Bioequivalence for immediate-release solid oral dosage forms – M13A

We have adopted this International Scientific Guideline- ICH M13 A

About this guideline

Adopted by the TGA: 13 March 2025

Overseas adoption date: 23 July 2024

Categories: ICH | Multidisciplinary

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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