"优先审评"对应"priority review" "主要针对能够在治疗、诊断或预防疾病上比已上市药品有显著改进的药品上市申请。能够纳入优先审评的并不要求是一个具有全新分子实体的创新药，但必须是在临床疗效上优于已上市产品的药物。优先审评的审评时间为6个月，大约是标准审评时间11个月的一半。与中国鼓励政策不完全相同的是，并不是所有的新分子实体都能进入这个通道，也有一些非新分子实体的新药可以进入该通道（如增加新适应症、改变剂型等）" "优先审评的特点是需要提交完整的新药审评资料，和一般审评适用相同的审评标准，但是FDA 通过增加人力物力的投入，提高此类药品审评的速度。" "1992年，美国通过Prescription Drug User Fee Act，要求药厂付费，以增聘FDA审查员，加速审查时间，并改善一些程序。以往FDA为方便管理，将IND分成下列五类：(A)有重要疗效；(B)有适度疗效；(C)些许或没有疗效；(AA)指定给AIDS；(V)孤儿药；但自1992年以后，仅用两个代码来表示药物审查的优先性：S(Standard review)：与目前流通的药物相似的标准审查；P(Priority review)：比现有药物有重大进展的药物。也因有此法案，让美国审核时间从1987年的33个月缩短至19个月。" Priority Review Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug UserAct (PDUFA), FDA agreed to specific goals for improving the drug review timeand created a two-tiered system of review times – StandardReviewandPriority Review. Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a goal that a Standard Review of a new drug application be accomplished within a ten-month timeframe. A Priority Review designation is given to drugs that offer majoradvances in treatment, or provide a treatment where no adequate therapyexists. A Priority Review means that the time it takes FDA toreview a new drug application is reduced. The goal for completing a Priority Review is six months. Priority Review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. The FDA goal for reviewing a drug with Priority Review status is six months. The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment. Such advances can be demonstrated by, for example: •evidence of increased effectiveness in treatment, prevention, or diagnosis of disease; •elimination or substantial reduction of a treatment-limiting drug reaction; •documented enhancement of patient willingness or ability to take the drug according to the required schedule and dose; or •evidence of safety and effectiveness in a new subpopulation, such as children. A request for Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority orStandardReview designation will be assigned. Designation of a drug as“Priority” does not alter the scientific/medical standard for approval or thequality of evidence necessary."