摘 要 新版GMP的实施加速了药品生产企业间药品技术的转让和流通速度，在实现药品技术资源科学配置、行业结构优化调整的同时也存在着不少现实问题，阻碍了药品技术转让规范、高效地开展，给药品质量管理带来了一些隐患，要解决这些问题，应加强现场监管、建立科学的审批机制、改革药品技术转让市场的主体准入机制及建立药品技术转让的市场化流通机制。

    关键词药品技术转让监管对策研究

    中图分类号：R951文献标识码：C文章编号：1006-1533(2014)13-0065-03

    Problem and countermeasure in technology transfer of medicine in China

    QIAO Yu，CHU Shuzhen

    (School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China)

    ABSTRACT The implementation of new GMP has accelerated the frequency and circulation rate of medicine technology transfer among pharmaceutical manufacturers. However, some practical problems still exist with scientific allocation of medicine technology resources and optimization of industry structure, which may hinder the normative and efficient development of medicine technology transfer, and also cause some hidden trouble. To settle these problems, great efforts should be made from several aspects: strengthening on-site supervision, establishing scientific approval mechanism, reforming the access mechanisms of market subjects for medicine technology transfer and constructing market-based circulation mechanism for technology transfer. ......