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Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD)

We have adopted this International Scientific Guideline - EMA/CHMP/483572/2012 - corr1.

Last updated

About this guideline

Overseas effective date:  1 September 2012

Replaces: CPMP/EWP/562/98. Points to Consider on Clinical Investigation of Medicinal Products in the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD), and concept paper EMEA/CHMP/EWP/8197/2009 on this topic (provided for information 1 May 2009) 

Categories: Clinical efficacy and safety | Respiratory system

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.
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For more information see International scientific guidelines adopted in Australia.

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