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我国药品技术转让时机及应对策略分析
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| 篇名： | 我国药品技术转让时机及应对策略分析 |
| TITLE： | |
| 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 investigate the risk， advantages and disadvantages and countermeasures of new drugs， generic drugs and imported drugs in different transfer opportunities， and to provide basis for improvement of development strategy for pharmaceutical enterprises. METHODS： The analysis was done in accordance with relevant regulations on transferable projects in the process of applying for registrations of new drugs， generic drugs and imported drugs. The transfer period and risk were explored and countermeasures were put forward. RESULTS & CONCLUSIONS： Transferable projects included intellectual property rights （patents， patent application， technical secrets， application information， non-disclosed data， etc.） and ownership rights （clinical trial approvals， new drug certificates， drug approval number， pharmaceutical product registration certificates， imported product registration certificates， etc.） in the process of applying for registrations. There are 4 opportunities for drug technology transfer， opportunity 1 is before applying clinical trial approvals after the completion of non-clinical research such as pharmacology， toxicology； opportunity 2 is ahead of clinical trial after the acquirement of clinical trial approvals； opportunity 3 is new drug technology transfer； opportunity 4 is production technology transfer. The new drugs have 4 transfer opportunities， generic drugs and imported drugs can transfer in opportunity 1， 2， 4. Different transfer opportunities present different risks and profits. The risk gradually decreases with the further promotion of drug registration process， while the innovation decreases at the same time. Pharmaceutical enterprises should combine with the policy， market and their own features to select a suitable transfer period. |
| 期刊： | 2017年第28卷第19期 |
| 作者： | 韩月，刘兰茹，朱虹，邢爽 |
| AUTHORS： | HAN Yue，LIU Lanru，ZHU Hong，XING Shuang |
| 关键字： | 药品技术转让；药品注册审批；药品转让时机；药品转让策略；新药；仿制药；进口药 |
| KEYWORDS： | Drug technology transfer； Drug registration approval； Opportunities for drug transfer； Countermeasures for drug transfer； New drugs； Generic drugs； Imported drugs |
| 阅读数： | 570 次 |
| 本月下载数： | 18 次 |
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