仿制药API设施自我鉴定法案最新消息

wuguyi99

迄今为止，超过1700个API设施已经自我鉴定, 但仍然有很多尚未注册. 我想许多中国API公司并不知道这条仿制药API设施自我鉴定法案. FDA延长注册期限直2012年12月18号.


FDA公告如下:

The FY 2013 reporting period for facility self-identification closed on December 3, 2012.  Under the statute, generic drug products manufactured in facilities that have not self-identified, or including active ingredients manufactured in facilities that have not self-identified, are misbranded.  FDA is announcing, however, that there will be a two-week grace period, until December 18, 2012, in which facilities that have not yet successfully completed the self-identification process may do so without penalty.

The Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III) requires the identification of facilities involved in the manufacture of human generic drugs and associated active pharmaceutical ingredients. Self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay annual facility user fees. Second, self-identification is a central component of an effort to promote global supply chain transparency and facilitate inspections and compliance.

To date, more than 1,700 facilities have self-identified for FY 2013. This figure is below estimates of the universe of generic drug facilities. Similarly, an analysis of facilities identified in Abbreviated New Drug Applications and Prior Approval Supplements submitted since October 1, 2012 suggests that not all facilities are self-identifying. One out of eight facilities in these recent submissions has failed to self-identify, a trend that, if uncorrected, will result in higher individual facility fee amounts.

The two week grace period should enable facilities who have not yet registered to do so.  FDA does not want to penalize companies that have already complied with this new requirement by setting higher annual facility fee rates based on an artificially low industry reporting base.