Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline

This guideline is an addendum to the Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents - First version(CPMP/EWP/239/95). The guidance defines requirements for the clinical development of locally applied, locally acting products with known active substance. It provides guidance on the information to be included in the dossier.

Keywords: Therapeutic equivalence, gastrointestinal, locally applied and locally acting, pharmacokinetic, bioequivalence

Current effective version

Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1

Adopted Reference Number: CPMP/EWP/239/95 Rev. 1 Corr. Legal effective date: 30/04/2019 Summary:

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).

Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents - First version

Adopted Reference Number: CHMP/EWP/239/95 final Legal effective date: 01/06/1996

Document history

Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1

Adopted Reference Number: CPMP/EWP/239/95 Rev. 1 Corr. Legal effective date: 30/04/2019 Summary:

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).

Overview of comments received on 'Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract' (EMA/CPMP/EWP/239/95 Rev.1) - Revision 1

Reference Number: EMA/CHMP/648051/2017

Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guidance CHMP/EWP/239/95 - Revision 1

Draft: consultation closed Consultation dates: 04/04/2017 to 30/09/2017 Reference Number: CPMP/EWP/239/95 Rev. 1 Summary:

This guideline defines the requirements that need to be fulfilled to waive clinical trials with clinical or pharmacodynamic endpoints in the demonstration of therapeutic equivalence for locally applied, locally acting gastrointestinal products. It also defines the in vivo bioequivalence studies and in vitro equivalence tests that are necessary.

Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract - Revision 1

Draft: consultation closed Consultation dates: 01/10/2013 to 31/12/2013 Reference Number: EMA/CHMP/558326/2013 Summary:

The note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents provides general recommendations on the clinical requirements for respective formulations with known active substances. This concept paper discusses the need to expand the guidance on locally applied and locally acting gastrointestinal products.