2011—2017年中国中药新药注册申请分析

Analysis of Registration for New Chinese Herbal Drug from 2011-2017

本文通过对国务院药品监督管理部门公开数据库中2011—2017年中药新药注册申报情况进行整理,并对申报品种数量、分类情况和剂型选择按年度进行了系统对比,尝试剖析其中可能存在的潜在规律及成因。按照当前的中药注册分类,6类新药是药品生产企业研发的重点。在剂型选择上,颗粒剂、胶囊剂和片剂占到总申报数量的75.98%。随着《中华人民共和国中医药法》的实施和药品审评审批制度改革的深化,以临床价值为导向的药物创新将成为中药新药研发和注册审评标准的关键点。

The article analyzes the data of new Chinese herbal drug registration which received by Center for Drug Evaluation（ CDE）,China Food and Drug Administration during 2011-2017. Through database retrieval,the amount,classification and formulation selection of new Chinese herbal drug registrations were acquainted. Then the inherent laws and their cause were analyzed. According to the numerical calculating results,the main applications belonged to the sixth register classification. In formulation selection,granules,capsule,and tablet account for 75. 98% of the total number of declaration. With promulgation of Law of the People＇s Republic of China on Traditional Chinese Medicine,and reformation of drug registration system,clinical value will become the most important evaluation standard in new drug research and registration review.