Research Ⅰ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:The Enlightenment of Japanese Requirements for Drug Clinical Trials and Change Management during Clinical Trials on Improving China's Regulatory System
Objective:To study the regulatory requirements and implementation of the change management during the clinical research of drugs in Japan,and compare it with the current construction and implementation status of relevant regulatory regulations in China,in order to provide reference for improving the regulatory system of the change management of sponsors and production sites during the clinical research of drugs in China.Methods:A systematic review and study of regulatory regulations on the change of sponsors and production sites during the clinical research in Japan was conducted.Suggestions were provided based on the current situation of change management during the clinical research in China.Results and Conclusion:In Japan,the clinical trial sponsors and clinical trial drug production sites are allowed to apply for registration and change of clinical trials both domestically and internationally.The regulatory measures in the Japanese regulatory system are of reference value to China,such as"domestic agent system for fulfilling responsibilities and obligations,comprehensive and efficient advisory services,and worldwide regulatory inspections covering the whole process".
clinical trialchange managementsponsor changeproduction site changedrug administration