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 (eds) Global Approach in Safety Testing. Molzon J.A. ICH Harmonization for better Health ICH The International Council for Harmonization of Technical Requirements for Pharmaceuticals for (2013) The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health. In: van der Laan J., DeGeorge J. In the biopharmaceutical industry, regulatory harmonization is the process by which technical guidelines are developed to be uniform across participating authorities. View 6. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. –Since 2008, regulators have been invited to the –ICH created the Global Cooperation Group (GCG) in 1999 to promote a better understanding of ICH guidelines and ICH itself. Harmonisation does not mean loss of national sovereignty/autonomy Provides platform for better communication between industry and regulator to … Greater regulatory harmonization and transparency will promote job growth, innovation and better health … Beyond the ICH regions •Recently, the ICH emphasize the global co-operation, extending ICH’s harmonized approach beyond the traditional ICH regions. Source: Health Advances analysis, ICH website, FDA 2017 Overview of ICH, Kuhnert 2011 DIA Global Forum, Brennan 2016 RAPS. Springer, New York, NY ICH.pptx from DEPARTMENT 101 at Kathmandu University. 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.