{"id":1752,"date":"2026-10-06T13:02:28","date_gmt":"2026-10-06T13:02:28","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m4s\/"},"modified":"2026-10-06T13:02:28","modified_gmt":"2026-10-06T13:02:28","slug":"m4s","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m4s\/","title":{"rendered":"M4S \u2013 The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety"},"content":{"rendered":"<p><strong>Nonclinical Summaries and Organisation of Module 4<\/strong><\/p>\n<p><em>Re-edited with Numbering and Section Headers changes, September 2002.<\/em><\/p>\n<p>The CTD Safety (M4S) Guideline delineates the structure and format of the nonclinical summaries in Module 2 of the Common Technical Document, and provides the organisation of Module 4, the Nonclinical Study Reports. The Nonclinical Overview should present an integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluation of the pharmaceutical, and generally should not exceed 30 pages. The Nonclinical Written Summaries (100 &#8211; 150 pages) are recommended to provide more extensive summaries and discussion of the nonclinical information on pharmacology, pharmacokinetics and toxicology. Thirty-four templates are provided for the preparation of the Nonclinical Tabulated Summaries, and 31 example tables are provided. Finally, the organisation of the Nonclinical Study Reports in Module 4 is described. Preparation of the nonclinical sections of the Common Technical Document according to the M4S Guideline results in a single Harmonised dossier of the nonclinical information that is acceptable in all ICH regions.<\/p>\n<p><em>Please note that a small typing mistake has been corrected on page 46. Read point 2.6.7.3 Toxicokinetics (instead of 2.7.7.3).<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nonclinical Summaries and Organisation of Module 4. Re-edited with Numbering and Section Headers changes, September 2002. The CTD Safety (M4S) Guideline delineates the structure and format of the nonclinical\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1752","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1752","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\/1752\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1752"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1752"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1752"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1752"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}