摘要
药品委托生产的行为是国内医药企业普遍存在的现象,在企业加快自身资源配置、社会分工细化、降低企业运营成本等方面发挥着重要作用,但是这样不可避免地将药品整个生命周期分散,造成药品研发、生产等环节更加复杂,各个环节主体沟通更加困难,致使产生的危险也会越高。本研究旨在介绍我国境内医药企业之间的药品委托生产,从普通生产企业之间和药品上市许可持有人(MAH)与普通生产企业之间的药品委托生产两个角度出发,分析关于药品委托生产相关法律法规,指出不同情况下的药品委托生产风险。借鉴欧美、日本发达国家先进经验,完善我国关于药品委托生产的法律法规。
The behavior of entrusted production of drugs is a common phenomenon in domestic pharmaceutical enterprises.It plays an important role in accelerating the allocation of resources,refining social division of labor,and reducing the operating costs of enterprises etc.However,the greater the earnings are,the higher the risk is.The purpose of this paper is to introduce the entrusted production of pharmaceuticals between pharmaceutical enterprises in China.From the perspectives of common production enterprises and the entrusted production of medicines between MAH and production enterprises,this paper analyzes the laws and regulations concerning the entrusted production of medicines and points out the the risks of entrusted production under different circumstances.Drawing on the advanced experience of developed countries in Europe,America and Japan,China’s laws and regulations on the entrusted production of drugs are improved.
作者
邢冰冰
梁毅
XIGN Bing-Bing;LIANG Yi(China Pharmaceutical University,Nanjing 211198,China)
出处
《中国药物经济学》
2020年第11期19-24,共6页
China Journal of Pharmaceutical Economics
关键词
药品
境内委托生产
普通生产企业
非生产企业型
药品上市许可持有人
Drugs
Domestic entrusted production
Ordinary production enterprises
Non-production enterprise type
Marketing authorization holder
