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前言 关于医药品与医疗器械研发的国际合作

独立行政法人医药品医疗器械综合机构 理事长


重庆医科大学药学院药品政策与评价研究中心 副教授
郑 航

Current Situation and Future of Drug Clinical Trial Management in China

In the background of the reform of drug review and approval system, great changes have taken place in China’s drug clinical trial management regulations. The main changes include: the change of clinical trial institutions from accreditation to fi ling system, the change of clinical trial approval from express approval system to implied approval system, and the implementation of China GCP(2020 version). The future of China’s drug clinical trial management will usher in the improvement of clinical trial quality, technical challenges and industry changes.

【Key words】
drug, clinical trial, GCP, drug clinical trial institution, license


梁爱华※1 潘 辰 韩佳寅 田婧卓
※1 研究员、实验室主任(通讯作者)

Advances of new drug research of traditional Chinese medicine in China

There is a long history of using traditional Chinese medicine(TCM)to treat diseases in China, and a large number of TCM formulas have been documented during the long-term clinical practice. These materia medica and formulas with their clinical experiences are rich resources for the development of new drugs. This article introduces the classifi cation and requirements of TCM new drugs in China, the approaches for TCM new drug discovery, and the representative new drugs of traditional Chinese Medicine, so as to provide references for new drug developers.

【Key words】
Traditional Chinese medicine, formula of traditional Chinese medicine, new drug registration, new drug research and development, classifi cation of traditional Chinese medicine


株式会社医疗系统研究所 临床试验推进总部 董事总部长
东京药科大学 编外讲师
和洋女子大学护理部 客座讲师

Current status of clinical trials and clinical research in Japan, Consideration for problems of clinical trial, and prospects 

Clinical trials in Japan, it is said to be special compared to those of Western countries and Asian countries. I would like to describe the current status and issues of clinical trials in Japan from my experience of being involved in clinical development at a pharmaceutical company, later working for SMO for many years, and serving as a lecturer at a pharmacy school and a nursing university.

【Key words】
GCP(Good Clinical Practice), Global clinical trial, clinical research coordinator, drug lag


IQVIA Services Japan 株式会社 高级总监

Clinical Drug Development and Clinical Trial:Current Status, Prospects and Challenges

There are challenges in the pharmaceutical industry. The Japanese market is experiencing negative growth and it is more difficult to approve new drugs for investment. Under these circumstances, discussions on productivity and efficiency in drug research and development are intensifying. In addition to trends such as Precision Medicine and Patient Centricity, digitalization represented by “Virtual Trial” is progressing in the implementation of clinical trials and expected to improve productivity/efficiency.

【Key words】
Clinical Trial, Productivity, Efficiency, Virtual Trial



纽 带 


笹川生 in China

复旦大学附属华东医院呼吸与危重症医学科 主任医师

后 记 宣传委员会委员  平野俊彦