Comments invited on guidance on clinical investigation of medicines for the treatment of asthma

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01/07/2013

Comments invited on guidance on clinical investigation of medicines for the treatment of asthma

The European Medicines Agency has published a revised note for guidance on clinical investigation of medicines for the treatment of asthma for a six-month public consultation.

Comments should be made using the submission form and sent no later than 31 December 2013 to respiratorydgsecretariat@ema.europa.eu.

Asthma is a chronic inflammatory disorder of the airways caused by genetic and environmental factors. The condition affects a large percentage of the European population with prevalence rates of clinical asthma ranging between 18.4% in Scotland and 4.9% in Scandinavia and the Baltic States. The duration and intensity of treatment depend on the severity of the disease. Therapy is often started at a young age and given over many years.

This document is a revision of an earlier note for guidance that came into effect in May 2003.

The revision takes into account the updated international clinical recommendations for asthma. A detailed chapter on the development of medicines for the treatment of asthma in children has also been included, as well as considerations for the development of immunotherapy.

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