Modernization of the FDA CDER Export Certificate Program
On Dec. 3, 2021, the FDA Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer issue or mail paper CPPs. CPP applications received prior to Dec. 3, 2021, will be issued as paper certificates. The eCPPs for human drug products will be issued as downloadable PDFs through the CDER Export Certification Application and Tracking System (CDER eCATS). The change from paper to electronic certificates will improve efficiency in issuing CPPs, reducing delivery time for export certificates and decreasing impact on the environment.
Manufacturers exporting products from the U.S. are often asked by foreign customers or foreign governments to supply an export certificate, known as a CPP, for FDA-regulated products. CPPs provide information concerning a product’s regulatory or marketing status. FDA does not require export certificates/CPPs to export human drug products to foreign countries.
After Dec. 3, 2021, how will a firm request and access an eCPP/export certificate electronically?
When the eCPP is approved, the applicant will receive an email notification with instructions on how to access and download the eCPP. The recipient will be able to access eCPP at any time via CDER eCATS.
The process for CPP submissions has not changed. Firms will continue to use CDER eCATS to submit CPP applications and will be asked to provide an email address for delivery of the eCPP. Foreign governments can continue to verify the authenticity of a manufacturer’s export certificate through their CDER eCATS account.
What are planned future enhancements?
In spring 2022, foreign governments will be able to verify the authenticity of a manufacturer’s eCPP/export certificate through the FDA Unified Registration and Listing System Export Certificate Validator (FECV) website. FDA will add a unique Quick Response (QR) code to the eCPP/export certificate. Foreign governments can reach the FECV site by scanning the QR code on the eCPP. The user then verifies the eCPP by entering the unique eCPP number on the FECV website. The FDA anticipates this will enable faster exportation processing from the U.S. to the importing country.
Will this change the content of the export certificate?
There will be no other changes to the format or content of the certificate. The only change to the appearance of the export certificate will be the addition of the QR code.
If you have any questions regarding this procedural change, please contact the Center for Drug Evaluation and Research at CDERExportCertificateProgram@fda.hhs.gov.
For more information:
- Certificates of Pharmaceutical Product: General Information
- CDER eCATS
- CDER eCATS User Guide: Step-by-Step Instructions for Industry Applicants
- Human Drug Export Certificate Application Instructions
- FDA Export Certification Guidance
- FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996
- The Federal Food Drug and Cosmetic Act (Sections 801 and 802)