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Investigational New Drug (IND)

Investigational New Drug (IND) is the US Food and Drug Administration programme through which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines, usually to clinical investigators, before a marketing application for the drug has been approved[1].

The regulations for the IND programme are primarily set out in 21 CFR 312[1].

Similar procedures are followed in the European Union, Japan and Canada, because of regulatory harmonisation efforts by the International Council for Harmonisation[1].

Investigational new drugs meant for emergency use or treatment applications, and not for commercial distribution, are not subject to the Common Technical Document requirements[2].

Why it matters to investors

The IND programme is how a company obtains permission to begin human clinical trials, which take place before a marketing application for the drug has been approved[1].

Related: Phase 1 trial, Phase 2 trial, New Drug Application (NDA), Biologics License Application (BLA)

Sources

  1. "E8(R1) General Considerations for Clinical Studies" (PDF) . Efficacy Guidelines . ICH. database.ich.org (via Wikipedia: Investigational New Drug)
  2. Duplessis, Tanya (12 December 2022). "Introduction to CMC and its Considerations" . Bioforum . Retrieved 15 January 2024 . bioforumgroup.com; Research, Center for Drug Evaluation and (14 November 2023). "Investigational New Drug (IND) Application" . FDA . Archived from the original on 2 June 2019 . Retrieved 15 January 2024 . web.archive.org (via Wikipedia: Common Technical Document)

Checked 8 October 2026. How we check sources