ICH M15 Guideline was established to harmonise Model-Informed Drug Development General Principles (MIDD). The overarching guideline is expected to cover the general principles and good practices for the use of MIDD and will harmonise expectations regarding documentation standards, model development, data used in the analysis, model assessment, and its applications. While the original E6(R3) Concept Paper stated that before the drafting of Annex 2, its scope would be further clarified, to define the nature of trials involved, in an update to the Concept Paper, the EWG subsequently determined that a separate Concept Paper was preferred for Annex 2. Further to this, an Annex 2 Concept Paper was approved in May 2023 by the ICH MC, and an E6(R3) EWG Annex 2 Sub-group was established to begin development of Annex 2.

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