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为解决药品注册申请积压问题,提高药品审评审批质量和效率,国家食品药品监管总局2015年11月12日发布《关于药品注册审评审批若干政策的公告》,并于当日起实施。食药监总局药化注册司副司长李茂忠介绍,公告对提高仿制药审批标准、优化临床试验申请的审评审批、实行同品种集中审评、严格审查药品的安全性和有效性、加快临床急需等药品的审批、严惩临床试验数
In order to solve the backlog of drug registration applications and improve the quality and efficiency of drug examination and approval, the State Food and Drug Administration released the Notice on Certain Policies for Examination and Approval of Drug Registration Reviews on November 12, 2015, which was implemented on the same day. Pharmaceutical Administration of Drug Registration Li Maizhong, deputy director introduced the notice to improve generic drug approval standards, to optimize clinical trial application review and approval, implementation of the same type of centralized review, strict review of the safety and effectiveness of drugs, to speed up clinical Urgent need for approval of drugs, severely punished clinical trials