The FDA CDER Export Certificate Program is being modernised, with a move soon to electronic Certificate of a Pharmaceutical Product (eCPPs).
Who are the end users of CPPs?
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.
What information do CPPs [provide?
CPPs provide information concerning a product’s regulatory or marketing status. It should be noted that FDA does not require export certificates/CPPs to export human drug products to foreign countries.
When is the move to eCPPs happening?
The move to eCPPs is happening on On 3 December 2021.
From this date, the FDA Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs).
- From this date, will no longer issue or mail paper CPPs.
- CPP applications received prior to 3 December 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 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.
The change from paper to electronic certificates is expected to improve efficiency in issuing CPPs, reduce delivery time for export certificates and decrease impact on the environment.
Planned future enhancements in spring 2022
- 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 that this will enable faster exportation processing from the U.S. to the importing country.
You can read more about CPPs in this post.
Source: FDA website
These changes are long overdue and will appreciated by many. Some of the important benefits from these changes include:
- Significant reduction in delivery time from ordering to delivery of CPP to recipient country. This will hopefully mean that marketing authorisation applications and other applications will not get held up unnecessarily from progressing because a CPP should be made available quite quickly
- It should help to free up significant resources for pharma companies, as large amounts of time and money are spent in preparing for, ordering, legalising and authenticating and couriering paper CPPs.
Hopefully, other regulatory agencies will adopt the FDA approach sometime soon and put an end to the bureaucratic, unnecessary and wasteful exercise of having to legalise and authenticate CPPs, once and for all.
Source: FDA website