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

We have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*

About this guideline

Adopted by the TGA: 13 March 2025

Overseas publication date: 18 October 2018

Replaces: Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95)

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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

 

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