> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Multiregional Clinical Trial Planning Guidance
- URL: https://www.fdaweb.com/multiregional-clinical-trial-planning-guidance/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141902

FDA has issued an International Conference on Harmonization (ICH) guidance, *E17 General Principles for Planning and Design of Multiregional Clinical Trials*, to describe general principles for the planning and design of multiregional clinical trials with the aim of increasing the acceptability of such trials in global regulatory submissions. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM519603.pdf?ref=fdaweb.com) addresses strategic program issues and issues that are specific to the planning and design of confirmatory multiregional clinical trials and should be used in conjunction with other specified ICH guidances.