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

An empirical study on the influence factors of cooperative relationship in entrusted production by marketing authorization holders

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。

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.