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 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.