The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted (Step 4 of the ICH harmonisation process) and will now enter the implementation phase (Step 5).
Prior to the development of the M15 Guideline, a lack of common standards meant that the integration of model-informed drug development (MIDD) varied between regulatory authorities and even within a given authority.
While ICH has developed nearly a dozen guidelines that directly or indirectly relate to particular aspects of MIDD, there has been no overarching guideline of general principles, resulting in uncertainty about the acceptability of MIDD among all regulators globally. This has led to differences in the quality of MIDD applications and documentation in regulatory submissions, particularly when it involves novel methods or applications that are not covered in existing, topic-specific ICH Guidelines.
The ICH M15 Guideline covers general principles and good practices for the use of MIDD and harmonises expectations regarding documentation standards, model development, data used in the analysis, and model assessment and its applications.
>> Find the ICH M15 Guideline and associated documents here.