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February 8, 2026
Approximately 5 minutes
Current Good Manufacturing Practice Declarations for Human Drug Exports by the U.S. FDA
Current Good Manufacturing Practice Declarations for Human Drug Exports by the U.S. FDA
1. Purpose of CGMP Declarations
FDA issues letters, called current good manufacturing practice (CGMP) declarations, to foreign regulators that convey CGMP compliance status of establishments FDA has inspected. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
2. When to Request a CGMP Declaration
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. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
3. Request Process
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. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
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.
- 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.
- A request for a CGMP declaration can only be made using CDEReCATS. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
4. Additional Information
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. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
Foreign regulators also can find the CGMP status of an establishment by checking the FDA Data Dashboards for the most recent inspection classification. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
5. Contact
For questions or support, contact CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/current-good-manufacturing-practice-declarations
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