FDA´s New Regulations for Drug Manufacturers

胜利者

请通晓FDA法规的蒲友解惑

The US Food and Drug Administration (FDA) amends its requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs.

The final rule revises FDA's longstanding regulations governing drug establishment registration and drug listing. The amendments are aimed at modernizing these regulations and improving efficiency and reliability for both - FDA and drug manufacturers.
The more than two hundred pages final rule is expected to come into effect 90 days after publication in the Federal Register (scheduled August 31, 2016).
Up to now drug manufacturers have been required to register their establishments with FDA annually. Among other things, drug establishment registration identifies establishments for inspection by FDA. Furthermore, for each registered establishment it is required to submit a list of drugs it manufactures. The amendments adopted by this final rule modernize those regulations and bring them into conformance with recent amendments of the FD&C Act.
The FDA states that "the amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process."
In summary, the final rule requires electronic submission, unless waived in certain circumstances, of drug establishment registration and listing information. The electronic submission requirement is consistent with FDAAA (Food and Drug Administration Amendments Act) and with current practice. Thus, the final rule clarifies and completes the modernization of FDA´s electronic registration and listing systems.
Establishment registration and listing obligation rests with persons who manufacture, repack, relabel, or salvage drug products. The rule does not require persons who act only as private label distributors of drug products to register establishments or list drugs, but allows them to submit drug listing information as agents acting on behalf of persons who manufacture, repack, relabel, or salvage drug products. Also revised is the statute to specifiy that registrants must review and update registration information between 1 October and 31 December each year.
The revisons make several adjustments to the timing and substance of the submission of information to register a drug establishment and list drugs manufactured, repacked, relabeled, or salvaged at the establishment. Additionally the provisions governing FDA disclosure of drug registration and listing information, stating that with certain exceptions, establishment registration and drug listing information is generally available for public disclosure, have been updated.
For more information please see the final rule Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.

懒虫9527

学习中，慢慢来

阿炳1987

等下，先找个翻译软件，看懂了再说

懒虫9527

FDA修订了对于国内外已注册和上市的人用药品（包括按照生物产品许可申请进行管理的药物和动物药物）的要求。
本规定修正了FDA关于长期药物的注册和上市的规定。本修正案旨在使相关规定符合实际，并提高FDA和药品制造者的效率和可靠性。
两百多页的修改后规定将在联邦公告90天后开始生效（将于2016.08.31）。
目前，FDA已经要求药品生产者每年注册自己的生产机构。除此之外，FDA通过识别药品机构的注册进行检查。此外，还要求每一个注册机构提交一份它自己生产的药物的清单。最终被采用的修正案能使相关规定符合实际，并顺应联邦法案的最新修正案。
FDA指出该修正案重组、修改和澄清了关于人用药物、人用生物制剂和动物药物的机构和清单注册的现有规定。修正后的规定要求除了某些情况，注册和上市信息均需要进行电子提交。该规定适用于最终成品、单一成分和/或多种成分的原料药API。修订后的规定描述了药品生产或加工机构的所有者或经营者如何和何时必须在FDA注册他们的机构并列出生产或加工的药物清单。
总之，修订后规则要求，除了某些情况，注册和上市信息均需要进行电子提交。电子提交的要求应符合FDA修正法案和当前的实践。修订后规则能澄清和补充完整FDA的电子注册和上市系统使之更现代化。
注册和上市机构的义务取决于生产、重新包装、重新贴签或抢救药品的人。规则不要求药品分销商的自有标签进行机构注册或药品列举，但允许他们作为生产、重新包装、重新贴签或抢救药品的人的代理人提交药品清单信息。修订后规则要求注册者必须在每年10月1日至12月31日间审查和更新注册信息。
本修正版对以下信息提交的时限和内容进行了一些调整：药品机构注册和生产、重新包装、重新贴签或抢救药品的机构的药品清单。另外，对药品注册和上市信息的FDA披露的调整、某些例外的说明、机构注册和药品上市信息等公开披露的规定已经更新。
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懒虫9527

使用有道翻译，并调整了语序，感觉有些地方翻译的还是不够准确。
个人水平有限，敬请大家包涵。
期待大家的指正。