ICH.pptx from DEPARTMENT 101 at Kathmandu University. –ICH created the Global Cooperation Group (GCG) in 1999 to promote a better understanding of ICH guidelines and ICH itself. In: van der Laan J., DeGeorge J. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. Harmonisation does not mean loss of national sovereignty/autonomy Provides platform for better communication between industry and regulator to … Springer, New York, NY Beyond the ICH regions •Recently, the ICH emphasize the global co-operation, extending ICH’s harmonized approach beyond the traditional ICH regions. –Since 2008, regulators have been invited to the (2013) The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health. Molzon J.A. View 6. Regional Harmonisation Initiatives (RHIs) APEC ASEAN GSC PANORH SADC International Pharmaceutical Industry Organisation APIC International Organisation regulated or affected by ICH Guideline(s) Bill & Melinda Gates Foundation CIOMS EDOM IPEC USP harmonisation for better health Key pillars of the new regulatory landscape are global bodies, such as the World Health Organization (WHO) and the International Council for Harmonization (ICH), which work to achieve global scientific consensus in developing regulatory guidelines. In the biopharmaceutical industry, regulatory harmonization is the process by which technical guidelines are developed to be uniform across participating authorities. (eds) Global Approach in Safety Testing. Greater regulatory harmonization and transparency will promote job growth, innovation and better health … Source: Health Advances analysis, ICH website, FDA 2017 Overview of ICH, Kuhnert 2011 DIA Global Forum, Brennan 2016 RAPS. ICH Harmonization for better Health ICH The International Council for Harmonization of Technical Requirements for Pharmaceuticals for