四川药品再注册现状分析及管理规范化对策研究
发布时间：2019-03-07 22:55
【摘要】：目的：针对四川药品再注册的现状,及其特性,正确理解和深刻认识再注册工作的意义,提高我省药品再注册工作水平,促进药品再注册监管的制度化、规范化、科学化,推动生产医药经济的可持续发展。方法：通过研究国内外再注册相关法律规定,查阅相关文献资料,调查四川省药品再注册相关结构情况,包括批准文号数量、品种分布及生产情况等内容。参加省级药品监管部门的药品再注册相关实践活动,认真分析四川省药品再注册现状及存在问题,探讨制约药品再注册监管及四川药品发展的因素,针对四川药品再注册监管实际和新时期医药产业的发展趋势,提出四川药品再注册监管体系建设思路及医药产业发展的对策。结果：通过多方面研究,四川药品再注册存在机遇与挑战。四川省具有品种资源优势,通过再注册品种获得批文多、剂型齐全、独家产品多。但企业生产品种数量不多,剂型重复的严重,药品品种结构不合理；药品企业药品注册管理机构不全,专门技术人员缺乏；企业负责药品注册岗位人员不稳定；企业品种过期申报情况突出等因素严重影响四川省药品再注册监管规范化的进程。结论：要想尽快规范四川药品再注册监管,必须打破这些制约因素,明确“销售和临床使用情况”总结报告内容；规范企业生产行为,增强企业产品质量意识；创新四川药品再注册管理方法,探索新的管理模式；加强政府职能监管力度,充分发挥政府对药品注册质控的指导作用；强化企业生产药品ADR监测报告制度,增强企业自身监管责任意识；创新药品Ⅳ期临床试验监管机制,实施上市后药品质量监测目标；构建药品再注册信息平台,改革和完善审评程序,提高审批质量与水平；改革和完善审评程序,试行分时、分类、分批进行审批；构建药品再注册信息平台,增强审批工作公信力；加快企业药品注册专门机构建设,加强专业技术人才培养；建立药品再注册安全问责制。
[Abstract]:Objective: in view of the current situation and characteristics of drug re-registration in Sichuan, correctly understand and deeply understand the significance of re-registration, improve the level of drug re-registration in our province, and promote the institutionalization, standardization and science of drug re-registration supervision. To promote the sustainable development of the production medicine economy. Methods: by studying the relevant laws and regulations of re-registration at home and abroad, consulting the relevant documents and materials, investigating the related structure of drug re-registration in Sichuan province, including the number of approved documents, the distribution of varieties and the production situation and so on. To participate in the practice activities of drug re-registration of provincial drug regulatory departments, analyze the current situation and existing problems of drug re-registration in Sichuan Province, and discuss the factors that restrict the supervision of drug re-registration and the development of drugs in Sichuan Province. In view of the practice of drug re-registration supervision in Sichuan and the development trend of medicine industry in the new period, this paper puts forward the idea of establishing the supervision system of drug re-registration in Sichuan and the countermeasures for the development of medicine industry. Results: there were opportunities and challenges in drug re-registration in Sichuan. Sichuan Province has the advantage of variety resources, through re-registration of varieties to obtain more approval, complete dosage form, exclusive products. However, the number of varieties produced by enterprises is small, the dosage forms are repeated seriously, the structure of drug varieties is unreasonable, the drug registration and administration institutions of pharmaceutical enterprises are not complete, and the specialized technical personnel are lacking, the personnel in charge of drug registration posts in enterprises are not stable; The outstanding status of overdue declaration of enterprise varieties seriously affects the standardization of drug re-registration supervision in Sichuan Province. Conclusion: in order to regulate the supervision of drug re-registration in Sichuan province as soon as possible, it is necessary to break these restriction factors, make clear the summary contents of "sales and clinical use", standardize the production behavior of enterprises and enhance the consciousness of product quality of enterprises. To innovate the management method of drug re-registration in Sichuan, to explore the new management mode, to strengthen the supervision and control of government functions, to give full play to the guiding role of the government in the quality control of drug registration; We should strengthen the monitoring and reporting system of drug production ADR, strengthen the consciousness of self-supervision responsibility of enterprises, innovate the supervision mechanism of drug phase IV clinical trial, and implement the monitoring target of drug quality after market. Construct the information platform of drug re-registration, reform and perfect the procedure of review, improve the quality and level of examination and approval, reform and perfect the procedure of review, try out time-sharing, classify and approve in batches. We should build the information platform for drug re-registration to enhance the credibility of the examination and approval work, speed up the construction of specialized organizations for drug registration in enterprises, strengthen the training of professional and technical personnel, and establish an accountability system for drug re-registration safety.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95
本文编号：2436534
[Abstract]:Objective: in view of the current situation and characteristics of drug re-registration in Sichuan, correctly understand and deeply understand the significance of re-registration, improve the level of drug re-registration in our province, and promote the institutionalization, standardization and science of drug re-registration supervision. To promote the sustainable development of the production medicine economy. Methods: by studying the relevant laws and regulations of re-registration at home and abroad, consulting the relevant documents and materials, investigating the related structure of drug re-registration in Sichuan province, including the number of approved documents, the distribution of varieties and the production situation and so on. To participate in the practice activities of drug re-registration of provincial drug regulatory departments, analyze the current situation and existing problems of drug re-registration in Sichuan Province, and discuss the factors that restrict the supervision of drug re-registration and the development of drugs in Sichuan Province. In view of the practice of drug re-registration supervision in Sichuan and the development trend of medicine industry in the new period, this paper puts forward the idea of establishing the supervision system of drug re-registration in Sichuan and the countermeasures for the development of medicine industry. Results: there were opportunities and challenges in drug re-registration in Sichuan. Sichuan Province has the advantage of variety resources, through re-registration of varieties to obtain more approval, complete dosage form, exclusive products. However, the number of varieties produced by enterprises is small, the dosage forms are repeated seriously, the structure of drug varieties is unreasonable, the drug registration and administration institutions of pharmaceutical enterprises are not complete, and the specialized technical personnel are lacking, the personnel in charge of drug registration posts in enterprises are not stable; The outstanding status of overdue declaration of enterprise varieties seriously affects the standardization of drug re-registration supervision in Sichuan Province. Conclusion: in order to regulate the supervision of drug re-registration in Sichuan province as soon as possible, it is necessary to break these restriction factors, make clear the summary contents of "sales and clinical use", standardize the production behavior of enterprises and enhance the consciousness of product quality of enterprises. To innovate the management method of drug re-registration in Sichuan, to explore the new management mode, to strengthen the supervision and control of government functions, to give full play to the guiding role of the government in the quality control of drug registration; We should strengthen the monitoring and reporting system of drug production ADR, strengthen the consciousness of self-supervision responsibility of enterprises, innovate the supervision mechanism of drug phase IV clinical trial, and implement the monitoring target of drug quality after market. Construct the information platform of drug re-registration, reform and perfect the procedure of review, improve the quality and level of examination and approval, reform and perfect the procedure of review, try out time-sharing, classify and approve in batches. We should build the information platform for drug re-registration to enhance the credibility of the examination and approval work, speed up the construction of specialized organizations for drug registration in enterprises, strengthen the training of professional and technical personnel, and establish an accountability system for drug re-registration safety.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95
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