CDER launched a new electronic system called CDER Export Certification and Tracking System (CDEReCATS). CDEReCATS will allow users to request a CDER CPP online as an alternative to a paper submission. We expect that CDEReCATS will offer several benefits, including a possible reduction in certificate processing time, a guided step-by-step application process, real-time validation of data, and e-mail notifications of status updates for the CPP request.
In order to access CDEReCATS, a firm must have a FURLS account ID and password from the FDA Industry Systems/FDA Unified Registration and Listing Systems (FURLS) at the following link: https://www.access.fda.gov/oaa/. Firms that do not have FURLS accounts should consult the “NEW USER” section of the FDA Industry Systems/FURLS website for instructions.
After you have a FURLS account set up, you can submit your CPP request. Once you access the system, you may be asked to upload attachments depending upon the type of drug CPP you are requesting. The attachments may include pictures of drug labels (immediate package and outer package), approval letters, formulation pages, product inserts, etc. CDEReCATS will guide you through the process and direct you to the appropriate application information.
CDER would prefer that you submit your CPP request electronically. Applying for an export certificate using the online CDEReCATS portal will likely reduce the certificate processing time, however, if the user still wishes to apply for a CPP by paper submission, please use Form FDA 3613f
- Access to Online Account Administration (OAA) and CDEReCATS: https://www.access.fda.gov/oaa/
- Slidedeck on CDEReCATS Application Process:
- How to apply for CDER CPP – Approved Drug/Foreign Exported Drug (PDF - 3.48 KB)
- How to apply for a CDER CPP –Over the Counter Drug (OTC) following FDA monograph or approval (PDF - 3.86 MB)
- How to apply for CDER CPP—Active Pharmaceutical Ingredient (API) (PDF - 5.63 MB)
- How to apply for a CDER CPP –Unapproved Drug (PDF - 5.65 MB)
- CDEReCATS general Help document (PDF - 1.41 MB)