FDA通知：2015财年自我识别更新时间（转载0

巴西木

---感谢翻译人：Julia

GDUFA Announcement: FY15 Self-ID Period Update

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)).

GDUFA要求仿制药场所及其它相关场所和组织应向FDA每年进行自我识别信息的更新或确认。2015财年的报告时间段从2014年5月1日开始，2014年6月1日结束。

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.

注意根据联邦食品药品化妆品法案510部分进行的登记和列表与根据GDUFA进行自我识别是不同的程序。许多单位需要分别向不同系统提交信息，每个系统会生成其各自的数据库以符合唯一识别要求及更新期限。当然，两者都是基于相同的平台，基于相同的技术标准。

Additional information including who is required to self-identify, how the information is submitted to FDA, the penalty for failure to self-identify, and the technical specifications are available at the following url:  http://www.fda.gov/gdufa

更多信息，包括谁需要进行自我识别、信息如何提交给FDA、未能进行自我识别的处罚，以及技术标准可以参见以下链接。  

If you need further technical assistant with self-identification process, please contactCDER eFacility@fda.hhs.gov.  For general questions about GDUFA self-identification requirements, please contact AskGDUFA@fda.hhs.gov.

如果你在进行自我识别过程中需要更多的技术支持，请通过CDER邮箱联系。关于GDUFA自我识别要求的一般问题，请通过GDUFA邮箱联系。

Additional resources are available at:更多资源可以访问以下链接

?  [url=http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNDI4LjMxNjc0NDcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDQyOC4zMTY3NDQ3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODIxMTY2JmVtYWlsaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZ1c2VyaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&101&&&http://www.fda.gov/Drugs/Develop ... _source=govdelivery]Technical Walk-Through and Live Question and Answer Session [/url] 11/19/2012 and 11/20/2012

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm327565.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

?  [url=http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNDI4LjMxNjc0NDcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDQyOC4zMTY3NDQ3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODIxMTY2JmVtYWlsaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZ1c2VyaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&102&&&http://fda.yorkcast.com/webcast/ ... _source=govdelivery]Overview and Technical Walk-Through of Self-Identification Process[/url] 9/21/2012

http://fda.yorkcast.com/webcast/Viewer/?peid=5d604f8fb5db4f1b9f0190db50a420611d&playfrom=9242000&source=govdelivery&utm_medium=email&utm_source=govdelivery

Background information is available at [url=http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNDI4LjMxNjc0NDcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDQyOC4zMTY3NDQ3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODIxMTY2JmVtYWlsaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZ1c2VyaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.fda.gov/gdufa?source= ... _source=govdelivery]www.fda.gov/gdufa[/url].  Staff is available at 866-405-5367 or at askGDUFA@fda.hhs.gov  to answer any questions.

相关背景材料可以在官网上找到。电话866-405-5367可通过GDUFA邮箱可以咨询问题。

Interested parties can register to receive email updates about GDUFA at[url=http://links.govdelivery.com/track?

type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNDI4LjMxNjc0NDcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDQyOC4zMTY3NDQ3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODIxMTY2JmVtYWlsaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZ1c2VyaWQ9emh1eXVqaWFvMTk3MkBob3RtYWlsLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&103&&&https://public.govdelivery.com/a ... ?topic_id=USFDA_243]https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_243[/url].

有兴趣的可以注册并接收关于GDUFA更新的邮件。

一沙一叶

Julia是何许人也？

syhorchid

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