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巻頭言 医薬品・医療機器などの開発における国際協力

独立行政法人医薬品医療機器総合機構 理事長


重慶医科大学薬学院薬品政策・評価研究センター 准教授
鄭 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


梁愛華※1  潘 辰 韓佳寅 田婧卓
※1 研究員、実験室主任(責任著者)

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


株式会社医療システム研究所 治験推進本部 取締役本部長
東京薬科大学 非常勤講師
和洋女子大学看護学部 客員講師

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 サービシーズ ジャパン株式会社 シニアディレクター

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



名古屋大学 名誉教授

笹川生 in China

復旦大学附属華東病院呼吸器・重症医療科 主任医師

あとがき 広報委員会委員  平野俊彦