Exporting Investigational New Drugs from the U.S. under FDA Regulations

1. Overview

Drugs made in the U.S. are not always approved by FDA but may be approved by regulatory authorities in other countries. Exporters must comply with U.S. federal law when exporting drugs the agency has not reviewed for safety, effectiveness or quality. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

2. Export to Listed Countries

Section 802(c) of the Federal Food Drug and Cosmetic Act permits a company to export an unapproved drug for investigational use to any of the listed countries without prior FDA approval or even an IND. The listed countries are Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and the countries in the European Union (EU) and the European Economic Area (EEA). The drug is required to be exported in accordance with the laws of the foreign country and comply with the basic export requirements in section 802(f) of the FD&C Act. The exporter must maintain records of all drugs exported and the countries to which they were exported. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

3. Exporting INDs under 21 CFR 312.110(b)

The requirements under 21 CFR 312.110(b) apply to exports of drugs for investigational use in unlisted countries where the drug has not received valid marketing authorization in a listed country. 21 CFR 312.110(b) describes four mechanisms for exporting an investigational new drug, and any person who intends to export an unapproved drug for use in a clinical investigation must have either an IND or submit a written request to the FDA. The manufacturer also must be willing to supply the drug. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

4. Exporting INDs under 21 CFR 312.110(b)(1)

Under 21 CFR 312.110(b)(1), an IND may be exported to any country if the clinical trial in the importing country is covered by an IND application. This means the clinical trial in the importing country will comply with FDA’s requirements. Each person receiving the IND that will ultimately be given to a patient must be an investigator in a study submitted to FDA and allowed to proceed. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

5. Exporting INDs under 21 CFR 312.110(b)(2)

Under 21 CFR 312.110(b)(2), an IND can be exported from the U.S. to any country for investigational use if the drug has marketing authorization in the “listed countries” or countries in the EU or EEA. Additional requirements apply to the export, including recordkeeping requirements found in 21 CFR 1.101. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

6. Exporting INDs under 21 CFR 312.110(b)(3)

Under 21 CFR 312.110(b)(3) an IND may be exported to “listed countries,” or countries in the EU and EEA. Additional requirements apply to the export, including recordkeeping requirements found in 21 CFR 1.101. Drugs that are not the subject of an IND are exempt from the label requirement in 21 CFR 312.6(a). Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

7. Exporting INDs under 21 CFR 312.110(b)(4)

Under 21 CFR 312.110(b)(4), an IND may be exported from the U.S. to any country upon the exporter’s submission of a certification to FDA stating the drug and the export meet certain specified conditions. The exporter is responsible for submitting the certification to FDA at the time the drug is first exported. FDA approval for export is not required, and the export may occur once the certification is submitted. Written certifications for export under 21 CFR 312.110(b)(4) should be submitted to CDER’s Exports Compliance Branch at CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs

8. Contact

For questions contact CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/exporting-investigational-new-drugs