{"id":1751,"date":"2026-10-06T13:02:27","date_gmt":"2026-10-06T13:02:27","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m4q\/"},"modified":"2026-10-06T13:02:27","modified_gmt":"2026-10-06T13:02:27","slug":"m4q","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m4q\/","title":{"rendered":"M4Q \u2013 The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality"},"content":{"rendered":"<p><strong>Module 2: Quality Overall Summary (QOS)<\/strong><\/p>\n<p><strong>Module 3: Quality<\/strong><\/p>\n<p><strong>The section of the application covering chemical and pharmaceutical data including data for biological\/ biotechnological products.<\/strong><\/p>\n<p><em>Re-edited with Numbering and Section Headers changes, September 2002.<\/em><\/p>\n<p>The Quality section of the Common Technical Document (M4Q) provides a Harmonised structure and format for presenting CMC (Chemistry, Manufacturing and Controls) information in a registration dossier. The table of contents includes sections on Drug Substance and Drug Product. A new section on Pharmaceutical Development has been included to replace the Development Pharmaceutics Report (currently a part of the EU submission requirements). Also, a new CMC summary document, the Quality Overall Summary, has been developed.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Module 2: Quality Overall Summary (QOS). Module 3: Quality. The section of the application covering chemical and pharmaceutical data including data for biological\/biotechnological products. Re-edited with Numbering\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1751","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1751","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\/1751\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1751"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1751"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1751"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1751"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}