ABSTRACT:
With a view to determine future challenges for the ICH process in the ever-growing Pharmaceutical environment, the Sixth International Conference on Harmonisation (ICH) motivated its focus on areas such as new technologies in the discovery of innovative drugs, opportunities and new challenges for regulatory harmonisation, Pharmacovigilance and global cooperation with regulatory harmonisation initiatives outside the ICH regions. The practical implementation of the Common Technical Document (CTD)-the common format for license application in the three ICH regions - was also an important focus of the ICH6 Conference. Three satellite sessions took place before the plenary Conference: "Partnerships in Harmonisation", "Gene Therapy" and "MedDRA Users' Group". The session on Partnerships in Harmonisation reflected the ICH commitment in establishing collaborative efforts through expanded Global Cooperation Group (GCG) activities with non-ICH Harmonisation initiatives.