Will Discuss About- What is CTD? Evolution of CTD Why CTD? CTD Triangle Modules of CTD Advantages and Disadvantages of CTD Comparing CTD and eCTD Conclusion References Common Technical DocumentCTD eek, ¢ Itis a Application Format. * CTD isa Joint effort of 3 Regulatory Agencies [Link] Medicines Agency (Europe) [Link] and Drug Administration (FDA, USA) and [Link] of Health, Labour and Welfare(MHLW,Japan) ¢ CTD isa set of specifications for a dossier for the registration of medicines (TGA) CTD is an internationally agreed “well Structured common format” the organization of the technical requirements that is to be bmitted to the regulatory authority as an application for the tration of pharmacuticals for human use in all three IC!Evolution of CTD fit In ICH region 1995- Concept of CTD proposed by Industry. November 2000 — ICH CTD guideline finalized. September 2002- Guideline re-edited with Numbering and section Header Changes. July 2003 — Voluntary submission phase in three ICH Region. 1 July 2003 — Mandatory Requirement in three ICH Regions. n India * 2009 —CDSCO adopt CTD format for technical requirements for registration of biological products. ctober 28,2010 - CDSCo gives guidelines for feedback pur dustry on preparation of CTD for Import/manufacture agd: eting approval of new drug for human use and ask fo | suggestion within 60 days. Common Technical DocumentWhy CTD ? ? Hi The primary objective of the ICH is to avoid duplicative animal and human testing and to reach a common understanding of the technical requirements to support the registration process in the three ICH region. Maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health. With the development of the CTD, the ICH hopes to accomplish many of its objectives. Reduce the time and resources used to compile application. It will ease the preparation of electronic submission. To facilitate simultaneous submission in three regions. To facilitate easier exchange of regulatory information ai by ensure faster availability of new medicines.CTD Triangle The CTD Triangle Noncinieat ‘Summary Moncanicat ‘Quality study Reports] Module3 |Module 4 Common Technical Documentiit Modules of CTD * CTD is Divided into five modules. 1) Administrative and prescribing Information 2) Overview and Summary of modules 3 to 5. 3) Quality (Pharmacutical Documentation) 4) Safety(Toxicology Studies) 5) Efficacy(Clinical Studies) Common Teehnical Document 7 = one — ee eeModulel ii Administrative and prescribing Information * Module 1 is for administrative information and prescribing information and should contain documents that are specific to each region. ¢ Administrative Information > Brief introduction about the applicant company > Legal and critical Documents such as copy of clinical Trial/BE., No objection letters issued by CDSCO, Batch release certificate issued by national regulatory Authorities * General information on Drug Product * Regulatory Status in Other Countries ¢ Information regarding involvement of experts,if any * Samples of drug materials Omavon Technical Document fee “ AnataModule 2- CTD Summaries *Module 2 summarises the information that will be provided in the quality (module 3), nonclinical (module 4) and clinical (module 5) modules of the dossier. The documents for Modules 3, 4, 5 include a section on the information that must be provided in module 2. elt is consist of 7 sub-modules. ea Contents 2.1 Table of content [Link] Introduction 2.3 Quality overall summaries 2.4 Non-clinical Overview 25 clinical Overview 2.6 Nonclinical Summary 27 Clinical Summary ‘Common Technical Documenter acitgt 2.3 Quality Overall Summaries The Quality Overall Summary (QOS) is an outline of data presented in module 3. 2.3.8 Summary of Drug Substance 2.3.P Summary of Drug Product 2.4 Non — Clinical Overview 2.4.1 Introduction and GLP Statements 2.4.2 — Overview of the Non clinical Testing Strategy 2.4.3 — Pharmacology 2.4.4 — Toxicology 2.4.5 — Conclusions 2.4.6 — List of Literature References Common Technica! Document ir2.5 Clinical Overview paint * Overview of analysis of the clinical data . * Provide a brief overview of the Clinical findings. * Analyse the benefits and risks of the medicinal product in its intended use. 2.6 Non — Clinical Summaries ¢ Summary of Pharmacokinetic, Pharmacological and toxicology studies — In — vivo/In-vitro, Species, route and duration. * Appropriate age and gender related effects. 2.7 Clinical Summaries * This section is intended to provide a detailed information clinical Trial. ‘Common Technical Document uModule 3 - Quality iin * It describes the format and organization of the Chemical , Pharmaceutical and Biological data relevant to the application. ¢ It is Contains of 3 sub-modules. 3.1 Table of content 3.2 Body of data 3.3 Literature references Common Ted R ’itt 3.2 Body of Data r + 3.2.S Drug Substance(s) Y [Link] General Information (name , Manufacturer) v [Link] Manufacture of drug Substance (name , Manufacturer) ¥ [Link] Quality of Drug Substance v [Link] Stability of Drug Substance + 3.2.P Drug Product v 3.2.P.4 Control of Excipients Y 3.2.P.5 Control of Drug ProductModule 4 — Non Clinical study Report * It is describe the format and organisation of the nonclinical (pharmaco-toxicological) data relevant to the application. * It contain 3 sub- modules . Module Content Al Table of Content 42 Study report 43 Literature referencesModule 5 — Clinical study Report * Itis describes the format and organisation of the clinical data relevant to the application. * It is Consist of 4 sub — modules. FLT Ce 5.1 Table of Content 52 Tabular listing of all clinical study 5.3 Clinical study report = 5.4 Literature references a Common Technical Document 15it 5.3 Clinical Study reports 5.3.1 Reports of biopharmacutical studies 5.3.2 Reports of studies pertinent to Pharmacokinetics using human biomaterials. 5.3.3 Reports of human pharmacokinetic (PK) studies. 5.3.4 Reports of human pharmacodynamic (PD) studies. 5.3.5 Reports of efficacy and safety studies. 5.3.6 Reports of Post-marketing experience 5.3.7 Case report forms and individual patient listings. Common Techaieal Document 6= Advantages of CTD ii 1. To Save time and resources 2. To Facilitate regulatory review and communications. 3. Appropriate format for the data. 4. . Easy to understand and evaluation of data. = Disadvantages of CTD 1. No detailed information about Content of Dossier. 2. Still not identical for all regions (different regional requirements.Conclusion [Link] conclusion, the Common Technical Document (CTD) is a standardized format for submitting regulatory information for pharmaceuticals, biologics, and medical devices to regulatory agencies. [Link] electronic Common Technical Document (eCTD) is a digital version of the CTD that is submitted electronically. While the CTD is a paper-based format that requires manual navigation and physical storage, the eCTD is a digital format that allows for electronic navigation, remote accessibility, and digital storage. [Link] eCTD also allows for faster and more efficient review by regulatory agencies. Overall, the adoption of eCTD has improved the regulatory process for pharmaceuticals, biologic$ and medical devices.i References * Textbook of Pharmacutical Regulatory Science, Sachin. D . Shinde, Umesh Mahajan, Pee vee Publication. * Drug Regulatory Affairs by, Swapnil Fernandes“Guidance for Industry on Preparation of Common Technical Document for tmport / Manufacture And Marketing Approval Of New Drugs For Human Use (New Drug Application - NDA)”. Available at [Link] “Guideline M4: The Common Technical Document”. Available at [Link] “ICH Harmonised Tripartite Guideline: Organisation Of The Common Technical Document For The Registration Of Pharmaceuticals For Human Use M4”. Available at [Link]