{"id":2106,"date":"2021-10-06T12:15:00","date_gmt":"2021-10-06T12:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2021\/10\/06\/ich-m7r2-draft-guideline-and-addendum-reaches-step-2-ich-process\/"},"modified":"2021-10-06T12:15:00","modified_gmt":"2021-10-06T12:15:00","slug":"ich-m7r2-draft-guideline-and-addendum-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2021\/10\/06\/ich-m7r2-draft-guideline-and-addendum-reaches-step-2-ich-process\/","title":{"rendered":"The ICH M7(R2) Draft Guideline and Addendum Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached <em>Step 2<\/em> of the ICH process on 6 October 2021 and now enters the <a href=\"https:\/\/www.ich.org\/page\/public-consultations\">public consultation<\/a> period.<\/p>\n<p>The ICH M7 (R2) Addendum provides useful information regarding the acceptable limits of known mutagenic impurities\/carcinogenic and supporting monographs. 7 new compounds have been added in this revision: Acetaldehyde, Dibromoethane, Epichlorohydrin, Ethyl Bromide, Formaldehyde, Styrene, and Vinyl Acetate.<\/p>\n<p>Additionally, a <em>Step 2<\/em> Informational Presentation has also been developed by the Maintenance Expert Working Group.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#7-2\">ICH M7(R2) webpage<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH process on 6 October 2021 and now enters the public consultation period.<\/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-2106","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\/2106","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=2106"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2106\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}