European Medicines Agency - Consultaties

Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza Vaccines (CPMP/BWP/214/96) and of the core SmPC/PL for inactivated seasonal influenza vaccines (CMDh/128/2003/Rev5 and CMDh/129/2008/Rev3), Consultation end date 31/10/2013, link

Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome, Consultation end date 15/01/2014, link

Qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer?s disease, Consultation end date 27/08/2013, link

Concept paper on the development of product-specific guidance on demonstration of bioequivalence, Consultation end date 30/09/2013, link

Draft guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis, Consultation end date 31/01/2014, link