{"id":1990,"date":"2026-09-18T10:45:00","date_gmt":"2026-09-18T10:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2026\/09\/18\/revised-qas-ich-e14-and-ich-s7b-provide-updated-implementation-support\/"},"modified":"2026-09-18T10:45:00","modified_gmt":"2026-09-18T10:45:00","slug":"revised-qas-ich-e14-and-ich-s7b-provide-updated-implementation-support","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2026\/09\/18\/revised-qas-ich-e14-and-ich-s7b-provide-updated-implementation-support\/","title":{"rendered":"Revised Q&#038;As for ICH E14 and ICH S7B Provide Updated Implementation Support"},"content":{"rendered":"<p>ICH has published the combined and updated <strong>ICH E14\/S7B Questions &amp; Answers (R1)<\/strong> to provide clarifications related to the clinical and nonclinical assessment of QT\/QTc prolongation and proarrhythmic risk. The new document represents an updated set of questions and answers that replaces the last combined version published in 2022.<\/p>\n<p>This Q&amp;A document complements the ICH E14 and ICH S7B guidelines with clarifications related to several areas, including electrocardiogram methodology, study design, use of concentration response-modeling, best practices for <em>in vitro<\/em> and <em>in vivo<\/em> non-clinical studies, and others.<\/p>\n<p>ICH Q&amp;As are companion documents, produced as needed to clarify guidelines and respond to practical implementation questions. While they are separate from the guideline text, they are intended to be used together with the harmonised guidelines. ICH Q&amp;As help to harmonise global implementation by regulatory authorities and industry.<\/p>\n<p>The ICH E14 and ICH S7B guidelines and the newly updated ICH E14\/S7B Q&amp;As (R1) support the scientific evaluation of QT\/QTc prolongation and proarrhythmic risk, improving patient protection from cardiac adverse effects of new medicines. All ICH guidelines facilitate the efficient development and regulatory assessment of medicines through globally harmonised standards.<\/p>\n<p>&gt;&gt; Find <strong>ICH E14\/S7B Q&amp;As (R1)<\/strong> <a href=\"https:\/\/ich.org\/page\/efficacy-guidelines#13-3\"><strong>here<\/strong><\/a><\/p>\n<p>&gt;&gt; Find harmonised guideline <strong>ICH E14<\/strong> <a href=\"https:\/\/ich.org\/page\/efficacy-guidelines#13-1\"><strong>here<\/strong><\/a><\/p>\n<p>&gt;&gt; Find harmonised guideline <strong>ICH S7B<\/strong> <a href=\"https:\/\/ich.org\/page\/safety-guidelines#7-2\"><strong>here<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ICH has published the updated ICH E14\/S7B Questions &#038; Answers (R1) to provide clarifications related to the clinical and nonclinical assessment of QT\/QTc prolongation and proarrhythmic risk.<\/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-1990","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\/1990","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=1990"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/1990\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1990"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=1990"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=1990"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}