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


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 which came into effect in May 2003. The revision takes into account the updated international clinical recommendations for asthma. A detailed chapter for the development of medicinal products for the treatment of asthma in children has been included. Some considerations for the development of immunotherapy are also included.


Posted on the EMA website on 1 July 2013