药品技术转让中“控股转让”规定的研究

Study on the regulation of "holding transfer" in technology transfer of drugs

目的:对《药品技术转让注册管理规定》中"控股转让"相关条款进行分析,期望为政策制定者修订药品技术转让方面规定提供理论依据,以增加其适用性。方法:通过对药品技术转让中"控股转让"规定的合法性、合理性、必要性进行细致探讨,对该规定法理缺陷进行深入分析。结果与结论:"控股转让"规定合法性、合理性、必要性有待完善,因此建议有关部门予以调整。

Objective： This paper mainly analyzes the regulation of holding transfer in ＂Administrative regulations for technology transfer registration of drugs＂, expecting to provide the theoretical basis for the policymakers to revise drug technology transfer regulations, which could increase its applicability. Method： The legal defects of the provision were analyzed by discussing its legitimacy, rationality, necessity. Result Conclusion： The legitimacy, rationality, necessity of regulation of ＂Holding transfer＂ need to be perfect. It is proposed that the relevant departments can revise the regulation.