Requirements for clinical documentation for orally inhaled products including requirements for demonstration of therapeutic equivalence between 2 inhaled products for use in treatment of asthma & chronic obstructive pulmonary disease -Scientific guideline

This document clarifies the requirements for clinical documentation for abridged applications for orally inhaled formulations and variations/extensions to a marketing authorisation. It applies to single active substance products and combination products, in respect of the demonstration of therapeutic equivalence between two inhaled products for use in the management and treatment of asthma and chronic obstructive pulmonary disease in adults and the management and treatment of asthma in children and adolescents.

Keywords: Orally inhaled products (OIP)