{"id":1738,"date":"2026-10-06T13:02:23","date_gmt":"2026-10-06T13:02:23","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m7\/"},"modified":"2026-10-06T13:02:23","modified_gmt":"2026-10-06T13:02:23","slug":"m7","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m7\/","title":{"rendered":"M7 \u2013 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk"},"content":{"rendered":"<p>The ICH M7(R2) Guideline reached <em>Step 4 <\/em>of the ICH process on 3 April 2023.<\/p>\n<p>The M7(R2) Guideline is intended to provide guidance for new drug substances and products during their clinical development and subsequent applications for marketing. It also applies to post-approval submissions of marketed products, and to new marketing applications for products with a drug substance that is present in a previously approved product, in both cases only where:<\/p>\n<ul>\n<li>Changes to the drug substance synthesis result in new impurities or increased acceptance criteria for existing impurities;<\/li>\n<li>Changes in the formulation, composition or manufacturing process result in new degradation products or increased acceptance criteria for existing degradation products;<\/li>\n<li>Changes in indication or dosing regimen are made which significantly affect the acceptable cancer risk level.<\/li>\n<\/ul>\n<p>The ICH M7(R2) Addendum describes AIs (Acceptable Intakes) or Permissible Daily Exposures (PDEs) which have been derived for a set of chemicals that are considered to be mutagens and carcinogens and are common in pharmaceutical manufacturing or are useful to illustrate the principles for deriving compound-specific intakes described in ICH M7(R2).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M7(R2) Guideline reached Step 4 of the ICH process on 3 April 2023. The M7(R2) Guideline is intended to provide guidance for new drug substances and products during their clinical development and subsequent\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1738","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1738","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\/1738\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1738"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1738"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1738"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}