EMA: 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

The note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [in the following called ‘guideline’] 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.