ICH Project Briefing on ICH M15 "General Principles for Model-Informed Drug Development (Draft)
March 19, 2025
The ICH M15 Expert Working Group (EWG) has been studying to develop a guideline for ICH M15 "General Principles on Model-Informed Drug Development". As a result, ICH M15 "General Principles for Model-Informed Drug Development (Draft)" reached Step 2 as of November 6, 2024, and was published on the official ICH website. In Japan, the call for public comments on ICH M15 "General Principles for Model-Informed Drug Development (Draft)" was launched on February 7, 2025.
In order to promote understanding of the draft guideline and to support the collection of public comments, we have decided to hold a Guideline Workshops on ICH M15 "General Principles for Model-Informed Drug Development (Draft)" in the form of video distribution.
The program and details of the presentation can be viewed on the PMDA website.