首页 > 资讯 > FDA发布最终规定修订场地注册和药品登记相关法规

出自识林

2016-09-01 Lachman CONSULTANTS

8月31日美国FDA在联邦公报（FR）通告中发布对药品场地注册和药品登记的法规修订，修订后的最终规定将于从发布之日起90天后生效。这份200多页的最终规定旨在使联邦食品、药品和化妆品法案（FDCA）207章和607章的药品登记和场地注册要求现代化，并使其与最近修订的510章一致。

在FR通告的概要中，FDA表示，最终规定

• 要求以电子方式提交药品和场地登记信息（除非获得豁免）
• 明确表示登记和注册是制造、重新包装、重新标签或回收药品之人的责任
• 不需要私有标签分销商登记场地或药品，但允许他们作为制造商代理登记药品。
• 对场地注册和药品登记过程的时间和实质性内容做了一些调整
• 更新对药品登记信息公开披露的长期管理规定

FDA于2006年8月29日发布拟议规定，收到许多评议，根据这些评议，FDA删除了原来在拟议规定中的以下两项条款：

• FDA而不是注册人制定分配给已登记药品的美国国家药物码（NDC）的要求。（FDA不再计划发布这些号码，并将继续执行由申办人分配NDC号码的做法。）
• 在每个已登记药品上以人类可读格式显示NDC号码的要求以及出于这一目的对适当NDC定义的条款。

最终规定提供了药品和场地登记过程的完整历史，是对这些要求及其起源的伟大回顾。规定中还提供了其它监管要求，例如，现在某些章节规定如果生产某一药品（动物或人用）的场地没有注册，除非该场地根据21CFR207部分豁免注册，FDA将拒绝批准该药。最终规定中的表1提供了从拟议规定到最终规定实质性变化的概述，对于突出最终要求以及所属条款非常有帮助。覆盖的一些主题有：

• 术语的定义。
• 哪些主体处于监管范围之内？
• 哪些主体豁免于注册和登记要求？
• 哪些主体必须注册？
• 注册所需信息有哪些？
• 注册的时间要求是什么？
• NDC号码是什么，是如何分配的？
• 需要分配新NDC号码的变更有哪些？
• 哪些主体必须登记药品，哪些药品必须登记？
• 如何登记血液制品？

以上只是最终规定覆盖的一小部分问题。未来我们将尝试讨论一些重要的主题。强烈建议企业仔细阅读该最终规定，如果需要的话，应在建立与该法规要求一致的政策和流程方面寻求帮助。

Lachman CONSULTANTS - Bob Pollock先生
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202 Page FR Notice – Final Rule for Revised Drug Listing and Manufacturers Registration, Take Note! By Bob Pollock | August 30, 2016 原文地址

Have some spare time on your hands? Read the new Final Rule that FDA pre-published today (here) . FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in conformance with section 510 of the Federal Food, Drug and Cosmetic Act (FFDCA), as recently amended.

In the summary of the FR notice, the Agency says the rule:

• Requires electronic submission of drug and establishment listing information (unless a waiver is obtained)
• Makes clear that the responsibility for listing and registration lies with the persons who manufacture, repack, relabel, or salvage drug products
• Does not require private label distributors to list establishments or drug list, but permits them to drug list as an agent of the manufacturer.
• Makes certain adjustments to the timing and substance of the process
• Updates longstanding governing public disclosure of drug listing information

The rule received many comments, and based on those comments, FDA removed the following two provisions that were in the proposed rule:

• FDA had proposed to issue the NDC numbers, rather than the applicant assignment the number. FDA no longer proposed to issue the numbers and will continue the practice of NDC number assignment by the sponsor
• FDA removed the requirement that the NDC number appear in human readable form on each listed drug and removed the provision that would have defined the appropriate NDC for that purpose.

The Final Rule provides a complete history of the drug and establishment listing process and is a great review of the requirements and their genesis.

Additional regulatory requirements are provided in the rule, for instance, certain sections now provide that FDA will refuse to approve a drug product (animal or human) if the establishment it is produced in is not registered, unless that establishment is exempt from registration under part 207. Table 1 in the Final Rule provides an overview of the changes from the Proposed Rule and is useful in highlighting the final requirements and where they can be found. Some of the topics covered are:

• Definitions of terms
• Who is covered under the regulation?
• Who is exempt from registration and listing requirement?
• Who must register?
• What information is required for registration?
• What are the timing requirements for registration?
• What is the *NDC number and how is it assigned?
• What changes require the assignment of a new NDC number?
• Who must list drugs and which drugs they must list?
• How to list blood products

These are just a few of the issues covered in the final rule. We will try to cover some of the more important topics in future posts. It is highly recommended that firms review this final rule carefully and obtain assistance, if necessary, in establishing a policy and process that will be consistent with its requirements. The 90-day clock will begin tomorrow!