北京市开展仿制药一致性评价的实践及进展  

Measures and Progress of Consistency Evaluation of Generic Drug Quality and Efficacy in Beijing

作　　者：冯昊[1,2] 潘悦[2] 雷霆[2] 黄可[2] 

机构地区：[1]军事医学科学院,北京100850 [2]北京生物技术和新医药产业促进中心,北京100193

出　　处：《中国医药工业杂志》2017年第12期1807-1817,共11页Chinese Journal of Pharmaceuticals

摘　　要：2016年3月国务院发布《关于开展仿制药质量和疗效一致性评价的意见的公告》,国家食品药品监督管理总局(CFDA)陆续出台政策指导推动一致性评价工作加快开展。北京市为推动相关政策有效落实,科技部门和监管部门形成合力,出台了一系列政策措施,并设立专项资金,从加快重要品种开展一致性评价工作、建设关键技术平台等方面入手,抓住机遇推动北京生物医药产业创新发展。北京市的相关做法值得借鉴。In March 2016, the State Department issued a notice on ＂Consistency evaluation of generic drug quality and efficacy＂. Then the China Food and Drug Administration （CFDA） has implemented a series of measures. Based on the situation, Beijing city government has organized the science and technology department and the supervision departments together, and established a special government fund to speed up enterprises promote related works and construct key technology platforms. Beijing government’s practices are worth learning.

关 键 词：仿制药一致性评价 科技创新 医药产业 政策 

分 类 号：R95[医药卫生—药学]