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。
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.
出处
《上海医药》
CAS
2014年第13期65-66,80,共3页
Shanghai Medical & Pharmaceutical Journal
关键词
药品
技术转让
监管
对策研究
medicines
technology transfer
supervision
countermeasure research
