美国FEI number申请的那些事儿

偶尔范范小糊涂

说道FEI，表示做过美国注册的小伙伴是不会陌生的。

一开始有可能大家就比较容易混淆就是这个FEI是Facility Establishment Identifier 还是FDA Establishment Identifier？

其实都一样哈。

下面就申请做简要说明：

FDA Establishment Identifier 的申请比较简单

根据FDA 问答Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidance for Industry
https://www.fda.gov/media/131911/download
申请FEI号码: 需要向 FDAGDUFAFEIRequest@fda.hhs.gov 发邮件：
(a) Subject: Foreign or Domestic FEI request for (firm name)
(b) Company Legal Name for the location for which the activity is being conducted
(c) Company Address for the location for which the activity is being conducted
(d) Company Point of Contact (name, email, telephone number)
(e) Activities the firm is going to participate in regarding the drug product
(manufacturing, labeling, testing, etc.)
(f) Known drug products (API, finished dose, intermediary)
(g) Registered with FDA (if so, include the registration number)



以及FDA指南：Self-Identification of Generic Drug Facilities, Sites, and Organizations Guidance for Industry
Facilities must also submit a Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms. 7
A business entity that has previously obtained an FEI number may verify its FEI number by sending an email request to FDAGDUFAFEIRequest@fda.hhs.gov.
Alternatively, business entities that have not previously registered with FDA can obtain an FEI number by sending an email request to FDAGDUFAFEIRequest@fda.hhs.gov. Please type “GDUFA FEI Request” in the subject line and include the following information in the body of the email:
Firm Name
Facility Address including City, Province, Country, and Mail Code
Size of Firm
Type of Operation (Manufacturer, Lab, etc.)
Type of Industry: Drugs
Requests for issuance of FEI numbers associated with GDUFA self-identification are typically processed within 10 to 15 business days.

cindychujiajia

可以再分享多一些

偶尔范范小糊涂

发完邮件后，根据收到Office of Pharmaceutical Quality Operations回复的邮件：

Thank you for the information. Before you may receive an FEI number, you are required to register the facility.

Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S.

Instructions to register:

• Create an account in CDER Direct and complete the “Establishment Annual Registration” submission
• To view a step-by-step tutorial on how to complete Establishment Registration,
• Upon registration, you will receive an email from CDER Direct indicating that an account has been created; this is only a confirmation of an account. You will need to log in and complete the submission.
• You can complete this submission withoutan FEI number; simply leave this field blank.
• Once your submission reads “submission accepted”,  please proceed with listing the drug products the facility intends to import for U.S. commercial distribution via your CDER Direct account. Please continue to list the products within your CDER Direct account even if you have already listed the products on another agency website.
• Once you have completed drug product listing, please revert and we will provide an FEI number.
  

需要进行Establishment registration和 Drug product listing(s)，之后再分配一个FEI number.
参见这个网页：
https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions

原酒言

楼主九敏啊！！！！
求问做了一个新FEI号的申请，开始给FDAGDUFAFEIRequest@fda.hhs.gov 发邮件，但是一个月都没有收到回复，之后申请了 CDER Direct 的账户，进行了
Establishment Registration，但是后面就不知道该怎么办了，没有其他选项了，也没有一个页面是可以空着FEI号的，求救后面该怎么办呀！！！！

补充内容 (2023-2-10 11:07):
好的已经申请到啦！

五和养生堂

原酒言 发表于 2023-2-6 11:56
楼主九敏啊！！！！
求问做了一个新FEI号的申请，开始给 发邮件，但是一个月都没有收到回复，之后申请了 C ...

你好，想咨询一下，FEI申请只做Establishment Registration可以吗？还必须要进行Drug product listing才可以获得FEI号吗？

五和养生堂

偶尔范范小糊涂 发表于 2022-3-15 11:55
发完邮件后，根据收到Office of Pharmaceutical Quality Operations回复的邮件：
Thank you for the infor ...

是必须要做Drug product listing吗？仅做Establishment registration申请不到FEI号吗？

偶尔范范小糊涂

五和养生堂 发表于 2023-11-30 08:29
是必须要做Drug product listing吗？仅做Establishment registration申请不到FEI号吗？

申请不到申请不到

五和养生堂

偶尔范范小糊涂 发表于 2023-12-1 13:08
申请不到申请不到

可以加你个联系方式吗？我的邮箱 jennieyang88@163.com

原酒言

五和养生堂 发表于 2023-11-23 08:44
你好，想咨询一下，FEI申请只做Establishment Registration可以吗？还必须要进行Drug product listing才 ...

抱歉才看见，不知道你弄完了没有。
不用做产品列名，它是那个啥，创立CDERdirect账户的时候现在要选Establishment Registration and drug listing，但是进入账户里面后，不用管第二个，只管第一个Establishment Registration就行了，这里有个FDA的教程，照着做就可以https://direct.fda.gov/apex/f?p=100:103:128271917144396::NO:103_GUIDE:5

原酒言

原酒言 发表于 2024-1-12 17:14
抱歉才看见，不知道你弄完了没有。
不用做产品列名，它是那个啥，创立CDERdirect账户的时候现在要选Esta ...

https://direct.fda.gov/apex/f?p=100:103:128271917144396::NO:103_GUIDE:5

五和养生堂

原酒言 发表于 2024-1-12 17:14
抱歉才看见，不知道你弄完了没有。
不用做产品列名，它是那个啥，创立CDERdirect账户的时候现在要选Esta ...

好哒，谢谢亲

ouyang311a

感谢

7Dmnz2ialk

提问：是实际的药品生产企业要有FEI号，委托生产的持证商需要申请这个FEI 吗？求解答

偶尔范范小糊涂

7Dmnz2ialk 发表于 2024-4-23 14:47
提问：是实际的药品生产企业要有FEI号，委托生产的持证商需要申请这个FEI 吗？求解答

通常是生产商需要

7Dmnz2ialk

7Dmnz2ialk 发表于 2024-4-23 14:47
提问：是实际的药品生产企业要有FEI号，委托生产的持证商需要申请这个FEI 吗？求解答

感谢感谢，我还是不是很清楚这个流程：
1. sponsor第一次申报FDA NDA，他是自行生产，需要在申报NDA之前完成establishment registration吗？还是拿到批件后再注册。
2. 这个FEI号就是21 CFR中Title 21 Part的这个 Establishment registration number吗？： means the number assigned to the establishment, as identified by FDA, after the establishment registration required in this part.

TMJdb6

7Dmnz2ialk 发表于 2024-4-26 13:50
感谢感谢，我还是不是很清楚这个流程：
1. sponsor第一次申报FDA NDA，他是自行生产，需要在申报NDA之前 ...

问题2：是的

Moonekj

请问辅料的FEI申请流程和药品一样吗

Moonekj

Moonekj 发表于 2024-9-29 09:12
请问辅料的FEI申请流程和药品一样吗

还有必须要美国代理商吗

偶尔范范小糊涂

Moonekj 发表于 2024-9-29 09:12
请问辅料的FEI申请流程和药品一样吗

FEI不分药品和辅料

偶尔范范小糊涂

Moonekj 发表于 2024-9-29 09:19
还有必须要美国代理商吗

非必须