The aim of this guideline is to provide guidance on the clinical development of compounds for the treatment of cystic fibrosis (CF), a systemic chronically debilitating disease, mainly paediatric up to now, with a regularly increasing adult population as life expectancy improves. Full document...

This document outlines the principles for the clinical evaluation of diagnostic agents that are intended for in vivo administration. Such uses may include, but are not limited to, structure delineation, functional assessment including biological and physiological processes, detection or assessment of diseases or pathology as well as prognostic and/or therapeutic management guidance. Full document...

This guideline provides the basis for a fast track authorisation procedure for pandemic influenza vaccines within the EU. The procedure that is explained in detail below involves the submission and approval of a core pandemic dossier during the interpandemic period, which is based on a mock-up vaccine. Full document...

This guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products. Full document...

This guideline acknowledges the constraints put on clinical drug development imposed by the high rate of mutations of HCV and therefore emphasises the importance of taking the risk of selecting for resistant variants into account in the design of clinical studies, including the possible use of adding more than one DAA to SOC. Full Document...