ICH plans model-informed drug development guideline in 3-4 years

Regulatory NewsRegulatory News | 04 May 2022 |  By 

The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches in drug development.
The roadmap, developed by the recently formed ICH MIDD Discussion Group, lays out the harmonization body’s vision for an MIDD general principles guideline, additional MIDD-specific guidelines, and incorporating MIDD-principles and approaches into several of its existing guidelines. (RELATED: ICH MIDD concept paper coming by years-end, Regulatory Focus 20 May 2021)
The goal of MIDD is to make drug development more efficient by integrating data from mathematical and statistical models in predicting a drug’s effects and reducing unnecessary patient exposure.
ICH said the MIDD general principles guideline will seek to “enable a unified approach to model-informed assessments of efficacy and safety for new medicines globally. Based on this, the topic of MIDD has been prioritized for further general and specific ICH guideline development. There was aligned agreement from across the ICH MIDD DG that this harmonization would enable efficiencies for regulators and developers, ultimately benefiting patients.”
While many regulators accept model-based analyses in submissions, the level of integration of these approaches into regulatory decision making varies. The paper notes that the “lack of common documentation standards, consistency in model assessment expectations and understanding of terminology hinders efficient assessment of model-based submissions, including quality of the data used, the robustness of the analysis, vis-à-vis the modeling impact and credibility with respect to its intended applications.”
The group plans to start developing a MIDD General Principles guideline within the next three to four years, and to have a completed guideline ready within ten years. In addition, “specific related appendices or Q&As could be developed and released at the same time a MIDD general principles guideline. However, revisions or updates of existing guidelines would have to be endorsed by the ICH Assembly.”

After a general guideline is published, the DG would focus on incorporating these approaches into existing guidelines. First to be revised, or the guideline the DG assign the highest priority, is the E4 guidance on dose response information to support drug registrations.
“Given the importance of MIDD to many aspects of the ICH E4, this was prioritized to be the next guidance for update or replacement after the MIDD general principles guideline,” the paper notes.
Medium priority was assigned to incorporating this approach into the population pharmacokinetic-pharmacodynamic guidelines under E5, E7, E14(R3) and E17. A low priority is assigned to incorporating these principles into the guideline on disease progressing modeling, as well as the guideline on physiologically based pharmacokinetic (PBPK) modeling and simulation.
MIDD roadmap


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