我国药品技术转让时机及应对策略分析

发布时间：2018-05-12 06:20

本文选题：药品技术转让 + 药品注册审批　；参考：《中国药房》2017年19期

【摘要】：目的:探讨新药、仿制药与进口药不同技术转让时机的风险、利弊与应对策略,为医药企业发展战略的提升提供依据。方法:根据与药品注册和转让有关的规定,分析新药、仿制药与进口药注册申请过程中可转让的项目,探讨其相应的转让时机及风险,并提出应对策略。结果与结论:药品注册过程中可转让的项目包括知识性产权(专利权、专利申请权、技术秘密、申请资料、未披露数据等)与权力性产权(临床批件、新药证书、药品批准文号、医药产品注册证、进口产品注册证等)。药品技术转让有4个时机,时机1为转让方在完成药理学、毒理学等临床前研究后,申请临床批件前;时机2为转让方取得临床批件后,启动临床试验前;时机3为新药技术转让;时机4为药品生产技术转让。新药有4个转让时机,仿制药与进口药在时机1、2、4可进行转让。不同时机的转让风险与利益各不相同,随着药品注册进程推进,风险逐渐降低,但创新性也随之降低。企业应结合政策、市场和自身特点选择合适的产品和转让时机。
[Abstract]:Objective: to explore the risks, advantages and disadvantages of different technology transfer opportunities, advantages and disadvantages of new drugs, generic drugs and imported drugs, and to provide the basis for the development strategy of pharmaceutical enterprises. Methods: according to the regulations related to the registration and transfer of drugs, the transferable items in the application for registration of new drugs, generic drugs and imported drugs were analyzed, the corresponding transfer opportunities and risks were discussed, and the countermeasures were put forward. Results & conclusion: the transferable items in the process of drug registration include intellectual property right (patent right, patent application right, technical secret, application information, undisclosed data, etc.) and power property right (clinical approval, new drug certificate, etc.) Drug approval number, pharmaceutical product registration certificate, import product registration certificate, etc. There are 4 opportunities for the transfer of drug technology: 1) before the transferee applies for clinical approval after the completion of preclinical studies such as pharmacology and toxicology, 2) before the clinical trial is initiated after the transferee has obtained the clinical approval; Opportunity 3 is new drug technology transfer, opportunity 4 is drug production technology transfer. New drugs have four opportunities to transfer, and generic drugs and imported drugs can be transferred at time 1 / 2. The transfer risk and benefit are different in different time. With the progress of drug registration, the risk is gradually reduced, but the innovation is also reduced. Enterprises should combine policy, market and their own characteristics to choose the right product and transfer time.
【作者单位】：哈尔滨医科大学人文社会科学学院;
【基金】：2014年度黑龙江省社会科学研究规划项目(No.14B017) 2014年度黑龙江省应用技术研究与开发计划项目(No.GC14D410) 四川省医事卫生法治研究中心立项项目(No.YF17-Q07)
【分类号】：R95

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