The Sixth International Conference on Harmonisation (ICH 6) – A Promising Future in Global Pharmaceutical Industry Roy Amitava1,*, Ghosh Amitava1, Datta Supriya1, Das Arindam2, Ganguli Subarna1 1Himalayan Pharmacy Institute, Majhitar, Rangpo, East Sikkim, 737136 2Regional Institute of Pharmaceutical sciences and Technology, Agartala, Tripura *Corresponding Author E-mail: jamitamitava@yahoo.co.in/amitoli@rediffmail.com
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. Top Keywords Harmonisation, Future in Global. Top |