CTD Dossier Preparation. Sr.Manager-Regulatory Affairs

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1 CTD Dossier Preparation K. Srikantha Reddy Sr.Manager-Regulatory Affairs Medreich Limited

2 CTD Dossier Preparation CTD (Common Technical Document) contains 5 modules Module 1 Module 2 Module 3 Module 4 Module 5

3 DMF Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support following, Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Export Application.

4 ANDA: An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA contains data which when submitted to FDA's Center For drug Evaluation and Research (CDER), Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

5

6 Module 1 (e.g. EU) Module-1: Administrative Information and Prescribing Information Cover Letter 1.1 Comprehensive Table of Content 1.2 Application Form Product Information SPC s, Labelling and Packaging Mock-Up Specimen Consultation with target patient group SPC s already approved in the Member states Braille

7 Module Information about the Experts 1.5 Specific Requirements for different types of applications 1.6 Environmental Risk Assessment 1.7 Information relating to Orphan Market Exclusivity 1.8 Information relating to Pharmacovigilance 1.9 Information relating to Clinical Trials 1.10 Information relating to Pediatrics 1.11 Response to Queries 1.12 Additional Data

8 Module - 2 Module - 2: CTD Summary Table of Content t (Comprehensive) 2.2 Introduction (general introduction to the pharmaceutical, including its pharmacology class, mode of action, and proposed clinical i l use) 2.3 Quality Overall Summary 2.4 Non-clinical Overview 2.5 Clinical Overview 2.6 Non-clinical Written and Tabulated Summaries 2.7 Clinical summary

9 Module Non-clinical Overview General e Aspects Content and Structural Format 2.5 Clinical Overview Product Development of Content Rationale Overview of Biopharmaceutics Overview of Clinical Pharmacology Overview of Efficacy Overview of Safety Benefits and Risks Conclusions Literature References

10 Module Non-clinical Written and Tabulated Summaries Pharmacology Pharmacokinetics Toxicology Clinical summary Biopharmaceutic Studies and Associated Analytical Methods Clinical Pharmacology Studies Clinical Efficacy Clinical i l Safety Literature References Synopses of Individual Studies

11 Module - 3 Module 3: Quality 3.1 Table of Contents 3.2 Body of Data 3.2.S Drug Substance 3.2.S.1 General Information 3.2.S.1.1 Nomenclature 3.2.S.1.2 Structure 32S S.1.3 General Properties

12 Module S.2 Manufacture 3.2.S.2.1 Manufacturer Details 3.2.S.2.2 Description of Manufacturing Process and Process Controls 32S S.2.3 Control of Materials 3.2.S.2.4 Controls of Critical Steps and Intermediates 32S S.2.5 Process Validation and /or Evaluation 3.2.S.2.6 Manufacturing Process Development 3.2.S.3 Characterisation 3.2.S.3.1 Elucidation of structure and other Characteristics 3.2.S Impurities

13 Module S.4 Control of Drug Substance 3.2.S.4.1 Specification of Drug Substance 3.2.S.4.2 Analytical Procedures 3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.4 Batch Analyses 3.2.S.4.5 Justification of Specification 32S5 3.2.S.5 Reference Standards or Materials 3.2.S.6 Container Closure System 3.2.S.7 Stability 3.2.S.7.1 Stability Summary and Conclusions 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment 3.2.S.7.3 Stability Data

14 Module P Drug Product 3.2.P.1 Description and Composition of the Drug Product 32P2 3.2.P.2 Pharmaceutical Development 3.2.P.2.1 Components of Drug Product 32P P.2.2 Drug Product 3.2.P.2.3 Manufacturing Process Development 3.2.P.2.4 Container Closure System 3.2.P.2.5 Microbiological Attributes 3.2.P.2.6 Compatibility

15 Module P3 3.2.P.3 Manufacture 3.2.P.3.1 Manufacturer 32P P.3.2 Batch Formula 3.2.P.3.3 Description of Manufacturing Process and Process Controls 3.2.P.3.4 Controls of Critical Steps and Intermediates 32P P.3.5 Process Validation and /or Evaluation

16 Module P4 3.2.P.4 Control of Excipients 3.2.P.4.1 Specifications 32P P.4.2 Analytical Procedures 3.2.P.4.3 Validation of Analytical Procedures 3.2.P.4.4 Justification of Specifications 32P P.4.5 Excipients of Human or Animal Origin 3.2.P.4.6 Novel Excipients

17 Module P5 3.2.P.5 Control of Drug Product 3.2.P.5.1 Specification of Drug Product 32P P.5.2 Analytical Procedures 3.2.P.5.3 Validation of Analytical Procedures 3.2.P.5.4 Batch Analyses 3.2.P.5.5 Characterisation of Impurities 3.2.P.5.6 Justification of Specification 3.2.P.6 Reference Standards or Materials 3.2.P.7 Container Closure System

18 Module P.8 Stability 3.2.P.8.1 Stability Summary and Conclusions 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment 32P P.8.3 Stability Data

19 Module A Appendices 3.2.A.1 Facilities and Equipment 3.2.A.2 Adventitious Agents Safety Evaluation 32A3 3.2.A.3 Novel Excipients 3.2.R Regional Information/ Requirements 3.2.R.1 Process Validation and or Evaluation 3.2.R.2 Medical Device 3.2.R.3 Restricted part of DMF 32R4 3.2.R.4 Medicinal i products containing i or using in the manufacturing process materials of animal and / or human origin. 3.3 List of Literature References

20 Module - 4 Module - 4: Non-clinical Study Reports 4.1 Table of contents 4.2 Study Reports Pharmacology Primary Pharmacodynamic Secondary Pharmacodynamic Safety pharmacology Pharmacodynamic drug interactions

21 Module Pharmacokinetics Analytical Methods and validation Reports Absorption Distribution Metabolism Excretion Pharmacokinetic Drug Interactions Other Pharmacokinetic studies

22 Module Toxicology Single-dose toxicity Repeat-dose toxicity Genotoxicity Carcinogenicity Reproductive and developmental toxicity it Local tolerance Other toxicity studies 4.3 Literature References

23 Module - 5 Module - 5: Clinical i l Study Reports 5.1 Table of Contents 5.2 Tabular Listings of All Clinical Studies 5.3 Clinical Study Reports Bioavailability (BA) study Reports Comparative BA and Bioequivalence study reports In-vitro In-vivo Correlation study reports Reports of Bioanalytical and Analytical methods Plasma Protein Binding Study Reports Reports of Hepatic metabolism and Drug Interaction Studies Reports of Studies Using human Biomaterials

24 Module Healthy Subject PK and Initial Tolerability study reports Patient PK and Initial Tolerability study reports Intrinsic Factor PK study reports Extrinsic i Factor PK study reports Population PK study reports Healthy subject PD and PK/PD study reports Patient PD and PK/PD study reports Study reports of controlled clinical studies

25 Module Study reports of Uncontrolled clinical studies Reports of Analyses of data from more than one study Other clinical study reports Reports of Post-Marketing Experience Case report forms and Individual patient listings 5.4 List of Key Literature References

26 ectd (Version 3.2.2) K. Srikantha Reddy Sr. Manager-Regulatory Affairs Medreich Limited

27 ectd ectd electronic Common Technical Document The ectd is the electronic equivalent to the CTD. Regulatory Perspective The ectd is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. Common structure for Modules 2 through 5 Agency specific requirements for Modules 1

28 Technical Perspective ectd Structured set of common folders structure containing PDFs and SAS files (Statistical Analysis Software) on a CD/DVD (Can also be submitted through Agency web portals) The ectd backbone is an XML file (Extensible Markup Language) representing the structure t of the submission, it includes links to files and other metadata such as check sum information. The schema for the XML is very rigid. PDF hyperlinks

29 ectd Granularity of files submitted is small (there are no longer issues of creating large volumes of PDFs). Increased potential for reusing the same submission content across agency submissions. The standard, and many of the modules have been agreed upon by the main worldwide agencies. Once a submission is sent in ectd format all future submissions for the application should be in ectd format. Opportunity to use Part 11 Compliant Electronic Signatures. Use only file formats specified in the guidance

30 ectd Benefits Easy to distribute and review More efficient use of resources, less cost and stress to the organization Highly organized electronic table of contents Searchable Self-validating Integrated document and life-cycle management Cross submission integration Living document New, replace, append & delete

31 How it is different to Paper/Document CTD Overall Table of contents provided in XML (Extensible Markup Language) Utility files to enable technical conformance and viewing i Submission Folders, XML and Utility Files are created automatically ti if an ectd builder is used. Generally high level of granularity in documents Structure is more precise Lifecycle Management of the submission is easier.

32 ectd Implementation - FDA Jan 1, 2008, ectd became CDER s standard for electronic submission. FDA has made it mandatory for all ELECTRONIC submissions i to be in ectd format since However, paper copies are still accepted. Suitable waivers will have to be taken before hand. The number of ANDA submissions to FDA has increased from 72 in the year 2006 to 1550 in 2009

33 ectd Implementation - EU (http://esubmission.emea.europa.eu/) p Requirements on Electronic submissions (Nees (Non-eCTD electronic submission, Version 2.0 March-2010) and ectd) and paper documentation for New Application within MRP, DCP or National procedure Refer CMDh/085/2008/Rev7 October 2010) F 1 t J l 2010 th EU M1 1 4 t b d f ll From 1st July 2010, the EU M1 v1.4 must be used for all ectd submissions for all European procedures,

34 ectd Implementation - MHRA h ti t /M k ti th i ations/index.htm The preferred format for new marketing authorization (MA) applications i is the electronic Common Technical Dossier (ectd) ectd applications must be created according to the current specifications: ectd specification v MHRA will accept applications in PDF-only format (Note that all PDF files included in an ectd (irrespective of the module) should be v1.4, except where there is an agency-specific requirement for a later version (e.g. for an application form)). The Summary of Product Characteristics (SmPC) will need to be prepared using the Word template. Use the MHRA Adobe Application form which is available via the MHRA Portal. This will produce an XML file that MHRA can upload directly into their database.

35 Regulatory Contact information

36 ectd Modules When making an electronic submission, each document should be provided as a separate file. The documents, whether for a marketing application, an investigational application, or a related submission, should be organized based on the five modules in the CTD: Module dl 1i includes ld administrative ii i information if i and prescribing information, Module 2 includes CTD summary documents, Module 3 includes information on quality, Module 4 includes the nonclinical study reports, and Module 5 includes the clinical study reports.

37 ectd Template

38 ectd Screen Shot

39 ectd Screen Shot of Module 2

40 ectd Screen Shot of Module 3

41 ectd Screen Shot of Module 4

42 ectd Screen Shot of Module 5

43 ectd Screen Shot of Module 5

44 ectd Screen Shot of Module 5

45 ectd Management Software ectdxpress Image Solutions imagesolutions.com MasterControl Submissions Gateway - Master Control, com Liquent s EZsubs software solution, Data Farm, Take solution : Lorenz Life Sciences :

46 Thank You SRIKANTH.K

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