摘要
随着药品审评审批制度改革和临床试验数据核查工作的持续推进,新修订的《中华人民共和国药品管理法》、《药品注册管理办法》和《药物临床试验质量管理规范》等一系列药品注册领域法律法规文件的颁布实施,药物临床试验现场核查关注点发生变化。笔者结合药物临床试验数据核查工作实际,以现行法规文件为指导,从临床试验的软硬件与合规性条件、伦理审查、临床试验实施过程、试验用药品的管理、生物样本管理与中心实验室、临床试验数据的采集和管理6个方面,对药物临床试验现场核查的关注点及常见问题进行梳理分析,为加强药物临床试验全过程的质量管理提供建议。
With the continuous advancement of the reform of the drug review and approval system and on-site inspection of clinical trial data, a series of laws and regulations in the field of drug registration were newly revised, including "The Pharmaceutical Administration Law of the People’s Republic of China", "Provisions of Drug Registration" and "Good Clinical Practice of Pharmaceutical Products". With the issuance and implementation of the document, the focus of on-site inspection of drug clinical trials had changed. This article combines the regulatory experience of drug clinical trial data onsite inspection, guided by current regulations and documents, sorted in 6 aspects, including the software and hardware of clinical trials and compliance conditions, ethical review, the implementation and process of clinical trials, the management of investigational drug products, the management of biological samples/central laboratory, the collection and management of clinical trial data. The focus and common problems of on-site inspection of drug clinical trials are sorted out and analyzed, in order to provide suggestions for drug clinical trial quality management.
作者
李小芬
吴莹
李刚
LI Xiao-fen;WU Ying;LI Gang(Shanghai Center for Drug Evaluation and Inspection,SHANGHAI 201203,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2021年第9期638-642,共5页
Chinese Journal of New Drugs and Clinical Remedies
关键词
药物临床试验质量管理规范
药物批准
临床试验
组织和管理
good clinical practice of pharmaceutical products
drug approval
clinical trial
organization and administration
