements.The modified traditional Chinese new drugs were similar to the category of modified new drugs of FDA.For modified traditional Chinese new drug,we recommended non-clinical/clinical research data on a case-by-case basis,and real-world evidence to replace some non-clinical pharmacological studies(e.g.,primary pharmacology),nonclinical safety studies,and clinical safety/efficacy studies(e.g.,phase II clinical trials).

关 键 词：FDA 505(b)(2) 中成药 二次开发 真实世界证据 申报情况 中药改良型新药 

分 类 号：R95[医药卫生—药学]