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February 12, 2026
Approximately 5 minutes
U.S. FDA Human Drug Export Certificate Application Instructions Using CDEReCATS
U.S. FDA Human Drug Export Certificate Application Instructions Using CDEReCATS
1. System Access
Facilities must have a FURLS account ID and password to access CDEReCATS. New users can create a new account through the FDA Industry Systems portal. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-certificate-application-instructions
2. Key Benefits
CDEReCATS offers:
- Possible reduction in certificate processing time
- Guided step-by-step application process
- Real-time validation of data
- Email notifications of status updates for CPP requests Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-certificate-application-instructions
3. Application Process
Facilities request Certificates of Pharmaceutical Product or CGMP declarations through the online portal. The system guides users and directs them to upload required attachments such as drug labels, approval letters, formulation pages, or product inserts depending on the certificate type. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-certificate-application-instructions
4. Additional Guidance
Detailed step-by-step instructions are available in the application guide PDF. All applications are submitted electronically via CDEReCATS. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-certificate-application-instructions
5. Important Notes
Only U.S.-located facilities included in a marketing application submitted to a foreign regulator may request these certificates. The system supports both CPP and CGMP declaration requests. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-certificate-application-instructions
6. Contact Information
For questions or support, contact CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-certificate-application-instructions
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