{"id":1774,"date":"2026-10-06T13:11:38","date_gmt":"2026-10-06T13:11:38","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/m7-r3\/"},"modified":"2026-10-06T13:11:38","modified_gmt":"2026-10-06T13:11:38","slug":"m7-r3","status":"publish","type":"draft_guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/m7-r3\/","title":{"rendered":"M7(R3) \u2013 Maintenance of the Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities"},"content":{"rendered":"<p>The ICH M7 Guideline was finalised under <em>Step 4<\/em> in June 2014, with a M7(R2) Guideline and Addendum reaching <em>Step 4<\/em> of the ICH process in April 2023 and M7(R2) Q&amp;A reaching <em>Step 4<\/em> in May 2022.<\/p>\n<p><strong>Maintenance Process<\/strong><br \/>A Maintenance process for the M7 Guideline was set up to enable the revision and inclusion of new drug substances and drug products and the assessment of the mutagenic potential of impurities.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M7 Guideline was finalised under Step 4 in June 2014, with a M7(R2) Guideline and Addendum reaching Step 4 of the ICH process in April 2023 and M7(R2) Q&#038;A reaching Step 4 in May 2022. A maintenance process\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1774","draft_guideline","type-draft_guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline\/1774","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/draft_guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline\/1774\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1774"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1774"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1774"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1774"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}