Recent regulatory developments for Quantitative Systems Pharmacology and Model-Informed Drug Development
FDA guidance on QSP-based MABEL estimation and the EMA's MIDD pilot reflect increasing international alignment on model-informed regulatory science.
The U.S. FDA’s new guidance establishes Quantitative Systems Pharmacology (QSP) as a vital framework for calculating human starting doses (MABEL), using advanced mathematical modeling to capture complex drug-biological interactions and reduce traditional reliance on animal toxicology.
By embedding QSP into early-stage regulatory review, the FDA strongly reinforces its commitment to Model-Informed Drug Development (MIDD). This guidance aligns well with international counterparts like the European Medicines Agency (EMA)—which actively champions ICH M15 through the activities of its M&S Working Party and MIDD-centric workshops.
More importantly, the explicit reference to Modelling & Simulation, MIDD, and QSP in the EMA’s strategic “Regulatory Science” plans and roadmaps, as well as the recently initiated EMA MIDD pilot program for regulatory decision-making in May 2026, fosters deeper international harmonization.
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