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  5. Human Drug Export Resources for Foreign Governments
  1. Human Drug Exports

Human Drug Export Resources for Foreign Governments

Resources for Foreign Governments
FDA works to help assure safe and quality drugs are exported from the U.S. for use around the world. The agency reviews thousands of electronic certificate of pharmaceutical product (eCPP) applications a year. On average, FDA’s Center for Drug Evaluation and Research issues more than 8,500 export certificates a year to foreign governments. The countries with the highest volume of drug exports are Mexico and China.

The following resources for foreign governments highlight FDA’s work to help assure safety and quality:

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 quality of the drugs they import and export. The scheme has been in operation since 1969 and has been amended several times. CDER conforms to this scheme as it currently works 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: Regulation and Prequalification (who.int).

FDA Inspection Classification and Compliance Status Databases
FDA publishes final classifications for certain inspections, including human drug inspections which assess compliance with current good manufacturing practice requirements. You can find this information on the FDA data dashboard. Inspection classifications are part of CDER’s review process when issuing eCPPs for human drug products that are exported from the U.S.

How to verify whether a drug or biologic is FDA approved:

  • FDA’s Orange Book is a public database with information about FDA-approved drugs such as the date of approval.
  • OTC products that conform to an FDA monograph.

Verifying eCPPs
Visit the FDA Unified Registration and Listing System Export Certification Validator (FECV) portal or scan the quick response (QR) code on the bottom right of the export certificate using your mobile phone camera to verify or authenticate an eCPP. Visit online eCPP verification for more information.

Contact
Email CDERExports@fda.hhs.gov if there is a human drug exports issue pertaining to your country.

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