美国FDA加快新药审评策略以及对我国的启示

US FDA new drug expedited review strategies and its implications for China

借鉴FDA新药审批的理念、策略和方法,在保证中国药品的安全有效和质量可控的基础上,推动创新性新药的加快审批。本文通过分析美国新药审评基本理念,美国、欧洲以及日本新药审批速度,美国FDA快速通道、突破性疗法、加速批准和优先审评等4种途径的差异点,对我国建立和完善加快新药审评制度提出5条建议。

Ensuring the safety,efficacy and quality of drugs is not the single responsibility of drug regulatory authorities,promoting public health and ensuring the availabilities of innovative new drugs to patients are also their compelling obligations. By analyzing the basic philosophy of US new drug review practices,the new drug review speeds of US,Europe and Japan,and the similarities and differences of four review routes of US FDA,i. e. fast track designation,breakthrough therapy designation,accelerated approval,and priority review designation,this paper proposes five suggestions for the establishment and improvement of Chinese new drug expedited review system.