Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract†

Adopted by the TGA: 13 March 2025

Overseas effective date: 18 October 2018

Addendum: This guideline is an addendum to the ‘Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents' (CPMP/EWP/239/95). (Adopted by the TGA in 2011) 

Categories: Clinical efficacy and safety | clinical pharmacology and pharmacokinetics

                     Clinical efficacy and safety | General 

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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For more information see International scientific guidelines adopted in Australia