On December 3, 2021, the U.S. Food and Drug Administration’s (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.
From paper to electric
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 the amount of time it takes to receive export certificates, and decrease environmental burden.
Requesting a CPP
The process for CPP submissions has not changed. Firms will continue to utilize 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.
The applicant will receive an email notification when the eCPP is approved containing instructions on how to access and download the eCPP. The recipient will be able to access eCPP at any time via CDER eCATS.
Foreign Governments Verification of eCPP
Coming up 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.
What is a cpp?
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 products regulated by the FDA.
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.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.