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本刊讯国务院办公厅日前印发《药品上市许可持有人制度试点方案》(简称《方案》),对开展药品上市许可持有人制度试点工作作出部署。在北京、天津、河北、上海、江苏、浙江、福建、山东、广东、四川等10省(市)开展试点工作。开展药品上市许可持有人制度试点是药品审评审批制度改革的一项重要内容,有利于药品研发机构和科研人员积极创制新药,有利于产业结构调整和资源优化配置,促进专业分工,提高产业集中度,避免重复投资和建设,对于鼓励药品创
In a few days ago, the General Office of the State Council issued the Pilot Scheme on the System of Pharmaceutical License Holders (“Program”), making arrangements for the pilot work on the system of drug listing license holders. Pilot projects were carried out in 10 provinces (cities) such as Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan. To carry out the pilot system of drug listing and licensing system is an important part of the reform of the system of drug examination and approval, which is conducive to drug research and development institutions and researchers actively creating new drugs, is conducive to industrial restructuring and optimal allocation of resources, and promote professional division of labor and improve industry Concentration, to avoid duplication of investment and construction, to encourage drug innovation