我国仿制药生产企业WHO药品预认证成熟度评估工具的建立及实证研究

发布时间：2018-05-09 02:39

本文选题：WHO药品预认证(WHO + PQ)　；参考：《中国新药杂志》2015年19期

【摘要】：目的:对我国仿制药生产企业达到WHO药品预认证(prequalification,PQ)标准的能力进行综合评测,识别影响因素,推动企业达到WHO PQ标准,提升仿制药质量。方法:采用德尔菲法,构建仿制药品生产企业WHO PQ成熟度评价指标体系;采用层次分析法,确定各项指标权重;采用线性加权综合法,整合指标打分与指标权重,建立WHO PQ成熟度定量评估工具;选择接受WHO技术支持的国内4家药品生产企业作为样本,测评静态和动态成熟度。结果:4家样本企业的WHO PQ成熟度指数测评,一方面展示了成熟度水平及变化,另一方面识别了仿制药生产企业达到WHO PQ标准的共性技术影响因素(如风险管理、方法验证、药品质量文档和生物等效试验等)和共性非技术影响因素(如企业内部决策效率、部门之间沟通机制、市场盈利分析、外部政策等)。结论:仿制药WHO PQ成熟度测评识别了企业达到WHO PQ标准的影响因素,为我国仿制药生产企业和其他相关方提供有针对性指导,为合力提升仿制药质量奠定基础。
[Abstract]:Objective: to evaluate comprehensively the ability of Chinese generic drug manufacturing enterprises to meet the WHO drug pre-qualification standard, identify the influencing factors, promote the enterprises to meet the WHO PQ standard and improve the quality of generic drugs. Methods: the WHO PQ maturity evaluation index system was constructed by Delphi method, the weight of each index was determined by analytic hierarchy process (AHP), the index score and index weight were integrated by linear weighted synthesis method. A quantitative WHO PQ maturity assessment tool was established, and four domestic drug manufacturing enterprises supported by WHO technology were selected as samples to evaluate the static and dynamic maturity. Results the WHO PQ maturity index of four sample enterprises showed the maturity level and change on the one hand, on the other hand, it identified the common technical factors (such as risk management, method verification) that the generic drug manufacturing enterprises reached the WHO PQ standard. Drug quality documents and bioequivalence tests) and common non-technical factors (such as internal decision-making efficiency, communication mechanism between departments, market profit analysis, external policies, etc.). Conclusion: the WHO PQ maturity assessment of generic drugs identifies the influencing factors of enterprises meeting the WHO PQ standard, and provides targeted guidance for Chinese generic drug manufacturers and other related parties, and lays a foundation for improving the quality of generic drugs.
【作者单位】：沈阳药科大学;中国食品药品检定研究院;
【基金】：Bill and Melinda Gates Foundation资助项目(Global Health Grant Number OPPGH5258)
【分类号】：F426.72

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