{"id":1753,"date":"2026-10-06T13:02:28","date_gmt":"2026-10-06T13:02:28","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m4e\/"},"modified":"2026-10-06T13:02:28","modified_gmt":"2026-10-06T13:02:28","slug":"m4e","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m4e\/","title":{"rendered":"M4E \u2013 The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy"},"content":{"rendered":"<p><strong>Module 2: Clinical Overview and Clinical Summary<\/strong><\/p>\n<p><strong>Module 5: Clinical Study Reports. The clinical section of the Application.<\/strong><\/p>\n<p><em>Re-edited with Numbering and Section Headers changes, September 2002.<\/em><\/p>\n<p>CTD Efficacy (M4E) describes the structure and format of the clinical data in an application, including summaries and detailed study reports. There are two high level clinical summaries in Module 2 of the CTD: the Clinical Overview, a short document that provides a critical assessment of the clinical data; and the Clinical Summary, a longer document that focuses on data summarisation and integration. Clinical Study Reports and raw data (where applicable) are included in Module 5 of the CTD.<\/p>\n<p>The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH, was approved by the Assembly under Step 4 of the ICH Process at the Lisbon meeting in June 2016. The M4E(R2) Guideline includes greater specificity on the format and structure of benefit-risk information, harmonising the presentation of this information in regulatory submissions. The document proposes a review and revision in some parts of the Section 2.5 Clinical Overview of the Module 2 of the Common Technical Document (CTD) (Section 2.5.1 and 2.5.6) to ensure the guideline is both Harmonised and sensible in its entirety.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Module 2: Clinical Overview and Clinical Summary. Module 5: Clinical Study Reports, the clinical section of the Application. Re-edited with Numbering and Section Headers changes, September 2002. CTD Efficacy (M4E)\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1753","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1753","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\/1753\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1753"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1753"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1753"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1753"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}