FDA药物审评思路调整与中国研发新思维.pdf

3D Medicines Diagnostics Drug Development FDA药物审评思路调整与中国研发新思维 龚兆龙 博士 思路迪医药科技公司CEO 泰州 2015年10月28 日 美国FDA快速审批 美国FDA新药审批时间不断缩短 FDA NDA批准率高 FDA NDA首轮批准率高 美国全球首先批准上市比例升高 美国FDA特殊加快审评通道 A draft Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics was published on June 25, 2013 美国FDA特殊加快审评通道 ……intended to make therapeutically important drugs available at an earlier time. They do not compromise the standards for the safety and effectiveness of the drugs that become available through this process. • Fast Track 快速通道 • Breakthrough Therapy 突破性治疗 • Accelerated Approval 加快审批 • Priority Review 优先审评 美国FDA特殊审评通道 Fast Track 快速通道 Features: • More frequent meetings • More frequent written correspondence • Eligibility for Accelerated Approval and Priority Review • Rolling Review Qualifying criteria: • A drug that is intended to treat a serious condition AND nonclinical or clinical data demonstrate the potential to address unmet medical need OR • A drug that has been designated as a qualified infectious disease product When to submit: • With IND or after • Ideally, no later than the pre-BLA or pre-NDA meeting 美国FDA 特殊审评通道 Breakthrough Therapy 突破性治疗 Features: • More frequent meetings • More frequent written correspondence • Eligibility for Accelerated Approval and Priority Review • Rolling Review • Intensive guidance on efficient drug development during IND, beginning as early as Phase 1 • Organizational commitment involving senior managers Qualifying criteria: • A drug that is intended to treat a serious condition AND preliminary cli