FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

ICH Considers Harmonizing Generics Standards Across Borders

Feb. 13, 2019
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The International Council on Harmonization released a reflection paper on harmonizing technical and scientific standards for generic drugs across borders.

In the case of non-complex drugs, policymakers should develop bioequivalence study guidelines for immediate-release oral dosage drugs, ICH says. In the case of more complex products or dosage forms, they should consider “waivers” for different strengths for modified release products.

The paper also suggests guidelines on bioequivalence standards for products with complex API ingredients or complex formulations, as well as for combination products.

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