The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montr\u00e9al, Canada in parallel of meetings of 11 Working Groups and 1 Discussion Group, and preceded by meetings of the ICH Management Committee (MC) and the MedDRA MC.<\/p>\n
The ICH continues to expand and welcomed with great pleasure CPPS, Uzbekistan; DIGEMID, Peru and Thai FDA, Thailand as new ICH Observers, bringing ICH to a total of 23 Members and 38 Observers.<\/p>\n
Progress on ICH Guideline Development and Important Revisions<\/strong><\/p>\n The Assembly was updated on the MC approval of the Concept Paper for the new ICH S13 Guideline on \u201cNonclinical Safety Studies for Oligonucleotide-based Therapeutics\u201d.<\/em> In addition to receiving reports on progress made at ICH Working Group meetings in Montr\u00e9al, the Assembly also noted significant milestones reached by several Working Groups since the last ICH meeting, which included awaited important updates to some older ICH Guidelines, as well as some new ICH Guidelines:<\/p>\n Monitoring ICH Guideline implementation<\/strong><\/p>\n With monitoring the progress of international harmonisation and coordinating efforts in this regard being an important ICH focus, the Assembly welcomed ICH\u2019s publication in October 2024 on the ICH website of the results of the recent survey conducted in 2024, building on the previous 2019 and 2021 assessments. The main objective of this survey was to monitor progress of international harmonisation, identify regulatory training and capacity building needs, assist the ICH MC in determining whether the Regulatory Members would meet the eligibility criteria for the June 2024 ICH MC elections, and to allow participating Observers interested in future ICH Membership to reference the survey findings to confirm their eligibility.<\/p>\n MedDRA<\/strong><\/p>\n MedDRA Management Committee Vice-Chair election was held during the meeting which saw the appointment of Dr. Craig Simon, Health Canada, Canada to serve for a two-year term.<\/p>\n With the recent release of MedDRA Version 27.1, MedDRA is now available in 24 languages, including the newly added Croatian, Lithuanian, and Icelandic. The MedDRA Management Committee is also pleased to announce the publication of the MedDRA Points to Consider Companion Document Version 3.0, which features a new section on Manufacturing and Quality System Issues. Collaboration with international organizations is ongoing, focusing on targeted mappings with MedDRA to enhance the availability of MedDRA-coded data for analysis, interoperability, supporting patient safety efforts and promoting public health.<\/p>\n Training<\/strong><\/p>\n The Assembly was updated on ICH training related activities, including the recent publication on the ICH website of ICH E8(R1) \u201cGeneral Considerations for Clinical Studies\u201d Introductory Training Video developed by the ICH Training Associate, as well as the updated training materials on ICH Q8\/Q9\/Q10 Guidelines developed by the Q9(R1) Implementation Working Group.<\/p>\n Communication<\/strong><\/p>\n A most welcome news has been shared with the Assembly during the meeting as the ICH has been awarded by DIA Europe the 2025 DIA Regional Inspire Award for Outstanding Contribution to Global Health for its significant and innovative contribution to advancing global health.<\/p>\n The next ICH Assembly meeting is planned on 13 and 14 May 2025 in Madrid, Spain.<\/p>\n NOTES FOR EDITORS<\/strong><\/p>\n This press release, together with more information on the ICH Guidelines mentioned above and the work of ICH, can be found on its website: www.ich.org<\/a><\/p>\n For further information, please contact the ICH Secretariat at pressrelease@ich.org<\/a><\/p>\n Follow ICH on X (formerly Twitter) @ICH_News<\/a><\/p>\n\n