 October 18, 2021
Dear International Colleague,
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) is shifting to an electronic version of Certificates of Pharmaceutical Product (CPP).
Starting on December 3, 2021, all CPPs will be issued electronically, and paper CPPs will no longer be issued or mailed. All CPP applications received PRIOR to December 3, 2021, will be issued as paper certificates.
Manufacturers exporting human drug products from the U.S. are often asked by foreign customers or foreign governments to supply an "export certificate," or CPP, for products regulated by the FDA. CPPs provide information concerning a product’s regulatory or marketing status.
The certificates are issued directly to the requesting country and conform to a format established by the World Health Organization. FDA does not require export certificates/CPPs to export human drug products to foreign countries. Rather, these documents are intended for use by the importing countries when considering whether to license the product in question for sale in that country.
The electronic CPPs 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, reduce the amount of time it takes to receive export certificates, and decrease environmental burden.
After December 3, 2021, how will a firm be able to request and access a CPP/export certificate electronically?
The applicant will receive an email notification when the electronic CPP (eCPP) is approved containing instructions on how to access and download the eCPP. The recipient will be able to access the 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 where the eCPP will be sent. 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 FURLS 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 eCPP is then verified by entering the unique eCPP number on the FECV website. The Agency 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:
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