Requirement for Ethics Committee after China Food and Drug Administration Join ICH-GCP
10.12026/j.issn.1001-8565.2017.12.14
- VernacularTitle:我国国家食品药品管理总局加入ICH-GCP对伦理委员会的要求
- Author:
Jiyin ZHOU
1
;
Dan LIU
;
Shengya ZENG
;
Laixin ZHOU
Author Information
1. 陆军军医大学第二附医院属国家药物临床试验机构
- Keywords:
Ethics Committee;
Standardization Construction;
Review Ability;
CFDA;
ICH-GCP
- From:
Chinese Medical Ethics
2017;30(12):1512-1516
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.
