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February 9, 2026
Approximately 5 minutes
Electronic Certificates of Pharmaceutical Product (eCPP) for Human Drug Exports by the U.S. FDA
Electronic Certificates of Pharmaceutical Product (eCPP) for Human Drug Exports by the U.S. FDA
1. Purpose
FDA issues electronic certificate of pharmaceutical product (eCPP) for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. These certificates provide information about the drug’s U.S. marketing status and the manufacturer’s compliance with FDA’s requirements. They conform to the World Health Organization (WHO) format and are intended for importing countries considering whether to license drugs for sale in that country. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
2. When to Request an eCPP
A CGMP declaration or eCPP 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 compliance status. FDA does not require export certificates to export human drug products. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
3. Who Can Request
Facilities located in the U.S. that have been included as part of a marketing application submitted to a foreign regulator may request the letter. The agency issues the eCPP directly to the identified foreign regulator. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
4. Request Process
Submit an application through the CDER Export Certification Application and Tracking System (CDEReCATS). Certificates are provided as downloadable PDFs directly to the requesting country. Visit human drug export certificate application instructions for details. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
5. Fees and Processing
CDER charges a fee for eCPPs issued within 20 days of receipt of an application, not to exceed $175.00. Invoices are issued electronically on a quarterly basis. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
6. Validity and Access
Certificates expire 24 months from the date issued. A new application must be submitted after expiration; certificates cannot be reissued. Applicants receive an email notification with instructions to access and download the certificate. Recipients can access it at any time via CDEReCATS. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
7. Important Notes
FDA does not issue eCPPs for human drugs that are not exported from the U.S. Applications may be returned for more information. Verify drug status using the Orange Book or FDA Data Dashboards. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
8. Contact
For questions contact CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/electronic-certificates-pharmaceutical-product
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