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  5. Exporting Investigational New Drugs
  1. Human Drug Exports

Exporting Investigational New Drugs

Export Requirements

Export requirements apply to investigational new drugs (INDs) as follows:

Exporting Investigational New Drugs to a Listed Country

Section 802(c) of the Federal Food Drug and Cosmetic Act (21 USC § 382) 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, under section 802(g) of the FD&C Act, must maintain records of all drugs exported and the countries to which they were exported.

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.

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.

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.

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).

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.

The agency does not offer a template or model document for the certification. The certification must describe the drug to be exported, i.e., trade name (if any), generic name and dosage form, identify the country to which the drug will be exported and affirm the following:

  • The drug is intended for export
  • The drug is intended for investigational use in a foreign country
  • The drug meets the foreign purchaser's or consignee's specifications
  • The drug is not in conflict with the foreign country's laws
  • The outer shipping package is labeled to show that the drug is intended for export from the U.S.
  • The drug is not sold or offered for sale in the U.S.
  • The clinical investigation will be conducted in accordance with § 312.120
  • The drug is manufactured, processed, packaged and held in substantial conformity with current good manufacturing practice requirements
  • The drug is not adulterated within the meaning of section 501(a)(1), (a)(2)(A), (a)(3), (c), or (d) of the FD&C Act
  • The drug does not present an imminent hazard to public health, either in the U.S., if the drug were to be reimported, or in the foreign country
  • The drug is labeled in accordance with the foreign country’s laws

Contact

CDERexports@fda.hhs.gov

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