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.
Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requesting country. CPPs conform to the format established by the World Health Organization (WHO) and are intended for use by importing countries when considering whether to license the product in question 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
CPPs are printed on security paper and contain the signature of the authorized FDA official, embossed federal seal and ribbon.
FDA is authorized to charge a fee for CPPs issued within 20 days of receipt of an application, not to exceed $175.00. The fees are:
- First certificate for the same country in the same application ..... $175.00
- Second certificate for the same country in the same application ..... 90.00
- Third and subsequent certificates for the same country in the same application ..... 40.00
Please do not send payment with the application; invoices are issued quarterly. CPP applications may be submitted using the CDER export certification and tracking system (CDEReCATS) online portal.
For inquiries about CPPs, please e-mail CDERExportCertificateProgram@fda.hhs.gov or call 301-796-4950.