Drug Evaluation Committee Impact on Drug Development after Introduction of ICH M11
Data Science Subcommittee
October 2025
This document is a study by the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) on the impact on drug development and pharmaceutical companies of the introduction of the ICH M11 guideline "Electronically Structured and Harmonized Clinical Study Protocol (CeSHarP)," which is scheduled to reach Step 4 in November 2025. This report summarizes the results of the survey and analysis conducted by Task Force 4-2 of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association.
ICH M11 is a guideline aimed at international standardization and electronic structuring of clinical trial protocols (protocols), and its significance goes beyond mere standardization and computerization of protocols. It has the potential to bring about fundamental changes throughout the entire drug development process, starting with electronic protocols.
This document first provides an overview of ICH M11 and details the impact that its implementation will have on drug development. Digital transformation (DX) will spill over. For example, data-driven process automation is expected to advance, resulting in more efficient operations, improved data quality, and faster decision-making.
In addition, issues and preparatory items that pharmaceutical companies should address in the future prior to the introduction of ICH M11 will also be proposed. In addition, the latest trends overseas and the efforts of related organizations such as TransCelerate, CDISC, and HL7 will be introduced, and information from a global perspective will be included.
The entire pharmaceutical industry is required to take prompt action in anticipation of the future introduction of ICH M11 and the implementation of data-driven processes that lie ahead. We hope that this document will be of some help to companies in their strategic planning and practical responses.
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As of December 2023For senior management level or those who want to understand the whole picture first, please read the Executive Summary included at the beginning of this document to understand the whole picture of ICH M11 and its importance.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee FY2024 TF4-2
Deliverables of the Drug Evaluation Committee Return to list of all deliverables