{"id":1748,"date":"2026-10-06T13:02:26","date_gmt":"2026-10-06T13:02:26","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m14\/"},"modified":"2026-10-06T13:02:26","modified_gmt":"2026-10-06T13:02:26","slug":"m14","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m14\/","title":{"rendered":"M14 \u2013 General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2021.<\/p>\n<p>The ICH M14 Guideline reached <em>Step 4<\/em> of the ICH process on 4 September 2025.<\/p>\n<p>The M14 Guideline:<\/p>\n<ul>\n<li>Provides recommendations for generating real-world evidence (RWE) from real-world data (RWD) for regulatory submissions on post-marketing safety, acknowledging regional differences in RWD definitions and allowing supplementary data, including primary data collection where appropriate (see ICH E8);<\/li>\n<li>Provides recommendations with the intent to harmonise expectations for the design, planning, analysis, and reporting of non-interventional safety studies to facilitate regulatory review.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2021. The ICH M14 Guideline reached Step 4 of the ICH process on 4 September 2025. The M14 Guideline provides recommendations for generating real-world evidence\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1748","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1748","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1748\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1748"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1748"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1748"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1748"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}