药品上市许可持有人制度试点对上海生物医药产业的影响分析

Analysis of the impact of MAH on the biomedical industry in Shanghai

通过分析国内外药品上市许可人制度,结合上海生物医药创新所处的环境,通过查询行业数据统计和分析,研究在上海开展药品上市许可人制度试点的可行性和必要性,同时分析这项制度的执行将对上海生物医药产业未来格局产生影响。

The feasibility and necessity of the pilot of drug marketing authorization holder （MAH） system developed in Shanghai were studied by analysis of domestic and foreign drug MAH system and the atmosphere of bio-medical innovation in Shanghai and by literature query and the statistical analysis of industrial data. Meanwhile, the effects of the implement of this system in Shanghai on the future pattern of the biomedical industry of Shanghai were also analyzed.