For all products administered via the ELPENHALER® device, an extensive clinical development program is performed, which includes Phase I, III and IV clinical trials.
The clinical development of each product (Phase I and III clinical trials) is based on the current directives of the European Medicines Agency (EMA- CPMP).
All clinical trials performed for each product, and irrespective of their outcome, are submitted to the Pharmaceutical Authorities of each country where registration is requested.
After the registration of the product, and as requested by international legislation, Phase IV clinical trials are performed so as to continuously evaluate safety and efficacy of the product in the general population.