GMP证书

涉水之卒

中国欧盟美国等地有具体的GMP证书吗？

wzzz2008

早就没有了。

Neuro_psycho

MDSAP 或者 13485证书替代

AUTOZAI

Issuing Current Good Manufacturing Practice Declarations
FDA issues letters, called current good manufacturing practice (CGMP) declarations, to foreign regulators that convey CGMP compliance status of establishments FDA has inspected.

Facilities located in the U.S. that have been included as part of a marketing application submitted to a foreign regulator request the letter from FDA. The agency then issues a letter directly to an identified foreign regulator conveying the CGMP compliance status for the facility within 30 days of receipt of the request.

FDA also Issues Certificate of Pharmaceutical Product (CPP)
A CGMP declaration should only be requested if a foreign regulator does not accept a valid certificate of pharmaceutical product (CPP) and wants additional assurance of a facility’s CGMP status.

CGMP declarations are one of several ways that FDA is enhancing communication and transparency with foreign regulatory authorities regarding the compliance status of establishments in the U.S. Foreign regulators also can find the CGMP status of an establishment by checking the FDA Data Dashboards for the most recent inspection classification.

Requesting a CGMP Declaration
An establishment may request a CGMP declaration using the agency’s online application process, CDER Export Certification Application and Tracking System (CDEReCATS), under the following conditions:

An establishment can only request the CGMP status for its own site. Parent and affiliate companies may not request a declaration for an establishment.
An establishment requesting a CGMP declaration must have the latest inspection conducted by the FDA as acceptable.
A requesting establishment must have previously obtained a CPP prior to requesting a CGMP declaration or be able to provide a CPP number in which the establishment is included. This CPP does not need to be for the drug product for which the declaration is being sought but the CPP must be valid and not expired at the time of the declaration request.
A request for a CGMP declaration can only be made using CDEReCATS. To access CDEReCATS, an establishment must have an FDA Industry System/FDA Unified Registration and Listing Systems (FURLS) account ID and password. Manufacturers that do not have a FURLS account may create a new account.
A CGMP declaration application must include an email address for the foreign regulator. If the CGMP is issued, it will be sent directly to the foreign regulator’s email provided in the application.
These letters were part of FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II), and as part of GDUFA III.

发布当前良好生产规范声明
FDA向外国监管机构发出称为当前良好生产规范（CGMP）声明的信函，传达FDA检查过的场所的CGMP合规状态。

在美国，作为向外国监管机构提交的市场申请的一部分，向FDA申请该信件。随后，机构会在收到请求后30天内，直接向指定的外国监管机构发出函件，告知该设施的CGMP合规状态。

FDA还颁发药品证书（CPP）
只有当外国监管机构不接受有效的药品制品证书（CPP）并希望获得对设施CGMP身份的额外保证时，才应申请CGMP声明。

CGMP声明是FDA加强与外国监管机构沟通和透明度，了解美国机构合规状况的多种方式之一。外国监管机构也可以通过查询FDA数据仪表盘中最新的检查分类来查询机构的CGMP状态。

请求CGMP声明
机构可通过机构的在线申请流程——CDER出口认证申请与跟踪系统（CDEReCATS）申请CGMP申报，条件如下：

机构只能为自己的站点申请CGMP身份。母公司及关联公司不得为企业申请声明。
申请CGMP声明的机构必须获得FDA最新检查结果为可接受。
申请机构必须在申请CGMP声明前先获得CPP，或能够提供包含该机构的CPP号码。该CPP不必适用于申请声明的药品，但CPP必须有效且在申请声明时未过期。
CGMP申报的请求只能通过CDEReCATS提出。要访问CDEReCATS，机构必须拥有FDA行业系统/FDA统一注册与上市系统（FURLS）账户ID和密码。没有FURLS账户的制造商可以创建新账户。
CGMP声明申请必须包含外国监管机构的电子邮件地址。如果发出CGMP，将直接发送到申请中提供的外国监管机构邮箱。
这些信件是FDA根据2017年仿制药用户费用修正案（GDUFA II）以及GDUFA III的一部分承诺的一部分。

https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations

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KMT

只剩中国特有了

Hongy6p

KMT 发表于 2025-12-9 07:59
只剩中国特有了

中国现在还有吗

1546175169

都已经被取消了 好吧