{"id":1995,"date":"2026-06-04T18:30:00","date_gmt":"2026-06-04T18:30:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2026\/06\/04\/key-outcomes-biannual-ich-assembly-meeting\/"},"modified":"2026-06-04T18:30:00","modified_gmt":"2026-06-04T18:30:00","slug":"key-outcomes-biannual-ich-assembly-meeting","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2026\/06\/04\/key-outcomes-biannual-ich-assembly-meeting\/","title":{"rendered":"Key Outcomes of Biannual ICH Assembly Meeting"},"content":{"rendered":"<p><em><strong>PRESS RELEASE<\/strong><\/em><\/p>\n<p>The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in person on 2\u20133 June 2026 in Rio de Janeiro, Brazil for its biannual meeting. The ICH Assembly meeting was preceded by meetings of the ICH Management Committee and the MedDRA Steering Committee on 31 May and 1 June. In parallel, 12 ICH Expert Working Groups met for face-to-face working sessions.<\/p>\n<p>The meeting was opened by ICH Assembly Chair Dr. Gabriela Zenh\u00e4usern (Swissmedic, Switzerland) and Vice-Chair Mr. Jeffrey Skene (Health Canada, Canada), with welcome remarks from Dr. Leandro Safatle, Director President of ANVISA, Brazil.<\/p>\n<p><strong>New Observers<\/strong><\/p>\n<p>The ICH Assembly was pleased to approve two Observership applications recommended by the ICH Management Committee since their last meeting in November 2025: <strong>DRAP, Pakistan<\/strong> and <strong>Medsafe, New Zealand<\/strong>. This brings ICH to a total of <a href=\"https:\/\/ich.org\/page\/members-observers\"><strong>25 Members<\/strong> and <strong>43 Observers<\/strong><\/a>.<\/p>\n<p><strong>ICH Strategic Vision &amp; Roadmap<\/strong><\/p>\n<p>The Assembly discussed ICH\u2019s future direction and approved a proposed <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/2026-06\/ICH_Strategic_Vision_2026_0603.pdf\"><strong>Strategic Vision<\/strong><\/a> outlining ICH\u2019s vision, mission and role in advancing public health through harmonised guidelines. The Assembly also received an update on the development of a multi-year Strategic Roadmap for ICH Guidelines. The Strategic Roadmap will include a revised process for selecting new topics for ICH Guideline development.<\/p>\n<p><strong>Guideline Adopted as Final by the Assembly<\/strong> <em>(Step 4 of the ICH harmonisation process)<\/em><\/p>\n<ul>\n<li><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_E6%28R3%29_Annex%202_Guideline_Step%204_2026_0603_0.pdf\"><strong>ICH E6(R3) Annex 2<\/strong><\/a>: Guideline for Good Clinical Practice, Annex 2<\/li>\n<\/ul>\n<p><strong>Progress on ICH Guideline Development<\/strong><\/p>\n<p>The Assembly received an update from the Pharmacopeial Discussion Group on ICH Q4B maintenance activities and received reports from the Working Groups meeting concurrently in Rio de Janeiro, noting good progress across a wide range of <a href=\"https:\/\/ich.org\/page\/ich-guidelines\"><strong>ICH guidelines<\/strong><\/a>, including:<\/p>\n<ul>\n<li><strong>Quality guidelines<\/strong>: ICH Q1 (Stability Testing), ICH Q3E (Extractables and Leachables), ICH Q5E Annex (ATMP comparability) and ICH Q6(R1) (Specifications).<\/li>\n<li><strong>Efficacy guidelines<\/strong>: ICH E21 (Pregnant and Breastfeeding Individuals), ICH E22 (Patient Preference Studies) and ICH E23 (Real-World Evidence).<\/li>\n<li><strong>Safety guidelines<\/strong>: ICH S13 (Oligonucleotide-based therapeutics).<\/li>\n<li><strong>Multidisciplinary guidelines<\/strong>: ICH M4Q(R2) (CTD), ICH M7 Addendum (Nitrosamines), ICH M13 (Bioequivalence) and ICH M18 (Biosimilars).<\/li>\n<\/ul>\n<p><strong>ICH Digital Platform<\/strong><\/p>\n<p>The Assembly was updated on the work of the <a href=\"https:\/\/ich.org\/page\/ich-technology-task-force\"><strong>ICH Technology Task Force<\/strong><\/a>, which was established in 2025 to develop recommendations defining the functional and technical requirements for a digital platform for collaboration to support the harmonised development and consistent implementation of ICH Guidelines. The <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/2026-06\/ICH_TTF_final_report_2026_0603_for_website.pdf\"><strong>Report of the ICH Technology Task Force<\/strong><\/a> was approved for publication on the ICH website.<\/p>\n<p><strong>MedDRA<\/strong><\/p>\n<p>The Assembly was informed about the release of <a href=\"https:\/\/ich.org\/page\/meddra\"><strong>MedDRA<\/strong><\/a> Version 29.0 in 27 languages in March 2026, with the Companion Document (Release 4.0) expected later this year. The Maintenance and Support Services Organisation (MSSO), which maintains and updates MedDRA on behalf of ICH, launched a new Download API in October 2025, providing a more efficient way for users to access MedDRA data files. Training has reached over 16,000 users across 108 countries, with strong engagement in Latin America, where MedDRA use is required by many regulatory authorities. Growth also remains strong in Asia, while expanded outreach includes new initiatives in Africa and the Middle East.<\/p>\n<p><strong>Annual Report<\/strong><\/p>\n<p>The Assembly reviewed and approved the <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/2025_Annual_Report_of_the_ICH_Association_0.pdf\"><strong>2025 Annual Report of the Association<\/strong><\/a> and granted discharge to the ICH Management Committee and the ICH Secretariat for their activities in 2025.<\/p>\n<p><strong>Organisation of Future Meetings<\/strong><\/p>\n<p>The next planned ICH biannual meetings will be held:<\/p>\n<ul>\n<li>14\u201318 November 2026 in Prague, Czech Republic<\/li>\n<li>12\u201316 June 2027 in Madrid, Spain<\/li>\n<\/ul>\n<p><strong>About ICH<\/strong><\/p>\n<p>The <strong>International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)<\/strong> brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical development.<\/p>\n<p>Through expert Working Groups, ICH develops harmonised guidelines to ensure safe, effective, and high-quality medicines worldwide. ICH also develops standards such as MedDRA and supports electronic standards for regulatory information.<\/p>\n<p>Since its creation in 1990, ICH has produced numerous guidelines that are used globally and continues to expand its membership and areas of activity.<\/p>\n<p>For further information, please contact the ICH Secretariat at media@ich.org.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Assembly met in person on 2\u20133 June 2026 in Rio de Janeiro, Brazil for its biannual meeting, preceded by meetings of the ICH Management Committee and the MedDRA Steering Committee.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-1995","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/1995","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=1995"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/1995\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1995"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=1995"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=1995"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}