Requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Scientific guideline

This guideline replaces "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 (CPMP/EWP/4151/00 Rev.1)”. 

The previous version of the document clarified 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: inhalation, orally inhaled products, therapeutic equivalence, asthma, chronic obstructive pulmonary disease (COPD)

Current version - currently under consultation

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Draft: consultation closedConsultation dates: 12/04/2024 to 30/10/2024Reference Number: EMA/CHMP/101453/2024Summary:

This guideline replaces "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 (CPMP/EWP/4151/00 Rev. 1). 

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Current effective version

Guideline on the requirements for clinical documentation for Orally Inhaled Products including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in treatment of asthma and chronic obstructive pulmonary...

AdoptedReference Number: CPMP/EWP/4151/00 Rev. 1Legal effective date: 01/08/2009

Document history - Revision 2

Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled prod...

Draft: consultation closedConsultation dates: 22/03/2017 to 30/06/2017Reference Number: EMA/CHMP/267194/2016Summary:

This concept paper concerns a revision of the guideline directed to the requirements for demonstration of therapeutic equivalence between two inhaled products. The guideline focuses on hybrid applications but may be applicable also for other applications that are based on demonstration of therapeutic equivalence compared to a reference product, such as line extensions and variations. The guideline was originally published in September 2000 and was revised between September 2007 and January 2009 (henceforth referred to as Revision 1).

Document history - Revision 1 (current version)

Guideline on the requirements for clinical documentation for Orally Inhaled Products including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in treatment of asthma and chronic obstructive pulmonary...

AdoptedReference Number: CPMP/EWP/4151/00 Rev. 1Legal effective date: 01/08/2009

Overview of comments received on 'Guideline on the Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled pro...

Reference Number: EMEA/CHMP/EWP/187653/2009

Draft 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 treatme...

Draft: consultation closedReference Number: CPMP/EWP/4151/00 Rev. 1

Appendix 1 - Draft 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 treatme...

Draft: consultation closedReference Number: EMEA/CHMP/EWP/48501/2008

First version

Points to consider on the requirements for clinical documentation for Orally Inhaled Products (OIP)

AdoptedReference Number: CPMP/EWP/4151/00Legal effective date: 01/10/2004