目的 药品的安全监管是贯穿于药品的整个生命周期的,目前对生产企业药品上市后风险管理的政府监管存在不足。政府监管效果影响因素的研究可为药品上市后风险政府监管措施提供背景参考。方法 笔者通过文献研究与专家咨询法分析生产企业药品上市后风险政府监管效果的影响因素,并对影响因素指标进行分析。结果 从分析统计结果来看,监管相关的法律和法规以及监管结果的发布是监管效果影响的最重要的因素。结论 应进一步完善药品上市后监管的法律法规,对监管结果的公开形式和内容进行科学规划。
Abstract
OBJECTIVE Drug safety regulation is throughout the entire life cycle of drugs . However, the government regulation for the drug post-marketing risk of enterprises have some shortcomings. The research of the impacting factors of government regulation can provide some background reference for the drug post-marketing risk regulation. METHODS In this paper, the influence factors of government regulation for the drug post-marketing risk of enterprises was analyzed by literature research and Delphi method. RESULTS From the analysis results, the regulation related laws and regulations and the outcome of regulation is the most important factor.CONCLUSION It should be further improved the laws and regulations of the drug post-marketing regulations, and the regulation outcome and form should be planned.
关键词
制药企业 /
药品上市后风险 /
政府监管 /
影响因素
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Key words
pharmaceutical enterprise /
drug post-marketing risk /
government regulation /
influence factor
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中图分类号：
R956
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参考文献
[1] FAN D. Thinking of reinforce the adverse drug reaction monitoring for the pharmaceutical.J China Pharm(中国药房), 2012,42(23):3937-3939.[2] WANG G Y, ZHAO H. Roche referred to deceive the deaths of 15000 people report, involved some drug stores in China. J Chin Med Sci (中国医药科学), 2012,82(15):4-6.[3] WU D N. The entity of adverse drug reporting needs to strengthen consciousness. Int Med Health Guidance (国际医药卫生导报),2006,12(03):123-125.[4] ZHAO J, WANG S L. The thinking of adverse drug reaction reporting system in China. Chin J New Drugs(中国新药杂志),2008,17(8):642-644.[5] WANG H X. Study on the adverse drug reactions report system in China. Technology and Business (科技与企业),2013,7(5):228.[6] ZHANG H, DONG D, CHENG G. France and Canada drug regulatory agencies and implication. Chinese Journal of Pharmacovigilance(中国药物警戒) ,2013,10(9):536-538.[7] LI F J, WANG J J,WANG P X, et al. A PEST analysis of general medical education in China and the strategy choice.. Chin Gen Pract(中国全科医学),2013,11(1):69-71.[8] BERDIE D R. Reassessing the value of high response rates to mail surveys. Marketing Research, 1989, 1(9): 52-64.[9] SUN Z Q, XU Y Y. Medical Statistics. Beijing: People′s Medical Publishing House,2002:58-59. TANG J H, CHU X Q. Navy health technology cadres quality comprehensive evaluation index system . J Chin Modern Hospital Management (中华现代医院管理杂志), 2004,2(7):51-53. JING P S. The construction and empirical research for the influence factor index system of Chongqing medical science and technology achievements transformation.The Third Military Medical University(第三军医大学), 2008.
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