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)
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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... (PDF/270.79 KB)
Adopted
First published: 22/01/2009
Last updated: 22/01/2009
Legal effective date: 01/08/2009
CPMP/EWP/4151/00 Rev. 1 -
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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... (PDF/980.35 KB)
First published: 20/09/2010
Last updated: 20/09/2010
EMEA/CHMP/EWP/187653/2009 -
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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... (PDF/176.15 KB)
Draft: consultation closed
First published: 18/10/2007
Last updated: 18/10/2007
CPMP/EWP/4151/00 Rev. 1 -
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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... (PDF/43.85 KB)
Draft: consultation closed
First published: 19/03/2008
Last updated: 19/03/2008
EMEA/CHMP/EWP/48501/2008