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

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.