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The guideline details how Module 2 nonclinical overview and nonclinical summaries should be organized, presented, and structured within the CTD framework, including written and tabulated summaries. It specifies section-level content expectations and formatting principles for key subtopics such as general aspects, pharmacology summaries, pharmacokinetics summaries, and supporting tables and figures under the current Step 4 version.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/ich-harmonised-tripartite-guideline-safety-m4sr2-nonclinical-overview-and-nonclinical-summaries-of-module-2-organisation-of-module-4-current-step-4-version/506113/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/ich-harmonised-tripartite-guideline-safety-m4sr2-nonclinical-overview-and-nonclinical-summaries-of-module-2-organisation-of-module-4-current-step-4-version/506113.png","ImageObject",300,407,{"name":92,"@type":93},"Pentious","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-04","2026-10-04",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",14,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What does ICH M4S(R2) cover in the CTD safety section?","Question",{"text":113,"@type":114},"It covers the nonclinical overview and nonclinical summaries required for Module 2, including how written and tabulated summaries should be organized and presented for pharmaceutical registration safety evaluation.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"Which parts of the nonclinical overview and summaries are specified in the table of contents?",{"text":118,"@type":114},"The guideline specifies General Principles, 2.4 Nonclinical Overview (General Aspects and Content/Structural Format), and 2.6 Nonclinical Written and Tabulated Summaries, including pharmacology and pharmacokinetics sub-sections.",{"name":120,"@type":111,"acceptedAnswer":121},"What approval context and version information is provided for M4S(R2)?",{"text":122,"@type":114},"The document states it reached Step 4 of the ICH Process, includes a current Step 4 version dated 20 December 2002, and notes approvals by the ICH Steering Committee for adoption to the three regulatory parties.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},506113,1791240598,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146,"preview_page_count":4},1374404730887,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE  \nICH HARMONISED TRIPARTITE GUIDELINE  \nTHE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE:  \nSAFETY – M4S(R2)  \nNONCLINICAL OVERVIEW AND NONCLINICAL SUMMARIES OF  \nMODULE 2  \nORGANISATION OF MODULE 4  \nCurrent Step 4 version  \ndated 20 December 2002  \nThis Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.  \nM4S(R2) Document History  \n\n| First\u003Cbr>Codification | History | Date | New\u003Cbr>Codification\u003Cbr>November\u003Cbr>2005 |\n| --- | --- | --- | --- |\n\n\n| M4S | Approval by the Steering Committee under Step 2 and release for public consultation. | 20\u003Cbr>July\u003Cbr>2000 | M4S |\n| --- | --- | --- | --- |\n| M4S | Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. | 8\u003Cbr>November\u003Cbr>2000 | M4S |\n| M4S | Approval by the Steering Committee of Numbering and Section Headers changes for consistency directly under Step 4 without further public consultation. | 12\u003Cbr>September\u003Cbr>2002 | M4S(R1) |\n\nCurrent Step 4 version  \n\n| M4S | Approval by the Steering Committee of a minor editorial correction. | 20\u003Cbr>December\u003Cbr>2002 | M4S(R2) |\n| --- | --- | --- | --- |\n\nIn order to facilitate the implementation of the M4S guideline, the ICH Experts have developed a series of Q&As which can be downloaded from the ICH web site: [http://www.ich.org](http://www.ich.org)  \nM4S Questions & Answers History  \n\n| M4S Q&As | Approval by the Steering Committee. | 24\u003Cbr>May\u003Cbr>2001 | M4S Q&As |\n| --- | --- | --- | --- |\n| M4S Q&As | Approval by the Steering Committee of the newly added questions. | 12\u003Cbr>September\u003Cbr>2002 | M4S Q&As\u003Cbr>(R1) |\n| M4S Q&As | Approval by the Steering Committee of the newly added questions. | 6\u003Cbr>February\u003Cbr>2003 | M4S Q&As\u003Cbr>(R2) |\n| M4S Q&As | Approval by the Steering Committee of the newly added questions. | 18\u003Cbr>July\u003Cbr>2003 | M4S Q&As\u003Cbr>(R3) |\n\nCurrent M4S Questions & Answers posted on the web site  \n\n| M4S Q&As | Approval by the Steering Committee of the newly added questions. | 11\u003Cbr>November\u003Cbr>2003 | M4S Q&As\u003Cbr>(R4) |\n| --- | --- | --- | --- |\n\nTHE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE:  \nSAFETY  \nNONCLINICAL OVERVIEW AND NONCLINICAL SUMMARIES OF  \nMODULE 2  \nORGANISATION OF MODULE 4  \nICH Harmonised Tripartite Guideline  \nHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideline is recommended for  \nadoption to the three regulatory parties to ICH  \n(Numbering and Section Headers have been edited for consistency and use in e-CTD as agreed at the Washington DC Meeting, September 11-12, 2002)  \n(This document includes the typographic correction on page 46 : to read point [2.6.7.3](2.6.7.3), agreed by the Steering Committee on 20 December 2002).  \nTABLE OF CONTENTS  \nMODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES .................... 1  \nGeneral Principles of Nonclinical Overview and Summaries............................................ 1  \n2.4 NONCLINICAL OVERVIEW ................................................................................ 1  \nGeneral Aspects .......................................................................................................... 1  \nContent and Structural Format .......................................................................................... 2  \n2.6 NONCLINICAL WRITTEN AND TABULATED SUMMARIES ...................... 3  \nNonclinical Written Summaries .......................................................................................... 3  \nIntroduction.......................................................................","cbCaiqwFaB2iWhV4","https://ap.wps.com/l/cbCaiqwFaB2iWhV4","pdf",1036367,115,"English","# MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES\n## General Principles of Nonclinical Overview and Summaries\n## 2.4 NONCLINICAL OVERVIEW\n## General Aspects\n## Content and Structural Format\n## 2.6 NONCLINICAL WRITTEN AND TABULATED SUMMARIES\n## Nonclinical Written Summaries\n## Introduction\n## General Presentation Issues\n## 2.6.1 Introduction\n## 2.6.2 Pharmacology Written Summary\n## 2.6.2.1 Brief Summary\n## 2.6.2.2 Primary Pharmacodynamics\n## 2.6.2.3 Secondary Pharmacodynamics\n## 2.6.2.4 Safety Pharmacology\n## 2.6.2.5 Pharmacodynamic Drug Interactions\n## 2.6.2.6 Discussion and Conclusions\n## 2.6.2.7 Tables and Figures\n## 2.6.3 Pharmacology Tabulated Summary (see Appendix B)\n## 2.6.4 Pharmacokinetics Written Summary\n## 2.6.4.1 Brief Summary\n## 2.6.4.2 Methods of Analysis\n## 2.6.4.3 Absorption\n## 2.6.4.4 Distribution\n## 2.6.4.5 Metabolism (interspecies comparison)\n## 2.6.4.6 Excretion","[{\"question\":\"What does ICH M4S(R2) cover in the CTD safety section?\",\"answer\":\"It covers the nonclinical overview and nonclinical summaries required for Module 2, including how written and tabulated summaries should be organized and presented for pharmaceutical registration safety evaluation.\"},{\"question\":\"Which parts of the nonclinical overview and summaries are specified in the table of contents?\",\"answer\":\"The guideline specifies General Principles, 2.4 Nonclinical Overview (General Aspects and Content/Structural Format), and 2.6 Nonclinical Written and Tabulated Summaries, including pharmacology and pharmacokinetics sub-sections.\"},{\"question\":\"What approval context and version information is provided for M4S(R2)?\",\"answer\":\"The document states it reached Step 4 of the ICH Process, includes a current Step 4 version dated 20 December 2002, and notes approvals by the ICH Steering Committee for adoption to the three regulatory parties.\"}]","ICH Harmonised Tripartite Guideline - Safety - M4S(R2) - Nonclinical Overview and Nonclinical Summaries of Module 2, Organisation of Module 4 - Current Step 4 version | PDF",1791157611,290]