药物临床试验伦理审查前置实践与探讨

Practice and Discussion on Ethical Pre-Review of Drug Clinical Trials

新修订的《中华人民共和国药品管理法》的正式实施,明确了国家鼓励新药研发和创新,强调优化审批流程,加速新药上市。作为药物临床试验启动阶段的一个重要环节,伦理审查的时效性和审查质量也越来越受到关注。详细阐述了伦理审查前置的定义、优势和需要关注的问题,并结合自身所在医院伦理审查前置的情况,详细给出了应对上述问题的策略和建议。建议根据中国目前伦理委员会的现状,伦理审查和技术审核同步进行的同时,申办方充分考虑双方审查意见,并需要同时获得国家药品监督管理局药品评审中心批准和北京大学肿瘤医院中心伦理委员会批准后方可启动药物临床试验。

With the implementation of the newly revised“Law of the People’s Republic of China on Pharmaceutical Administration”,it’s clear that the state encourages the invention and innovation of new drugs,emphasizes on optimizing the approval process and accelerates the marketing of new drugs.The timeliness and quality of ethical review,as an important link in the start-up stage of drug clinical trials,has also attracted more and more attention.This paper elaborates the definition,advantages and concerns of the ethical pre-review,and combined with the situation of ethical pre-review in the hospital,gives the countermeasures and suggestions to deal with the above problems in detail.It is suggested that according to the current situation of the ethics committee in China,when the ethical review and technical review are carried out at the same time,the sponsor should fully consider the review opinions of both parties,and start the drug clinical trial after obtaining the approval of Center for Drug Evaluation,National Medical Products Administration and the ethics committee of the center.