2020 marks ICH’s 30th Anniversary. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and the ICH Guidelines are applied by a growing number of regulatory authorities.
The ICH Assembly met on 31 October & 1 November 2023 in Prague, Czech Republic. For more information on the meeting, please see the Press Release.
ICH Assembly Chair with new ICH Observer PPBHK, Hong Kong, China at Prague Meeting, October-November 2023.
Photo L to R: Mr. Frank CHAN Ling-fung (PPBHK, Hong Kong, China); Ms. Lenita Lindström (Assembly Chair - EC, Europe).
The ICH Assembly welcomed the signature of a Memorandum of Understanding (MoU) between ICH and PIC/S (Pharmaceutical Inspection Co-operation Scheme) in October 2023.
For more information, please see the Press Release.
Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Mr. Paul Gustafson (PIC/S); Dr. Theresa Mullin (FDA, United States).
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities... (more)
ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy ... (more)
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines... (more)
Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA)... (more)
