{"id":2072,"date":"2023-04-06T13:15:00","date_gmt":"2023-04-06T13:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2023\/04\/06\/ich-m7r2-guideline-reaches-step-4-ich-process\/"},"modified":"2023-04-06T13:15:00","modified_gmt":"2023-04-06T13:15:00","slug":"ich-m7r2-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2023\/04\/06\/ich-m7r2-guideline-reaches-step-4-ich-process\/","title":{"rendered":"The ICH M7(R2) Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH M7(R2) Guideline on the <em>\u201cAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk\u201d<\/em> and the accompanying M7(R2) Addendum <em>\u201cApplication of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes\u201d<\/em> have reached <em>Step 4<\/em> of the ICH Process on 3 April 2023.<\/p>\n<p>In addition, ICH publishes the accompanying <em>\u201cAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk\u201d<\/em> Questions and Answers which were adopted on 24 May 2022 to provide additional clarification, promote convergence and improve harmonisation of the considerations for assessment and control of DNA reactive (mutagenic) impurities found in ICH M7(R2).<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/ich.org\/page\/multidisciplinary-guidelines#7-2\">M7(R2) page<\/a>, including the Guideline and Addendum. In addition, the supporting Q&amp;As can be found on the <a href=\"https:\/\/ich.org\/page\/multidisciplinary-guidelines#7-3\">M7(R2) Q&amp;A page<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M7(R2) Guideline on the \u201cAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk\u201d and the accompanying M7(R2) Addendum have reached Step 4 of the ICH Process on 3 April 2023.<\/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-2072","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\/2072","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=2072"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2072\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2072"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2072"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2072"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}