{"id":2016,"date":"2025-09-12T13:45:00","date_gmt":"2025-09-12T13:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2025\/09\/12\/ich-m14-guideline-reaches-step-4-ich-process\/"},"modified":"2025-09-12T13:45:00","modified_gmt":"2025-09-12T13:45:00","slug":"ich-m14-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2025\/09\/12\/ich-m14-guideline-reaches-step-4-ich-process\/","title":{"rendered":"The ICH M14 Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH M14 Guideline on <em>\u201cGeneral Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines\u201d<\/em> has reached <em>Step 4<\/em> of the ICH Process on 04 September 2025 and has now entered the implementation phase at <em>Step 5<\/em> of the ICH Process. The Guideline provides internationally harmonised recommendations for planning, designing, analysing and reporting non-interventional pharmacoepidemiological studies that generate real-world evidence for post-marketing safety submissions.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#14-1\">M14 page<\/a>, including the Guideline and a <em>Step 4<\/em> Introductory Training Presentation available for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M14 Guideline on \u201cGeneral Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines\u201d has reached Step 4 of the ICH Process on 4 September 2025 and has now entered the implementation phase.<\/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-2016","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\/2016","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=2016"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2016\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}