关于美国FDA的ANDA申报排队问题
注册申报

请问美国FDA针对Paragraph 4首日申报的ANDA,是否接收资料后会优于其他产品,优先审评

美国ANDA申报的不同品种是否也是像中国一样,按照申报时间先后一起参与排队,并按排队顺序进行技术审评?谢谢!

2014-11-11 11:26 识林-梧桐     
1个回答

(1) In the old system individual CMC reviewers review queue contained a mixture of original ANDAs and Supplements and of some Annual reports. Expedited reviews were placed at the "head of the queue" meaning that the reviewer pick up the expedited application (or supplement) as soon as they were finished with the current review job.
Assuming it is "received for filing" it is then placed into the appropriate reviewer's queue as the next job to be done.  In real timelines that might mean getting an acceptance review within 2 or 3 months instead of 8 or 9 months and getting a first review within say 9 to 12 months (total time since filing) instead of 15 to, well I have one that is now 42 months old and is still waiting for a first review, so who knows?
以往,CMC审评员待处理的任务队列中既有原始ANDA申请,也有一些补充申请年报。优先审评,即“排在队首”,表示审评员将在结束现行的审评任务后,即着手有优先权的申请(或补充申请)。假设“接受、立卷”后,申请立刻进入审评员的任务队列,成为下一个将被处理的任务。意味着将在2到3个月而不是8到9个月的时间内开始审评,即应在9到12个月而不是15个月或更长的时间内完成首轮审评。然而,这里也有历时42个月仍等待首轮审评的申请个例,不能一概而论。
 
(2) How all of this will work under the new OPQ and multiple project managers, I have no idea. The last we heard, CMC reviewers were organized into groups that are assigned all drugs of a particular therapeutic category like Cardiovascular drugs or Analgesics. 
在新的OPQ办公室下项目管理者的工作方式有待观察。最近的消息是,所有药品均按造治疗域,分配给CMC审评员小组,如癌症用药组、镇痛用药组。
 
(3) Specifically for first-to-file para IVs that get sued, the law requires that they get approval (or tentative approval if they also have a para III certification) within 30 months of filing.  If they don't, they risk losing their 180 days of exclusivity.  GPhA claims that "at least 19 first-to-file applicants have forfeited 180 day exclusivity since October 1, 2012".  I know of forfeitures prior to that due to slow OGD review, like taking 26 months to do a first review and then asking for new batches and biostudies.Note that FDASIA extended the 30 months to 40 months to help avoid these forfeitures, but they are obviously still a major and inexcusable problem.
对于含段IV申明的首日申报,规定要求必须在立卷的30个月内获得批准(或者,在同时也含段III申明时,获得暂时批准)。否则申请者将有可能丧失其180天专营期。仿制药生产商协会(GPhA)称,“自2012年10月1日以来,至少有19份首日申报申请者已丧失其180天专营期”。有的情况可能是OGD审评缓慢,如在花费26个月完成首轮审评后再要求新的批次或生物等效性研究所致。现在FDASIA法案将此期限由30个月延长至40个月,以避免此类事件发生,但这一问题仍值得重视。
 
识林-Pepper
 
2014-11-13 16:40 识林-讨论