The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. Since its announcement of organisational changes in October 2015, ICH has grown as an organisation and now includes 23 Members and 35 Observers.
With ICH commemorating its 30th Anniversary in 2020, ICH is pleased to release a video in which ICH Members and Observers look back at ICH’s evolution since its inception in 1990, reflect on the positive impact of ICH for public health and share considerations on future directions.
The ICH Assembly met on 4 & 5 June 2024 in Fukuoka, Japan. For more information on the meeting, please see the Press Release.
ICH Assembly Chair and Vice-Chair with new ICH Member ANMAT, Argentina at Fukuoka Meeting, June 2024.
Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Ms. Andrea Ricchiuti (ANMAT, Argentina); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)
ICH Assembly Chair and Vice-Chair with new ICH Member JFDA, Jordan at Fukuoka Meeting, June 2024.
Photo L to R: Ms. Lenita Lindström (Assembly Chair - EC, Europe); Ms. Suna Habahbeh (JFDA, Jordan); Dr. Gabriela Zenhäusen (Assembly Vice-Chair - Swissmedic, Switzerland)
The MedDRA MC met in Fukuoka, Japan with the Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO).
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).
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.
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)
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