2014-04-30 Lachman CONSULTANTS

当你以为一切都已经完成时，是时候重做一遍了。FDA公布仿制药申请中新的场地自我认定(Self-Identify)很快将再次开始。FDA公告规定：

《2012年仿制药使用者付费修正案》规定在仿制药申请时鉴定的仿制药厂房设施、某些场地和机构需每年向FDA提交、更新或重新确认认定信息。2015财年的自我认定报告周期将于2014年5月1日开始，2014年6月1日结束。(21 U.S.C. § 379j–42(f)(2)(B))

请注意以下要点：

请注意，根据联邦食品、药品和化妆品法案第510节（21 U.S.C. § 360）的注册和登记是与GDUFA的自我认定不同的过程。因此需要许多人分别提交信息到各自的系统。每个系统需要填充自己的数据库以满足特殊要求和截至日期。但是，两者建立在相同的平台上并基于相同的技术标准。 因此，为了完全弄清楚，再说一次。由于许多设施是非GDUFA付费支付的，需要进行设施及产品的注册和登记。自我认定过程是用于跟踪缴付费用的机构，以及鉴定可能被豁免收费但仍需要根据一般程序进行检查的设施。

似乎是重复的？是的，但是直到FDA计算机系统在某种程度上实现无缝交流，否则企业将需要继续使用FDA提供的现有基础设施和软件填写不同的数据库。祝好运，另外不要忘记，4月15日（美国报税的截止日期）来了又过去，FDA的追税人来了。

编译：识林-椒 2014-04-30

Just when you thought you got it all done, it is time to do it all over again. FDA announced that the new self-identification for facilities named in a generic drug application will begin again soon. The FDA announcement states:

Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, and certain sites and organizations identified in a generic drug submission to submit, update, or reconfirm identification information to the Food and Drug Administration (FDA) annually. For fiscal year 2015 self-identification reporting period will begin on May 1, 2014, and close June 1, 2014. (21 U.S.C. § 379j–42(f)(2)(B)).

And very importantly please note the following:

Please note that registration and listing under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360) is a different process than self-identification under GDUFA. Many persons will thus be required to submit information separately to the respective systems. Each system populates its own database to meet unique requirements and deadlines. Both, however, are built on the same platform and based on the same technical standards.

So to make this perfectly clear, once is not enough. Facility and product listing and registration need to be conducted as many facilities are non-GDUFA fee paying. The self-identification process is used to keep track of the fee paying organizations, as well as identify facilities that may be fee exempt, but may still need to be inspected under the generic program.

Seems like duplication? Yes, it is, but, until the FDA computer systems all speak to each other in a manner that is seamless, the industry will need to continue to populate these various databases using the existing infrastructure and software that FDA makes available. Good luck and, don’t forget, now that April 15 has come and gone, the FDA tax man commeth.