Enlightenment of Japan expanded access clinical trial system to China’s compassionate drug use system
- VernacularTitle:日本拓展性临床试验制度对我国同情用药制度的启示
- Author:
Qian WANG
1
;
Yu YIN
1
;
Feng JIANG
1
;
Kan TIAN
2
;
Xiaoyong YU
2
;
Haoyu YANG
1
Author Information
1. School of Health Economics and Management，Nanjing University of Chinese Medicine，Nanjing 210023，China
2. College of Elderly Care Service and Management，Nanjing University of Chinese Medicine，Nanjing 210023，China
- Publication Type:Journal Article
- Keywords:
expanded access clinical trial system;
compassionate drug use system;
drug accessibility;
Japan
- From:
China Pharmacy
2023;34(9):1038-1041
- CountryChina
- Language:Chinese
-
Abstract:
The system of compassionate drug use in China is in the preliminary exploration stage， and the formal management methods and specific implementation rules have not been promulgated， which needs to be further optimized and perfected. Japan realizes the advanced use of unapproved drugs by expanded access clinical trial system， and makes clear provisions on information acquisition， target patient， informed consent， subject of application， implementation plan， handling of refusal to administer medication， drug expenses， implementation deadline， compensation for accidental damages， post-approval data review after expanded access clinical trials. When the enterprise refuses to give drugs because of the “legitimacy reasons of the system”， the attending physician can also apply to the Ministry of Health， Labor and Welfare， and the Ministry of Health， Labor and Welfare will conduct the licensing evaluation to maximize the drug for patients. This “refusal to administer” reprocessing is a unique regulation in Japan， which ensures the accessibility of drugs to the greatest extent possible. Based on the analysis of the expanded access clinical trial system in Japan， it is found that our country could further build the information platform for compassionate drug use， play the leading role of physicians， protect the interests of enterprises， pay attention to the ethical review， and make drug cost payment problems further clear in order to improve and optimize the system of compassionate drug use.
