CTD & eCTD

CTD
eCTD
organization of CTD & eCTD
CTD triangle
Module 1 to 5

1. Presented By:- Machhi Dhruvi Anilkumar 1st Sem. M.Pharm . Department of Pharmaceutical Quality Assurance Smt. B. N. B. Swaminarayan Pharmacy College, Salvav-vapi Topic:- CTD (Common Technical Document) & eCTD (Electronic Common Technical Document) Subject Name:- Quality Control & Quality Assurance Subject Code:- MQA10 3 T 1

2. Common Technical Document ( CTD ) The common technical document (CTD) is a set of specification for application dossier for the registration of medicines & designed to be used across Europe, Japan & United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. CTD is maintained by ICH of technical requirement for registration of pharmaceutical for human use. 1/3/2022 Dhruvi Machhi Smt.BNB.SPC,Salvav-Vapi 2

3. Electronic common technical document ( eCTD ) Electronic version of CTD is called eCTD. After decades of using paper, the goal is the electronic transfer of drug application & their review across submission formats, procedures & reasons came in Electronic Common Technical Document (ECTD). The eCTD is an interface & international specification for the pharmaceutical industry to transfer regulatory information. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory authority. 1/3/2022 Dhruvi Machhi Smt.BNB.SPC,Salvav-Vapi 3

4. Organization of CTD and eCTD The Common Technical Document is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, & 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities

5. CTD Triangle

6. Module 1-Administrative information and prescribing information The name of the folder for module 1 should be m1. This module contains administrative information that is unique for each region. Regional guidance will provide the specific instructions on how to provide the administrative formats & detailed prescribing information.

7. Module 2-Summaries The name of the folder for module 2 should be m2. This module contains overall summaries of quality, non-clinical & clinical. The files in this module should be provided as PDF text with exception of a few embedded images, when needed. It starts with a general introduction to the drug, including its pharmacological class, mode of action, & proposed clinical use.

8. Module 3-Quality The name of the folder for module 3 should be M3. This module contains Quality aspects of the intended drug or medicinal product. Module 3 presents the chemistry, manufacturing,& controls reports for the product. Full details of what should be included in Module 3 are provided in the ICH M4Q guideline.

9. Module 4 - nonclinical study reports The name of the folder for module 4 should be m4. This module contains details of nonclinical studies. The structure and content of Module 4 is specified in the ICH M4S guidelines

10. Module 5-Clinical study reports The name of the folder for module 5 should be m5. This module contains details of clinical studies. The structure and content of Module 5 is specified in the ICH M4E guidelines,9 which provided a specific placement of clinical study reports & related information to simplify preparation & review & to ensure completeness.

11. References Jordan, Debbie. "An overview of the Common Technical Document (CTD) regulatory dossier."  Medical Writing  23.2 (2014): 101-105.

12. Thank you