國家藥品評價性抽驗管理制度研究
發(fā)布時間：2019-01-19 08:26
【摘要】：藥品是一種特殊商品,它關(guān)乎人民的生命。我國藥企眾多,藥品品種數(shù)量龐大,但簡單重復(fù)者居多,技術(shù)水平并不盡如人意。面對藥品質(zhì)量參差不齊的現(xiàn)狀應(yīng)如何應(yīng)對,給藥品監(jiān)管部門以及其技術(shù)支撐部門——藥品檢驗機構(gòu)帶來了巨大的挑戰(zhàn)。近年出臺的國家藥品評價性抽驗制度恰逢其時,對評價和把握我國藥品的整體質(zhì)量水平起到了重要作用。但也應(yīng)指出,該制度在執(zhí)行多年之后,也暴露出了一些問題。如何更好地開展國家藥品評價性抽驗工作,對該項制度進行優(yōu)化和改進顯得迫在眉睫。本研究便是對該制度系統(tǒng)梳理,提出制度改進的建議和對策。本研究以科學(xué)檢驗精神和質(zhì)量源于設(shè)計作為理論依據(jù),探討如何改進和完善我國的評價性抽驗管理制度,使之能夠更好地發(fā)揮作用,提高藥品監(jiān)管的水平,最終能夠做到保障人民用藥安全。本研究采用問卷調(diào)查方法,通過對藥品檢驗機構(gòu)和藥品企業(yè)從事評價性抽驗的一線實驗人員、職能科室主任、業(yè)務(wù)主管領(lǐng)導(dǎo)的問卷調(diào)查,闡明這兩個主體對國家評價性抽驗政策的態(tài)度與觀點,得出國家藥品評價性抽驗制度存在的部分問題和一些改進的建議。采用文獻以及比較研究方法,詳細(xì)介紹了歐盟集中審批藥品抽驗制度的相關(guān)內(nèi)容,并比較了該項制度與我國藥品評價性抽驗制度的異同,使我們能夠?qū)ζ淅砟詈头椒ḿ右越梃b。采用案例研究方法,對評價性抽驗工作的具體個例--硝酸甘油片和硝酸甘油注射液的評價性抽驗工作進行詳細(xì)的闡述,從中可以看出評價性抽驗這一政策起到的一些作用和存在的諸如樣品保障、結(jié)果利用等方面的問題。本研究的結(jié)果表明,國家藥品評價性抽驗政策在制度上確實存在著問題,對本制度加以修改是十分必要的�；诳茖W(xué)檢驗精神和質(zhì)量源于設(shè)計這兩大理論依據(jù),提出改進建議如下：1.在評價性抽驗的計劃環(huán)節(jié)進行科學(xué)設(shè)計,應(yīng)合理確定好抽驗品種的種類和數(shù)量并提前做好實驗設(shè)計工作；積極調(diào)動藥品企業(yè)的配合意愿,使企業(yè)能夠配合好本項工作；還應(yīng)做好國際交流工作,充分借鑒和參考國外類似工作的經(jīng)驗。2.在評價性抽驗的抽樣環(huán)節(jié)做好規(guī)范和保障工作,做到減輕企業(yè)負(fù)擔(dān)、不影響市場供應(yīng)和確保樣品寄送質(zhì)量。3.在評價性抽驗的實驗環(huán)節(jié)合理規(guī)劃,應(yīng)做好企業(yè)調(diào)研工作、設(shè)計好實驗周期、做好實驗數(shù)據(jù)的處理與統(tǒng)計,還應(yīng)考慮增加承檢主體,提高工作效率和質(zhì)量。4.在評價性抽驗的結(jié)果利用環(huán)節(jié)做到充分,應(yīng)使抽驗工作的結(jié)果能夠與其他相關(guān)工作轉(zhuǎn)化,應(yīng)能夠讓藥品監(jiān)管部門和藥品企業(yè)利用結(jié)果,建設(shè)可以讓各地藥品監(jiān)管機構(gòu)瀏覽參考的數(shù)據(jù)共享平臺,使結(jié)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.
【學(xué)位授予單位】：沈陽藥科大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2015
【分類號】：R95
本文編號：2411182
[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.
【學(xué)位授予單位】：沈陽藥科大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2015
【分類號】：R95
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