【摘要】：目的：針對四川藥品再注冊的現(xiàn)狀,及其特性,正確理解和深刻認識再注冊工作的意義,提高我省藥品再注冊工作水平,促進藥品再注冊監(jiān)管的制度化、規(guī)范化、科學化,推動生產(chǎn)醫(yī)藥經(jīng)濟的可持續(xù)發(fā)展。方法：通過研究國內(nèi)外再注冊相關法律規(guī)定,查閱相關文獻資料,調查四川省藥品再注冊相關結構情況,包括批準文號數(shù)量、品種分布及生產(chǎn)情況等內(nèi)容。參加省級藥品監(jiān)管部門的藥品再注冊相關實踐活動,認真分析四川省藥品再注冊現(xiàn)狀及存在問題,探討制約藥品再注冊監(jiān)管及四川藥品發(fā)展的因素,針對四川藥品再注冊監(jiān)管實際和新時期醫(yī)藥產(chǎn)業(yè)的發(fā)展趨勢,提出四川藥品再注冊監(jiān)管體系建設思路及醫(yī)藥產(chǎn)業(yè)發(fā)展的對策。結果：通過多方面研究,四川藥品再注冊存在機遇與挑戰(zhàn)。四川省具有品種資源優(yōu)勢,通過再注冊品種獲得批文多、劑型齊全、獨家產(chǎn)品多。但企業(yè)生產(chǎn)品種數(shù)量不多,劑型重復的嚴重,藥品品種結構不合理；藥品企業(yè)藥品注冊管理機構不全,專門技術人員缺乏；企業(yè)負責藥品注冊崗位人員不穩(wěn)定；企業(yè)品種過期申報情況突出等因素嚴重影響四川省藥品再注冊監(jiān)管規(guī)范化的進程。結論：要想盡快規(guī)范四川藥品再注冊監(jiān)管,必須打破這些制約因素,明確“銷售和臨床使用情況”總結報告內(nèi)容；規(guī)范企業(yè)生產(chǎn)行為,增強企業(yè)產(chǎn)品質量意識；創(chuàng)新四川藥品再注冊管理方法,探索新的管理模式；加強政府職能監(jiān)管力度,充分發(fā)揮政府對藥品注冊質控的指導作用；強化企業(yè)生產(chǎn)藥品ADR監(jiān)測報告制度,增強企業(yè)自身監(jiān)管責任意識；創(chuàng)新藥品Ⅳ期臨床試驗監(jiān)管機制,實施上市后藥品質量監(jiān)測目標；構建藥品再注冊信息平臺,改革和完善審評程序,提高審批質量與水平；改革和完善審評程序,試行分時、分類、分批進行審批；構建藥品再注冊信息平臺,增強審批工作公信力；加快企業(yè)藥品注冊專門機構建設,加強專業(yè)技術人才培養(yǎng)；建立藥品再注冊安全問責制。
[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.
【學位授予單位】：成都中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R95

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