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  5. Electronic Certificates of Pharmaceutical Product
  1. Human Drug Exports

Electronic Certificates of Pharmaceutical Product

Providing Compliance Documentation to Foreign Entities
Facilities exporting drugs are often asked by foreign customers or foreign governments to provide documentation of the facility’s compliance with FDA requirements.

Issuing Electronic Certificates of Pharmaceutical Product
FDA issues electronic certificate of pharmaceutical product (eCPP) for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. These certificates are provided directly to the requesting country as downloadable PDFs through the CDER Export Certification Application and Tracking System (CDEReCATS). Visit human drug export certificate application instructions for more information.

These certificates provide information about the drug’s U.S. marketing status and the manufacturer’s compliance with FDA’s requirements. These certificates also conform to the World Health Organization (WHO) format and are intended for importing countries considering whether to license drugs for sale in that country. However, FDA does not require export certificates to export human drug products to foreign countries.

Certificates expire 24 months from the date issued after which a new application must be submitted, and certificates cannot be reissued.

The agency does not issue electronic certificates for human drugs that are not exported from the U.S. FDA may return your eCPP application for more information. The Common Reasons FDA Returned an eCPP contains a chart explaining the top reasons.

Accessing an electronic export certificate
An applicant will receive an email notification with instructions on how to access and download an electronic export certificate once it is approved. The recipient will be able to access the certificate at any time via CDEReCATS.

Use FDA Databases to Verify a Drug or Biologic
The agency 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:

  • Orange Book, a public database with information about FDA-approved drugs such as the date of approval
  • data dashboard includes inspection classification information

Fees for Electronic Certificates of Pharmaceutical Product
CDER charges a fee for eCPPs issued within 20 days of receipt of an application, not to exceed $175.00. The agency issues invoices electronically on a quarterly basis. Please contact the Exports User Fee Support Program at EXPORTSUserFeeSupport@fda.hhs.gov with questions about billing.

Contact
CDERexports@fda.hhs.gov

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