对FDA关于ANDA递交时稳定性数据要求的疑问

莫末小鱼

各位，在2014年FDA发布的Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products-Questions and Answers 里面的
Q3(i): Can an ANDA be submitted with 6 months of accelerated stability and 6 months of long-term stability data?A3(i): Yes. An ANDA applicant should submit 6 months of accelerated stability data and 6 months of long-term stability data at the time of submission.
However, if 6 months of accelerated data show a significant change5 or failure of any attribute, the applicant should also submit 6 months of intermediate data at the time of submission.

说在递交ANDA申请文件DMF时应递交6个月的加速和长期稳定性数据吧；而

Q1(i): How many months of long-term and accelerated data are required when a“Completeness Assessment” is performed on the DMF? Also, what should the DMF stability section contain for a Completeness Assessment?
A1(i): To pass the Completeness Assessment, DMFs should include the stability protocol, commitments, and data demonstrating that stability studies have
started. The initial and one additional time point for the accelerated studies and long-term studies are sufficient. If the DMF does not meet the recommendations under A1(ii) below at the time of the Completeness Assessment the DMF holder should amend the DMF with updated stability data to prepare for full scientific review.

这里是不是说在完整性评估时只要初始和多1个时间点（是不是指0个月和3个月）的加速和长期稳定性数据就可以了呢？如果是的话，是不是说在递交DMF时只提供3个月的稳定性数据也是可以的呀？那这是不是与上面的说法矛盾了呢？


请大侠帮忙解疑，或者是不是我理解错误了呢？

三尺之冰

不了解，但是我们的都是提交6个月的加速和长期稳定性数据的，没其他情况

jiang376

咨询公司公司给我们讲可以提供前三个月的数据

yan1302

前面说的是制剂ANDA，后面说的是原料药DMF

莫末小鱼

yan1302 发表于 2015-3-7 20:58
前面说的是制剂ANDA，后面说的是原料药DMF

原料药厂家的API的DMF不属于ANDA么？

beiwei5du

莫末小鱼 发表于 2015-3-9 09:27
原料药厂家的API的DMF不属于ANDA么？

Abbreviated New Drug Application (ANDA)
An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

ANDA和DMF的程序不同，ANDA提交时需要至少6个月的long term和accelerated stability datas。同时DMF时需要进行Completeness assessment和scientific review阶段，在第一个阶段是仅仅需要（To pass the Completeness Assessment, DMFs should include the stability protocol, commitments, and data demonstrating that stability studies havestarted. The initial and one additional time point for the accelerated studies and long-term studies are sufficient），在第二个阶段则是需要至少6个月的long term和accelerated stability datas

godman

我单位就1个月的加速数据就提交了。也可以的