ICH adopts M15 guideline setting general principles for model-informed drug development
The International Council for Harmonisation (ICH) has adopted its M15 Guideline: General Principles for Model-Informed Drug Development (MIDD) at Step 4 of the harmonisation process. The guideline will now move to the implementation phase (Step 5). Although ICH has previously issued guidelines that address specific aspects of MIDD, there has been no overarching guideline setting out general principles. This has contributed to uncertainty about the global regulatory acceptability of MIDD and has led to variation in the quality of MIDD applications and documentation in regulatory submissions, particularly where novel methods or applications are involved that are not addressed by existing, topic-specific ICH guidelines. The ICH M15 Guideline sets out general principles and good practices for the use of MIDD and is intended to harmonise regulatory expectations relating to documentation standards, model development, the data used in analyses, and model assessment and application.