Presentation on CTD & E-CTD

1. CTD & ECTD
Prepared By : Apoorva Bauskar
Dr D.Y. Patil College of Pharmacy, Akurdi, Pune

2. INTRODUCTION
 There is a joint initiative involving both regulators and
research‐based industry representatives of the European
Union, Japan and the USA in scientific and technical
discussions of the testing procedures required to assess
and ensure the safety, quality and efficacy of medicines.
 The objective is to increase international harmonisation of
technical requirements to ensure that safe, effective, and
high quality medicines are developed and registered in the
most efficient and cost‐effective manner.
 Activities have been undertaken to promote public health,
prevent unnecessary duplication.

3. WHAT IS ICH ?
 "International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use".
 Purpose : achieve greater harmonisation in the
interpretation and application of technical guidelines and
requirements for product registration in order to reduce or
prevent the need to duplicate the testing carried out during
the research and development of new medicines.
 This unique project brings together the participants in the
three regions to discuss scientific and technical aspects of
product registration.

4. CTD
 ‘Common Technical Document’.
 Set of specification for application dossier for the registration
of Medicines and designed to be used across Europe,
Japan and the 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.
 Developed : European Medicines Agency (EMA, Europe),
the USFDA and the Ministry of Health, Labour & Welfare
(Japan).

5.  Agreed : November 2000, in San Diego, USA.
 Purpose : provide a harmonised structure and format for
new product applications.
 The use of the CTD format has become mandatory as from
1 July 2003 in the European Union.
 Focus : provide a common format for the preparation of a
well structured submission according to the modular
framework described in the ICH guidelines of the Common
Technical Document for Registration for Human Use (ICH
Topic M4).
 Indicates where and how available information is to be

6. CTD STRUCTURE

7.  Module 1: Regional Administrative Information.
 Module 2 : Introduction, Quality Overall Summary,
Nonclinical Overview, Clinical Overview, Nonclinical Written
and Tabulated Summaries, Clinical Summary.
 Module 3: Quality.
 Module 4: Nonclinical Study Reports.
 Module 5: Clinical Study Reports

8. MODULE 1
FOR USA FOR EUROPE
 Application form 356h.
 Proposed label.
 Patent
Certification/information.
 Debarment certificate.
 Letter of Authorization/DMF
letter.
 Labeling Text.
 Application Form.
 Summary of product
characteristics.
 Labeling text.
 Information about experts.
 Environmental Risk
Assessment.
 Description of
Pharmacovigilance Team.
 Risk Management Pain.

9. MODULE 2
 Contains 7 sections :
 2.1 CTD TOC (Module 2-5)
 2.2 CTD Introduction
 2.3 Quality Overall Summary
 2.4 Non-clinical Overview
 2.5 Clinical Overview
 2.6 Non-clinical Summary
 2.7 Clinical Summary

12. MODULE 3
 3.1 TOC of Module 3
 3.2 Body of Data
 3.2 S Drug Substance
 3.2 P Drug Product
 3.2 A Appendices
 3.2 R Regional Information
 3.3 Literature References

13. MODULE 4
 4.1 TOC of Module 4
 4.2 Study Reports
 4.2.1 Pharmacology
 4.2.2 Pharmacokinetics
 4.2.3 Toxicology
 4.3 Literature References

14. MODULE 5
 5.1 TOC of Module 5
 5.2 Tabular Listing of Clinical Studies
 5.3 Clinical Study Reports
 5.3.1 Reports of Biopharmaceutical (BA-BE) Studies
 5.3.2 Reports of Pharmacokinetic (Biomaterial) Study
 5.3.3 Reports of Pharmacokinetic (PK) Study
 5.3.4 Reports of Pharmacodynamic Studies
 5.3.5 Reports of Safety & Efficacy Studies
 5.3.6 Reports of Post Marketing Surveiliance
 5.3.7 Case Report Forms & Individual Pattern Listings.
 5.4 Literature References.

15. ECTD
 ‘Electronic Common Technical Document’.
 Electronic Version of CTD.
 Interface and international specification for
the pharmaceutical industry to agency transfer of
regulatory information. The specification is based on
the Common Technical Document (CTD) format.
 Developed : ICH Multidisciplinary Group 2 (ICH M2
EWG).
 Improve the submission and review process.
 Increase accuracy of the submission.
 Decrease total costs.

16. ECTD IMPLEMENTATION
 ICH‐eCTD is an internationally driven standard designed to
reduce cost in the administration, assessment and archiving
of applications for marketing authorisation of medicinal
products for human use, to reduce the use of paper and
streamline the assessment process making the system
more efficient.
 Unlike CTD the eCTD is not mandatory in Europe.
 NCAs are progressively adapting their infrastructure,
processes and legislation to be able to receive and handle
paperless applications for marketing authorisation by 2009.

17. ECTD CHANGES
 XML based eCTD backbone replaces PDF Tables of
Content (index xml file). The purpose of this file is two‐fold :
 Manage meta‐data for the entire submission.
 Constitute a comprehensive table of contents and provide
corresponding navigation aid.
 Increase document granularity in accordance with ICH
eCTD agreements.
 Life Cycle Management :
 Composed at least of an initial submission.
 Incremental updates.
 Only what was changed needs to be re‐submitted.

18. ECTD SPECIFICATION V 3.2
 eCTD is a message specification for the
transfer of files and metadata from industry
to regulatory.
 The eCTD Specification version 3.2
describes many optional folders and file
names.

20. ECTD SUBMISSIONS CHECKLIST
 eCTD Software.
 Software training & support from supplier.
 Compiling & eCTD.
 eCTD hyper linking.
 QC of eCTD.
 Submit eCTD on CD/DVD or Use Electronic Gateway.

21. BENEFITS OF ECTD
 Improved handling and archiving of submissions.
 Better information management.
 Support of Life Cycle Management.
 Immediate Access to complete and up‐to‐date information
 Search functionality for assessors and increased tracking
ability
 Facilitated Facilitated evaluation evaluation and better
visibility visibility of the process process
 Reduced workload and reuse of information for assessment
reports
 Controlled communication with external experts
 Better use of resources
 Simplified business process
 Better communication with industry

22. CTD ECTD
 Paper work.
 Compiled electronically
with volumes, data &
slipsheets & then printed to
paper.
 Paper volume : A4
 Navigation : TOCs &
volumes.
 Cross- References : target
CTD section number.
 Submitted : Binders in
boxes
 Electronic version.
 Compiled electronically
with documents & folders.
 eDocuments : A4 or US
Letter size.
 Navigation : XML Backbone
 Cross-references
hyperlinked to targets.
 Submitted : CDs or DVDs
or by email