Table I.
International Regulatory Authorities and Respective Bioequivalence Guidelines on Inhalation Drug Products
| International regulatory authority | Agency | BE guidelines referenced | Scope | Date posted/effective |
|---|---|---|---|---|
| Australia | Therapeutic Goods Administration (TGA) | Guidance 19: Inhalation and nasal medicines/19.2 Generic MDI (13) | Support applications to register new inhalation and nasal medicine; applications to register generic inhalation and nasal medicines; requests to vary registered inhalation and nasal medicines Include medicines for treating asthma; chronic obstructive pulmonary disease (COPD), other conditions of the lungs |
August 9, 2013 |
| Also refer to EMA guidance on bioequivalence guideline for abridged orally inhalation drugs | See EMA guidance | See EU | ||
| Canada | Health Canada (HC) | Release of the Draft Guidance Document Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma for Industry (2) | Support Abbreviated New Drug Submissions (ANDS); Supplemental New Drug Submissions (SNDS) Include medicines for: corticosteroid for asthma treatment (not COPD) |
September 19, 2011 |
| Guidance to Establish Equivalence or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered-Dose Inhaler (MDI) (7) | Short-acting beta2-agonist metered-dose inhaler only | February 1, 1999 | ||
| Guidance For Industry Pharmaceutical Quality of Inhalation and Nasal Products (section Regional information) (8) | Addresses quality aspects of new marketing authorization applications (including for generic products) and does not outline expected quality aspects related to changes in existing inhalation and nasal products Includes products for administration of the drug substance to the lungs, such as pressurized MDI, DPI, products for nebulization, and non-pressurized MDIs, as well as pressurized metered-dose nasal sprays, nasal powders, and nasal liquids |
October 1, 2006 | ||
| European Union (EU) | European Medicines Agency (EMA) | Doc. Ref. CPMP/EWP/4151/00 Rev. 1—Guideline on The Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence 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 (4) | Recommendations for demonstration of therapeutic equivalence between two inhaled products, in the context of abridged applications or variations/extensions to a marketing authorization, used in the management and treatment of adult patients with asthma and/or COPD and children and adolescents with asthma Include dosage forms: pressurized MDI; breath-operated MDI; pressurized MDI with spacers or holding chambers; non-pressurized MDI; solution and suspensions for nebulization; DPIs |
January 22, 2009 |
| United States of America (USA) | Food and Drug Administration (FDA) | Draft Bioequivalence Recommendations for Specific Product: Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Inhaler (FP-SX DPI) (14) | For FP-SX DPI | September 2013 |
| Draft Bioequivalence Recommendations for Specific Product: Nebulized Budesonide Inhalation Suspension (15) | For nebulized budesonide inhalation suspension | September 2012 | ||
| Draft Bioequivalence Recommendations for Specific Product: Albuterol Sulfate Metered-Dose Inhaler (16) | For albuterol sulfate MDI | June 2013 |
BE bioequivalence, MDI metered-dose inhaler, EMA European Medicines Association