关键词: 药品, 临床试验, 受试者

Abstract: Objective To introduce the general situation of the examination mechanism of Japanese drug clinical trial and put forward some preliminary suggestions for the review of the mechanism of drug clinical trial in China. Methods The relevant laws and regulations of Japanese drug clinical trials were reviewed, and the differences between Japanese and Chinese drug clinical trial review mechanism were studied by literature research and comparative method. Results &Conclusion By comparing, it was found that the Japanese clinical trial review was divided into the main review process and the corresponding supporting mechanism. This management mechanism can speed up the review of the Japanese drug market speed and reduce the administrative burden, it is worth our reference.

Key words: drug, clinical trial, subject