药物临床试验机构备案制实施的阻碍与解决对策-中国药房

药物临床试验机构备案制实施的阻碍与解决对策

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篇名：	药物临床试验机构备案制实施的阻碍与解决对策
TITLE：
摘要：	目的：为药物临床试验机构备案管理的顺利实施提供建议。方法：通过查阅相关公告、文件及文献，分析药物临床试验机构备案制实施过程中存在的障碍并提出解决对策。结果与结论：药物临床试验机构备案制实施过程中主要存在药物临床试验机构备案管理相关法规缺失、药物临床试验过程监管缺失、监管机构及其职能不明确、非“三甲”医院在建立临床试验机构上面临软硬件建设不足的现状、药物临床试验机构的内部管理弱化、备案制后申办方对临床试验机构的需求仍将集中在少数大型医院等问题。基于此，笔者建议国家相关部门尽快完善《中华人民共和国药品管理法》并出台相关规章及实施细则，明确相关监管机构及其职能（如国家药品监督管理局会同国家卫生健康委员会制订临床试验机构监管的相关的法规规章，国家药品监督管理局审核查验中心负责建立药物临床试验机构评价指标体系、评价标准以及过程监管的检查细则，过程监管由省级药品监督管理局等部门负责），政府建立内外联动机制积极建设药物临床试验机构并维持其有效运营，通过领导重视、制订内部章程、加强内部培训和机构间交流学习等方式加强临床试验机构的内部管理，并合理分工，根据医疗卫生机构的技术水平开展差异化的服务吸引申办方，在国家药品监督管理局备案系统中按机构的能力和类型加以分类、公开并鼓励申办方选择适宜的机构开展药物临床试验，以此保障药物临床试验机构备案管理的顺利实施。
ABSTRACT：	OBJECTIVE： To provide the suggestions for the smooth implementation of record-keeping system in drug clinical trial institutions. METHODS： The obstacles in the implementation of the record-keeping system of drug clinical trial institutions were analyzed to put forward countermeasures according to search related announcement， document and literature. RESULTS & CONCLUSIONS： In the process of implementing the record-keeping system of drug clinical trial institutions， there are mainly deficiencies in the relevant laws and regulations of the record-keeping management of drug clinical trial institutions， the supervision of the process of drug clinical trial， the unclear functions of regulatory bodies， lack of hardware and saftware status quo that clinical tral institution construction in non “third grade class A” hospitals， the weakening of the internal management of drug clinical trial institutions， and the bidders’ demand for clinical trial institutions concentrated in a few large hospitals after the implementation of record-keeping system. Based on this， the author suggests that the relevant state departments should improve the Drug Administration Law of the People’s Republic of China as soon as possible and promulgate relevant regulations and implementation rules to clarify the relevant regulatory bodies and their functions （such as State Drug Administration， in conjunction with the State Health Commission， formulates relevant laws and regulations for the supervision of clinical trial institutions； National Medical Products Administration is responsible for establishing an evaluation index system for drug clinical trial institutions； provincial drug administration and other departments are responsible for the evaluation criteria， inspection rules and process supervision）. The government has established an internal and external linkage mechanism to actively build and maintain the effective operation of drug clinical trial institutions. The internal management of clinical trial institutions can be strengthened and the division of labor can be rationalized by means of leadership attention， formulation of internal charters， strengthening internal training and inter-agency communication and learning； according to the technical level of medical and health institutions， differentiated services was provided to attract bidders； the capabilities and types of the institutions in the record-keeping system of National Medical Products Administration should be classified and publicized； bidders should be encouraged to select suitable institutions for drug clinical trials so as to guarantee smooth implementation of record-keeping management in drug clinical trial institutions.
期刊：	2019年第30卷第13期
作者：	张旭，田丽娟
AUTHORS：	ZHANG Xu，TIAN Lijuan
关键字：	临床试验机构；备案制；实施；阻碍；对策
KEYWORDS：	Clinical trial institution； Record-keeping system； Implementation； Obstacles； Countermeasures
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