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Guideline on the requirements for clinical documentation for orally inhaled products (OIP)

Including 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 treatment of asthma in children and adolescents

We have adopted this International Scientific Guideline - CPMP/EWP/4151/00 Rev.1

Last updated

About this guideline

Overseas effective date:  1 August 2009

Replaces: CPMP/EWP/4151/00 (Adopted by TGA January 2005)

Categories: Clinical efficacy and safety | Respiratory system

                        Multidisciplinary | Orally inhaled products

TGA Annotations: Nil

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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