{"id":1712,"date":"2026-10-06T12:48:54","date_gmt":"2026-10-06T12:48:54","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2d-r1\/"},"modified":"2026-10-06T12:48:54","modified_gmt":"2026-10-06T12:48:54","slug":"e2d-r1","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/e2d-r1\/","title":{"rendered":"E2D(R1) \u2013 Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2019.<\/p>\n<p>The ICH E2D(R1) Guideline reached <em>Step 4<\/em> of the ICH process on 15 September 2025.<\/p>\n<p>The ICH E2D guideline provides guidance on definitions and standards for post-approval individual case safety reporting, as well as good case management practices. The recommendations captured within the guideline are harmonised to the extent possible given differences in post-market safety reporting requirements among ICH regions. Where applicable, this guideline notes where regional and local requirements may vary and, as such, marketing authorisation holders (MAHs) should refer to the relevant regional or local regulatory authority\u2019s requirements.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2019. The ICH E2D(R1) Guideline reached Step 4 of the ICH process on 15 September 2025. The ICH E2D guideline provides guidance on definitions and standards for\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[9],"guideline_tag":[],"rd_phase":[],"class_list":["post-1712","guideline","type-guideline","status-publish","hentry","guideline_category-efficacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1712","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\/1712\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1712"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1712"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1712"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1712"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}