The International Council for Harmonisation (ICH) met on the 21 \u2013 25 May, in Athens, Greece, for the first time in a hybrid format, with both in-person and virtual participation across the meetings of seven Working Groups, the ICH Management Committee, the MedDRA Management Committee and the ICH Assembly.<\/p>\n
At the meeting, the Assembly reviewed the status of activity of all thirty-one of ICH\u2019s Working Groups; received a report from the MedDRA Management Committee; and was updated on several important recent ICH activities in relation to training and communication.<\/p>\n
Further expansion of ICH Membership and Observership<\/strong><\/p>\n The ICH Assembly welcomed MHRA, UK as a new ICH Member, in addition to ANPP, Algeria as a new ICH Observer, bringing ICH to a total of 20 Members and 35 Observers.<\/p>\n Progress on existing ICH Guidelines and harmonisation activities<\/strong><\/p>\n ICH\u2019s Working Groups have continued to progress their activities, with many groups making significant progress. The following milestones were reached in Athens:<\/p>\n The Assembly also noted significant milestones reached by several Working Groups since the last ICH meeting:<\/p>\n New areas of ICH harmonisation<\/strong><\/p>\n The ICH Assembly endorsed the development of a new ICH Efficacy Guideline on the \u201cInclusion of Pregnant and Breastfeeding Individuals in Clinical Trials\u201d to provide for a globally accepted framework and best practices. The COVID-19 pandemic has illustrated the importance to develop a well-defined harmonised international guideline which will benefit this underserved population, regulators, healthcare providers and the pharmaceutical industry globally.<\/p>\n Training<\/strong><\/p>\n The Assembly was also updated on ICH training related activities, and status of activities to expand work with three ICH Training Associates as part of a 5-year strategic plan to develop online training materials on ICH Guidelines, in addition to offering tailored training. Over the next few years, it is expected that the Training Associates will develop online training materials for the ICH E6(R3), E8(R1), E17, Q3, Q5 and ICH Q8 to Q12 series of Guidelines.<\/p>\n MedDRA<\/strong><\/p>\n The Assembly was updated on the recent release of Swedish and Latvian MedDRA translations in Version 25.0, making MedDRA available in 16 languages in support of users\u2019 language needs. Ongoing work to translate MedDRA into Arabic, Greek, Polish, Maltese, Estonian, Icelandic and Norwegian was also noted. These translations support MedDRA’s steady uptake which is close to 7,500 organisations in almost 130 countries. Collaborative work on targeted mappings with other terminologies continues. In May 2022, the second production of the SNOMED CT \u2013 MedDRA mappings was released. A new Standardised MedDRA Query (SMQ) on Noninfectious myocarditis\/pericarditis has been included in the MedDRA Version 25.0 March release.<\/p>\n Communication<\/strong><\/p>\n The Assembly noted the recent publication of the ICH 30th Anniversary Publication and informative leaflet on the ICH website, providing an overview of ICH\u2019s history and current work, as well as views of different stakeholders on how ICH has contributed to better health and ICH\u2019s future directions in the next 10 years.<\/p>\n The Assembly was additionally informed of a new feature on the ICH website which allows stakeholders to register to be kept up-to-date on new publications and press releases with an email notification.<\/p>\n The next ICH Assembly meeting is planned on the 15 \u2013 16 November 2022 in Incheon, Republic of Korea.<\/p>\n NOTES FOR EDITORS<\/strong><\/p>\n This press release, together with more information on the 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 Twitter @ICH_News<\/a><\/p>\n\n
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