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FDA presenter says ICH M13A is "significant step" for harmonizing bioequivalence study approaches
Summary
An FDA presenter summarized ICH M13A guidance, which classifies solid oral immediate‑release drug products as high‑risk or non‑high‑risk and explains how that classification affects bioequivalence (BE) study design and FDA PSG recommendations.
An agency official summarized the new ICH M13A guidance and its implications for generic drug bioequivalence (BE) assessments, calling the guidance "a significant step forward in harmonizing the bioequivalence study approaches across the various agencies, specifically for solid oral immediate release dosage forms." The presenter said ICH M13A provides a binary classification of products as high‑risk or non‑high‑risk that shapes what BE studies are recommended.
The presenter detailed that the classification depends on drug biopharmaceutic properties (solubility/BCS), formulation and manufacturing complexity (for example, solid dispersions or nanotechnologies), the presence of critical excipients in the reference listed drug (RLD), and dosing/food‑effect instructions on the RLD label. She stressed that these factors determine whether a product is likely to show clinically meaningful differences under fed versus fasting conditions, which in turn affects whether a fed BE study is necessary.
