CTD( Common technical Documents) For B.Pharmacy)

CTD for B. pharmacy And
M. pharmacy

1. K.E SOCIETY Rajarambapu College of Pharmacy Kasegaon Common Technical Documents (CTD) Presented by – Ankita Avinash Gadekar . 1 st Year M.pharm ( Pharmcutics ) 1 Common Technical Document

2. 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 2 Common Technical Document

3. CTD It is a Application Format. CTD is a Joint effort of 3 Regulatory Agencies 1.European Medicines Agency (Europe) 2.Food and Drug Administration (FDA, USA) and 3.Ministry of Health, Labour and Welfare(MHLW,Japan) CTD is a set of specifications for a dossier for the registration of medicines (TGA) CTD is an internationally agreed “well Structured common format” for the organization of the technical requirements that is to be submitted to the regulatory authority as an application for the registration of pharmacuticals for human use in all three ICH regions. (USA, Europe, and Japan). 3 Common Technical Document

4. Evolution of CTD 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. In India 2009 – CDSCO adopt CTD format for technical requirements for registration of biological products. October 28,2010 – CDSCo gives guidelines for feedback purpose for industry on preparation of CTD for Import/manufacture and marketing approval of new drug for human use and ask for Comments and suggestion within 60 days. 4 Common Technical Document

5. Why CTD ? 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 and there by ensure faster availability of new medicines. 5 Common Technical Document

6. CTD Triangle 6 Common Technical Document

7. Modules of CTD CTD is Divided into five modules. Administrative and prescribing Information Overview and Summary of modules 3 to 5. Quality (Pharmacutical Documentation) Safety(Toxicology Studies) Efficacy(Clinical Studies) 7 Common Technical Document

8. Module1 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 8 Common Technical Document

9. Module 2- CTD Summaries Module No Contents 2.1 Table of content 2.2 Introduction 2.3 Quality overall summaries 2.4 Non-clinical Overview 2.5 clinical Overview 2.6 Nonclinical Summary 2.7 Clinical Summary 9 Common Technical Document 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. It is consist of 7 sub-modules.

10. 2.3 Quality Overall Summaries The Quality Overall Summary (QOS) is an outline of data presented in module 3. 2.3.S 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 10 Common Technical Document

11. 2.5 Clinical Overview 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 of the clinical Trial. Common Technical Document 11

12. Module 3 - Quality It describes the format and organization of the Chemical , Pharmaceutical and Biological data relevant to the application. It is Contains of 3 sub-modules. Common Technical Document 12 Module Content 3.1 Table of content 3.2 Body of data 3.3 Literature references

13. 3.2 Body of Data 3.2.S Drug Substance(s) 3.2.S.1 General Information (name , Manufacturer) 3.2.S.2 Manufacture of drug Substance (name , Manufacturer) 3.2.S.3 Quality of Drug Substance 3.2.S.4 Stability of Drug Substance 3.2.P Drug Product 3.2.P.4 Control of Excipients 3.2.P.5 Control of Drug Product Common Technical Document 13

14. 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 . Common Technical Document 14 Module Content 4.1 Table of Content 4.2 Study report 4.3 Literature references

15. Module 5 – Clinical study Report It is describes the format and organisation of the clinical data relevant to the application. It is Consist of 4 sub – modules. Common Technical Document 15 Module Content 5.1 Table of Content 5.2 Tabular listing of all clinical study 5.3 Clinical study report 5.4 Literature references

16. Common Technical Document 16 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.

17. Common Technical Document 17 Advantages of CTD To Save time and resources To Facilitate regulatory review and communications. Appropriate format for the data. Easy to understand and evaluation of data. Disadvantages of CTD No detailed information about Content of Dossier. Still not identical for all regions (different regional requirements.

18. Common Technical Document 18 Comparing CTD and eCTD CTD eCTD 1.It is paper base Format 1.It is Digital Format 2.CTD is submitted in Hard Copy. 2.eCTD is submitted electronically. 3.CTD requires manual navigation through physical documents. 3.eCTd allow for electronic navigation through the document. 4.CTD can only be accessed by physically handling the document. 4.eCTD can be accessed remotely through electronic means. 5.CTD not allows for faster and more efficient review by regulatory agencies as compared to eCTD . 5. eCTD allows for faster and more efficient review by regulatory agencies.

19. Common Technical Document 19 Conclusion 1.In conclusion, the Common Technical Document (CTD) is a standardized format for submitting regulatory information for pharmaceuticals, biologics, and medical devices to regulatory agencies. 2.The 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. 3.The eCTD also allows for faster and more efficient review by regulatory agencies. Overall, the adoption of eCTD has improved the regulatory process for pharmaceuticals, biologics, and medical devices.

20. References Textbook of Pharmacutical Regulatory Science, Sachin. D . Shinde, Umesh Mahajan, Pee vee Publication. Drug Regulatory Affairs by, Swapnil Fernandes Common Technical Document 20

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