Volume 23, Issue 2 - Regulatory Writing Basics
An overview of the Common Technical Document (CTD) regulatory dossier
Author: Debbie Jordan
Abstract
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documentation included in an application for the registration of a human pharmaceutical product. The CTD dossier is divided into five main modules: Module 1 – Administrative information and prescribing information; Module 2 – Overviews and summaries of Modules 3–5; Module 3 – Quality (pharmaceutical documentation); Module 4: Non-clinical reports (pharmacology/toxicology); Module 5: Clinical study reports (clinical trials). Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers.
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References
- ICH M4 Guideline: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (R3) [cited 2004 Jan 13]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf
- ICH M8 Guideline: Electronic Common Technical Document [cited 2010 Nov 8]. Available from: http://www.ich.org/products/guidelines/multidisciplinary/multidisciplinary-single/article/electronic-common-technical-document-ectd.html
- Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [updated 2013 Dec]. Available from: http://www.icmje.org/icmje-recommendations.pdf
- ICH M4 Guideline: General Questions & Answers Document (R3) [2004 Jun]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_QAs.pdf
- ICH M4Q Guideline: Quality Overall Summary of Module 2 and Module 3: Quality (R1) [cited 2002 Sep 12]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
- ICH M4Q Guideline: General Questions & Answers Document (R1) [cited 2003 Jul 17]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4_Quality_Questions_Answers_R1.pdf
- ICH M4S Guideline: Nonclinical Overview and Nonclinical Summaries of Module 2 and Module 4: Safety (R2) [cited 2002 Dec 20]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf
- ICH M4S Guideline: General Questions & Answers Document (R4) [cited 2003 Nov 11]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/The_M4_Safety_Questions___Answers__R4_.pdf
- ICH M4E Guideline: Clinical Overview and Clinical Summary of Module 2 and Module 5: Clinical Study Reports (R1) [cited 2002 Sep 12]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf
- ICH M4E Guideline: General Questions & Answers Document (R4) [cited 2004 Jun 10]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/The_M4_Efficacy_Questions___Answers__R4_.pdf
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