FDA对药品生产商的新规

GMP News
20/09/2016

FDA?s New Regulations for Drug Manufacturers

FDA对药品生产商的新规

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.

美国FDA修订了其对国外和本土人药工厂注册和列表的要求，包括受生物制品许可申报和兽药法规约束的药物。

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.

最终规定修订了FDA长期未修改的药品生产工厂注册和药品列表法规。修订案目的是更新法规，提高FDA和药品生产商的效率和可靠性。

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).

修订后的法规最终版本共有200多页，将于联邦公报上公布（计划2016年8月31日）后90天生效。

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.

截止目前，药品生产商都需要每年向FDA注册其工厂。其中，药品生产场所注册会识别出FDA所需检查的工厂。另外，每个登记过的工厂还需要提交一份其所生产的药品清单。修订案对这些规定进行了更新，使其符合最近修订过的FDCA。

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."

FDA说“修订案重新组织、修改并澄清了目前的法规关注点，包括谁必须注册工厂和列出人药清单、生物制品类人药，同时也是兽药的人药清单。除特定的豁免情形外，新规要求电子申报登记和列表信息。制订此规定适用于制剂、原料药以及含有其它成分的原料药。新规描述了生产或加工药品的工厂所有者和运营者必须在何时以何种方式向FDA登记其工厂，列出其所生产或加工的药品。”

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.

总而言之，新规要求除特定豁免情形外，药品生产工厂要以电子方式申报登记和列表信息。电子申报要求是与FDAAA和当前做法相一致的。因此，新规澄清并完善了FDA的电子注册和列表系统的现代化。

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 specify that registrants must review and update registration information between 1 October and 31 December each year.

工厂注册和列表是生产、重新包装、重新标签或回收利用药品人的义务。此规定并不要求私人标签分销商注册工厂或列表药品，而是允许他们代表生产、重新包装、重新标签或回收利用药品的人员，作为其代理提交药品列表信息。修订后的法规也是为了说明注册者必须在每年10月1日至12月31日之间审核和更新注册信息。

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.

修订后对药品工厂信息注册，以及列出其所生产、重新包装、重新标签或回收利用药品的信息提交时间和物质做了几个调整。另外，监管FDA药品注册和列表信息公开化管理条款中，声称除特定的例外情况外，工厂通常可必须获得药品注册和药品。

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.

更多信息参见官网。

来源：Julia