国家药品评价性抽验管理制度研究

发布时间：2019-01-19 08:26

【摘要】：药品是一种特殊商品,它关乎人民的生命。我国药企众多,药品品种数量庞大,但简单重复者居多,技术水平并不尽如人意。面对药品质量参差不齐的现状应如何应对,给药品监管部门以及其技术支撑部门——药品检验机构带来了巨大的挑战。近年出台的国家药品评价性抽验制度恰逢其时,对评价和把握我国药品的整体质量水平起到了重要作用。但也应指出,该制度在执行多年之后,也暴露出了一些问题。如何更好地开展国家药品评价性抽验工作,对该项制度进行优化和改进显得迫在眉睫。本研究便是对该制度系统梳理,提出制度改进的建议和对策。本研究以科学检验精神和质量源于设计作为理论依据,探讨如何改进和完善我国的评价性抽验管理制度,使之能够更好地发挥作用,提高药品监管的水平,最终能够做到保障人民用药安全。本研究采用问卷调查方法,通过对药品检验机构和药品企业从事评价性抽验的一线实验人员、职能科室主任、业务主管领导的问卷调查,阐明这两个主体对国家评价性抽验政策的态度与观点,得出国家药品评价性抽验制度存在的部分问题和一些改进的建议。采用文献以及比较研究方法,详细介绍了欧盟集中审批药品抽验制度的相关内容,并比较了该项制度与我国药品评价性抽验制度的异同,使我们能够对其理念和方法加以借鉴。采用案例研究方法,对评价性抽验工作的具体个例--硝酸甘油片和硝酸甘油注射液的评价性抽验工作进行详细的阐述,从中可以看出评价性抽验这一政策起到的一些作用和存在的诸如样品保障、结果利用等方面的问题。本研究的结果表明,国家药品评价性抽验政策在制度上确实存在着问题,对本制度加以修改是十分必要的。基于科学检验精神和质量源于设计这两大理论依据,提出改进建议如下：1.在评价性抽验的计划环节进行科学设计,应合理确定好抽验品种的种类和数量并提前做好实验设计工作；积极调动药品企业的配合意愿,使企业能够配合好本项工作；还应做好国际交流工作,充分借鉴和参考国外类似工作的经验。2.在评价性抽验的抽样环节做好规范和保障工作,做到减轻企业负担、不影响市场供应和确保样品寄送质量。3.在评价性抽验的实验环节合理规划,应做好企业调研工作、设计好实验周期、做好实验数据的处理与统计,还应考虑增加承检主体,提高工作效率和质量。4.在评价性抽验的结果利用环节做到充分,应使抽验工作的结果能够与其他相关工作转化,应能够让药品监管部门和药品企业利用结果,建设可以让各地药品监管机构浏览参考的数据共享平台,使结果利用最大化。
[Abstract]:Medicine is a special commodity, it is related to the life of the people. There are many pharmaceutical enterprises in our country, and the number of drug varieties is huge, but the simple repetition is the most, and the technical level is not satisfactory. How to deal with the uneven quality of drugs has brought great challenges to the drug supervision department and its technical support organization. The national drug evaluation sampling system introduced in recent years has played an important role in evaluating and grasping the overall quality level of Chinese drugs. But it should also be pointed out that after years of implementation, the system also exposed some problems. How to better carry out the national drug evaluation sampling work, it is urgent to optimize and improve the system. This research is a systematic analysis of the system, put forward suggestions and countermeasures to improve the system. Based on the scientific inspection spirit and quality design as the theoretical basis, this study discusses how to improve and perfect the evaluation sampling inspection management system in China, so that it can play a better role and improve the level of drug supervision. Finally, it can ensure the safety of drug use. This research adopts the questionnaire survey method, through to the drug inspection organization and the medicine enterprise engaged in the appraisal sample inspection the first line laboratory personnel, the function department director, the business supervisor leadership questionnaire survey, This paper expounds the attitudes and viewpoints of these two subjects towards the national evaluation sampling inspection policy, and draws some problems and some suggestions for improvement of the national drug evaluation sampling system. By using literature and comparative research methods, this paper introduces in detail the relevant contents of the European Union's centralized drug examination and approval system, and compares the similarities and differences between this system and our country's drug evaluation sampling inspection system, so that we can draw lessons from its ideas and methods. With the method of case study, the evaluation sampling work of nitroglycerin tablets and nitroglycerin injection is described in detail. It can be seen that the policy of evaluative sampling has some functions and problems such as sample guarantee and result utilization. The results of this study show that there are some problems in the system of the national drug evaluation sampling policy, and it is necessary to modify the system. Based on the scientific inspection spirit and quality from the design of the two theoretical basis, put forward suggestions for improvement as follows: 1. In order to carry out scientific design in the planning link of evaluation sampling inspection, we should reasonably determine the types and quantity of the sample inspection varieties and do well the experimental design work in advance, and actively mobilize the cooperation will of the pharmaceutical enterprises so that the enterprises can cooperate well with this work; We should also do a good job in international exchanges and fully learn from and refer to the experience of similar work abroad. 2. The standard and guarantee work should be done in the sampling link of evaluation sampling, so as to lighten the burden of enterprises, not affect the market supply and ensure the quality of sample delivery. In the rational planning of the experimental links of evaluation sampling inspection, we should do a good job in enterprise investigation, design the experiment cycle, do well the processing and statistics of the experimental data, and consider increasing the subject of inspection and improving the efficiency and quality of the work. 4. In order to make full use of the results of the evaluation sampling, the results of the sampling and inspection should be transformed with other relevant work, and the pharmaceutical supervision department and the pharmaceutical enterprises should be able to use the results. Build a data-sharing platform that allows local drug regulators to browse the reference data-sharing platform to maximize the use of results.
【学位授予单位】：沈阳药科大学
【学位级别】：博士
【学位授予年份】：2015
【分类号】：R95

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