EMEA: Draft guideline on medicinal products for the treatment of insomnia
The present document should be considered as general guidance on the development for medicinal products for the treatment of acute and chronic forms of insomnia. Its main focus is on primary insomnia, however, some issues on secondary or comorbid insomnia will be mentioned as well. This document should be read in conjunction with other relevant EMEA and ICH guidelines.
Źródło wiadomośći: http://www.emea.europa.eu/pdfs/human/ewp/1627409en.pdf