Table VII.

Comparisons of the Bioequivalence Recommendation for Clinical Efficacy Studies for Inhaled Corticosteroids and Bronchodilators from International Jurisdictions

International jurisdictions	Clinical studies for inhaled ICS	Clinical efficacy studies for bronchodilators
Therapeutic Goods Administration	No detail provided	Bronchodilation study is preferred Bronchoprotection study alone is not sufficient but could serve as supporting study
Health Canada	Quantitative sputum eosinophil counts Exhaled nitric oxide (eNO) is also suggested	Bronchodilation and bronchoprotection studies
European Medicines Agency	Bronchodilation and bronchoprotection studies EMA guidance also mentioned in brief that other efficacy variables including expired nitric oxide (eNO) and sputum eosinophils, validated quality of life (QoL) questionnaires, and validated patient-reported outcome measures (PROMs) could also be considered	Bronchodilation and bronchoprotection studies
Food and Drug Administration	A confirmatory clinical study measuring lung function, no dose–response recommendation	Bronchodilation and bronchoprotection studies

ICS inhaled corticosteriods, EMA European Medicines Association