首页|药品上市许可持有人委托生产合作关系影响因素的实证研究

药品上市许可持有人委托生产合作关系影响因素的实证研究

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在药品上市许可持有人委托生产过程中,提升合作双方的合作关系有利于提高合作的服务质量,解决药品委托生产中的问题,促进药品上市许可持有人制度顺利开展.通过分析合作关系和药品上市许可持有人委托生产特征,提炼出影响双方合作关系的3 个主要影响因素,包括受托生产企业基础条件、资源互补和互动水平.构建3 个因素对药品上市许可持有人与受托生产企业合作关系的影响因素模型,并提出相关假设,以问卷调查的方式对研究模型和假设进行检验.结果表明3 个因素均对药品上市许可持有人委托生产合作关系有显著正向影响,假设均得到验证,其中互动水平对合作关系的影响程度最高,资源互补次之,受托生产企业基础条件最低.建议药品上市许可持有人提升合作交流水平、均衡资源依赖、加强对受托生产企业基础条件评估,从而加强委托生产中双方的合作关系.
An empirical study on the influence factors of cooperative relationship in entrusted production by marketing authorization holders
In the process of entrusted production by marketing authorization holders,enhancing the cooperative relationship between the two parties is conducive to improving the service quality of cooperation,solving the problems in entrusted production of drugs,and promoting the smooth development of the marketing authorization holders system.By analyzing the characteristics of the cooperative relationship and the entrusted production by marketing authorization holders,three main factors affecting the cooperative relationship were extracted,including the basic conditions of the entrusted production enterprises,resource complementarity and interaction level.A model of the three factors influencing the cooperative relationship between the marketing authorization holders and the entrusted production enterprise was constructed,and relevant hypothesis was put forward.The research model and hypothesis were tested by questionnaire survey.The results showed that the three factors had a significant positive impact on the cooperation relationship of marketing authorization holders entrusted production,and the hypotheses were verified,among which the interaction level had the highest impact on the cooperation relationship,followed by the resource complementarity,and the basic conditions of the entrusted production enterprises had the lowest impact.It is suggested that marketing authorization holders enhance the level of cooperation and exchange,balance resource dependence,and strengthen the evaluation of the basic conditions of the entrusted production enterprises,so as to improve the cooperative relationship between the two parties in the entrusted production.

marketing authorization holderentrusted production enterprisescooperative relationshipinfluence factors

王雪雅、潘枭颖、茅宁莹

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中国药科大学国际医药商学院,南京 211198

药品上市许可持有人 受托生产企业 合作关系 影响因素

江苏省科技厅软科学研究计划江苏省社会科学基金一般项目江苏省精品工程项目

BR202206822JZB00222SYB-036

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(16)