首页 > 资讯 > FDA发布仿制药场地自我认定指南

出自识林

2016-09-23 Lachman CONSULTANTS

美国FDA于9月22日发布《仿制药设施、场地和机构的自我认定》定稿指南。根据2012仿制药使用者付费修正案（GDUFA），所有仿制药设施、场地和机构必须遵循GDUFA的自我认定要求。该指南文件旨在帮助企业理解自我认定要求，从而使得自我认定更容易实现。文件还讨论了哪些设施、场地和/或机构需要支付GDUFA费用。

指南讨论了：

• 哪类仿制药设施、场地和机构需要自我认定；
• 需要什么信息；
• 用于电子提交所要求信息的技术标准是什么；
• 未能自我认定的处罚。

建立自我认定过程是为了实现以下两个目标：

• 确定付费设施的数量；
• 建立一份所有场地和设施的清单以提升供应链的透明度并提供可能需要检查的场地和设施的准确清单。

该指南文件提供了简洁的描述、认定流程，并概述了在自我认定体系中必须遵循的要求。该指南也提醒我们如果企业未能自我认定，那么与该设施相关的任何产品被认为是错标冒牌的，从而会立即受到执法行动。另外，请记住，这不是一次性的过程，必须每年完成。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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Self-Identification Guidance for Generic Facilities Issued by FDA
By Bob Pollock | September 22, 2016 原文地址

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, all generic facilities, sites and organizations are required to comply with the self-identification requirements of the GDUFA. This Guidance document is intended to facilitate firms’ understanding of the requirements, and thus, make self-identification easier to accomplish. The document also discusses which of the facilities, sites, and or organizations will have to pay a GDUFA user fee.

The Guidance discusses:

• which types of generic facilities, sites, and organizations are required to self-identify;
• what information is requested;
• what technical standards are to be used for electronically submitting the requested information; and
• the penalty for failing to self-identify.

The self-identification process was established to accomplish two goals:

• determine the number of fee paying establishments and
• develop a list of all sites and establishments to promote supply chain transparency and provide an accurate listing of sites and facilities that may need inspection.

The Guidance document, which can be found here, provides concise descriptions, identifies processes, and outlines requirements that must be followed in the self-identification scheme. It also reminds us that if a firm fails to self-identify, any product that is associated with that establishment is considered to be misbranded, and thus, subject to immediate enforcement action. Talk about the carrot and the stick! Also remember, this is not a one-time process, and must be completed annually.