Understanding 21 CFR 312.120

For emerging and growth-stage biopharmaceutical companies, U.S. market entry remains the ultimate price and toughest proving ground. The FDA’s regulatory pathway is globally recognized as the gold standard, but the barriers are arduous: high-cost pivotal studies, extended timelines, and frequently, the need to reinitiate development at Phase I or II despite robust ex-U.S. clinical data.

What many international firms may overlook, however, is that FDA provides a mechanism to rely on foreign clinical trial data under 21 CFR 312.120. This provision, when strategically leveraged, enables sponsors to utilize Good Clinical Practice (GCP)-compliant, non-IND clinical trial results as the evidentiary basis for an Investigational New Drug (IND) submission or subsequent clinical development in the United States.

Putting your foreign clinical data to work

Although underutilized, this pathway can dramatically reduce development costs and time-to-market. LNE Group has successfully advised sponsors through this process, including securing Study May Proceed (SMP) authorization for a Phase III clinical investigation based exclusively on foreign controlled trial data conducted outside an IND framework.

The process of compiling, validating, and preparing a 21 CFR 312.120 submission can be complex, often adding hundreds or thousands of pages to an IND submission. Sponsors must demonstrate that foreign clinical data are reliable, well-controlled, and consistent with international standards of Good Clinical Practice (GCP). Key elements include:

  • Evidence of GCP compliance, including full documentation of Independent Ethics Committee (IEC)/Institutional Review Board (IRB) determinations.
  • Investigator qualifications, establishing clinical expertise and prior experience.
  • Facility descriptions, detailing the capabilities of trial sites and supporting infrastructure.
  • Study protocol documentation, including trial design, endpoints, and statistical analysis plans.
  • Comprehensive information on the investigational product, covering both the drug substance and finished drug product.
  • Monitoring and quality assurance procedures, ensuring oversight, data integrity, and patient safety.
  • Investigator training records, particularly for multi-center or multi-jurisdictional trials.

Contact Jason Smith, Senior Vice President of Strategic Advisory at JSmith@LNEGroup.com for more information

By partnering with us, your organization can optimize existing clinical assets, streamline regulatory strategy, and accelerate U.S. commercialization while maintaining full compliance with FDA standards.