The guideline on the pharmaceutical quality of inhalation and nasal medicinal products
(EMEA/CHMP/QWP/49313/2005 Corr) (which is under revision) covers, as the title indicates, both orally inhaled products (OIPs) and nasal products. For OIPs there is a guideline, i.e., the guideline on the requirements for clinical documentation for OIPs including the requirements for demonstration of therapeutic equivalence (TE) between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1) (also under revision) where all aspects related to TE are discussed…
