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# FDA Releases Revised ICH Efficacy Format Guidance
- URL: https://www.fdaweb.com/fda-releases-revised-ich-efficacy-format-guidance/
- Published: 2017-07-24T12:00:00.000Z
- Updated: 2026-09-14T22:36:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139197

FDA has issued a revised International Council for Harmonization [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM465221.pdf?ref=fdaweb.com) on “M4E(R2): The CTD — Efficacy.” The document provides recommendations for applicants preparing the Common Technical Document (CTD) for submissions to the agency. It presents the agreed-upon common format that will be accepted in the ICH regulatory regions for the preparation of a well-structured Efficacy section of the CTD, the document says.  
  
This guidance mainly addresses the information organization contained in the efficacy section of an application for new pharmaceuticals or biologics and “indicates an appropriate format for the data that have been acquired,” FDA says. “Applicants should not modify the overall organization of the CTD. However, in the Nonclinical and Clinical Summaries sections of the CTD, applicants can modify individual formats, if needed, to provide the best possible presentation of thetechnicalinformation to facilitate the understanding and evaluation of the results.”