摘要
我国药物临床试验机构经历了30多年的发展历程。在临床试验实施中起着重要的作用。2017年10月27日,国家食品药品监督管理总局(CFDA),发布了新的《药物临床试验机构管理规定(征求意见稿)》。较由原国家食品药品监督管理局和卫生部共同颁布《药物临床试验机构资格认定办法(试行)》,在药物临床试验机构资质申请认定和管理方面都发生了很大变化,在申请资质与途径、流程和时限、申请基本条件、违法惩处力度等方面有了新的表述。本文旨在比较前法规与新法规的相关变化并分析其发生的影响。
The clinical trial institutions in China has been developed for more than 30 years. It plays an important role in running clinical trials. On October 27, 2017, the China Food and Drug Administration （CFDA） released a new regulation ＂the Administration of Drug Clinical Trial Institutions （Draft for Comment）＂. Compared to the current effective regulation which was re/eased by the CFDA and the Ministry of Health, the ＂Measures for the Accreditation of Drug Clinical Trial Institutions （for Trial Implementation）＂, the proposed new one has great changes in the identification and management of the applying drug clinical trial institutions, reformulating such aspects as qualifications, basic requirements, approaches, process, time limits, punishments, etc. This paper aims to find out the relevant changes and to analyze their impacts.
出处
《药学与临床研究》
2018年第1期71-73,共3页
Pharmaceutical and Clinical Research
关键词
药物临床试验机构
药物临床试验机构管理规定(征求意见稿)
药事管理
影响
The Clinical Trial Institution
The Administration of Drug Clinical Trial Institutions （Draft for Comment）
Pharmacy administration
Impact
