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# ICH M11 Technical Specification Guidance Out
- URL: https://www.fdaweb.com/ich-m11-technical-specification-guidance-out/
- Published: 2025-06-05T12:00:00.000Z
- Updated: 2026-09-14T15:13:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159309

FDA has published the International Council for Harmonization (ICH) Clinical Electronic Structured Harmonized M11 Technical Specification guidance. The [document](https://www.fda.gov/media/186814/download?ref=fdaweb.com) says its purpose is to be a technical representation of the ICH M11 protocol template. “This technical specification is aligned with the latest version of the ICH M11 guideline and protocol template, but with flexibility in addressing data exchange needs per ICH and those of regional authorities,” it says.