Drug Evaluation Committee Impact on Drug Development after Introduction of ICH M11
October 2025
This document presents the findings of a survey and analysis conducted by Task Force 4-2 of the Data Science Subcommittee of the Pharmaceutical Evaluation Committee of the Japan Pharmaceutical Manufacturers Association regarding the impact of the introduction of the ICH M11 guideline “Electronically Structured and Harmonized Clinical Trial Protocol(CeSHarP),” which is scheduled to reach Step 4 in November 2025.
ICH M11 is a guideline aimed at the international standardization and electronic structuring of clinical trial protocols, and its significance extends beyond mere protocol standardization or digitization.Starting with digitized protocols, it has the potential to bring about fundamental transformation across the entire drug development process.
This document provides an explanation of ICH M11 and then details the impact its implementation will have on drug development.With the implementation of ICH M11, clinical trial protocols will be electronically structured, leading to digital transformation (DX) across the entire clinical trial lifecycle—from planning to data collection, analysis, and submission.For example, advancements in data-driven process automation are expected to improve operational efficiency, enhance data quality, and accelerate decision-making.
In addition, this document proposes challenges and preparatory steps that pharmaceutical companies should address prior to the implementation of ICH M11. Furthermore, it introduces the latest global trends and initiatives by relevant organizations such as TransCelerate, CDISC, and HL7, incorporating information from a global perspective.
With the upcoming implementation of ICH M11 and the subsequent adoption of data-driven processes on the horizon, the pharmaceutical industry as a whole is required to respond swiftly. We hope this document will assist companies in their strategic planning and practical implementation efforts.
- *Senior management and those who wish to grasp the big picture first are encouraged to read the Executive Summary included at the beginning of this document to understand the overall scope and significance of ICH M11.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2024 TF4-2