Facilities exporting human drugs are often asked by foreign customers or foreign governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements.
FDA issues electronic certificates of pharmaceutical product (eCPP) for human drugs exported from the U.S. directly to the requesting country. FDA eCPPs conform to the World Health Organization (WHO) format and are intended for importing countries considering whether to license products for sale in that country. Certificates expire 24 months from the date issued after which a new application must be submitted. Certificates cannot be reissued.
FDA has published resources that enable stakeholders to verify whether a drug or biologic is FDA approved and to view FDA’s classifications of its inspections of foreign facilities:
- FDA’s Orange Book, a public database with information about FDA-approved drugs such as the date of approval
- FDA’s inspection classification database, where stakeholders can find the most recent inspection classification of an establishment
- FDA’s letters that are issued within 90 days of an inspection to the establishment and indicate the agency’s inspection classification of the establishment
FDA charges a fee for eCPPs issued within 20 days of receipt of an application, not to exceed $175.00.
Please note that invoices are issued electronically on a quarterly basis. For billing questions, please contact the Exports User Fee Support Program: EXPORTSUserFeeSupport@fda.hhs.gov.
Exporting facilities may submit eCPP applications through the CDER export certification and tracking system (CDEReCATS) online portal.
For inquiries about eCPPs, please e-mail CDERExportCertificateProgram@fda.hhs.gov.