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February 13, 2026
Approximately 5 minutes
U.S. FDA Human Drug Export Resources for Foreign Governments
U.S. FDA Human Drug Export Resources for Foreign Governments
1. Overview
FDA assists foreign governments in ensuring safe and quality drugs are exported from the U.S. for global use. The agency reviews thousands of electronic certificates of pharmaceutical product (eCPP) applications annually. On average, FDA’s Center for Drug Evaluation and Research (CDER) issues more than 8,500 export certificates per year to foreign governments. The countries with the highest volume of drug exports are Mexico and China. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-resources-foreign-governments
2. Harmonization Efforts
The World Health Organization (WHO) Certification Scheme on the quality of pharmaceutical products in international commerce is a voluntary international agreement designed to assure participating countries of the quality of drugs they import and export. The scheme has been in operation since 1969 and has been amended several times. CDER conforms to this scheme by issuing a certificate of pharmaceutical product (CPP) for quality assurance. The WHO provided an update on the use of e-signature for certificates using the WHO certification scheme. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-resources-foreign-governments
3. Inspection Classification and Compliance Status
FDA publishes final classifications for certain inspections, including human drug inspections which assess compliance with current good manufacturing practice requirements. This information is available on the FDA data dashboard. Inspection classifications are part of CDER’s review process when issuing eCPPs for human drug products exported from the U.S. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-resources-foreign-governments
4. Verification of FDA Approval Status
Foreign governments can verify whether a drug or biologic is FDA approved using FDA’s Orange Book, a public database with information about FDA-approved drugs such as the date of approval. OTC products that conform to an FDA monograph are also listed. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-resources-foreign-governments
5. eCPP Verification Tools
Foreign regulators can verify eCPPs by visiting the FDA Unified Registration and Listing System Export Certification Validator (FECV) portal or scanning the quick response (QR) code on the bottom right of the export certificate using a mobile phone camera. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-resources-foreign-governments
6. Contact for Assistance
Foreign governments can email CDERExports@fda.hhs.gov if there is a human drug exports issue pertaining to their country. Source: https://www.fda.gov/drugs/human-drug-exports/human-drug-export-resources-foreign-governments
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