The Common Technical Document

1
The Common Technical Document

• PRA700

2
Common Technical Document

• The CTD is an ICH Document called M4.
• Organization of the Common Technical Document for
  Registration of Pharmaceuticals for Human use.
• Step 4 (finalized version) issued in November
  2000
• Consists of 4 component guidance's.
• PRIMARY ROLE IS TO INDICATE WHERE AND HOW
  AVAILABLE INFORMATION IS TO BE PRESENTED.

3
New Guidance's from TPD

• Preparation of Drug Submissions in the CTD
  format (final)
• Preparation of Bioequivalence Information for
  Drug Submissions in the CTD format (final)
• Preparation of Quality Information for Drug
  Submissions in the CTD format. (draft)

4
New Templates from TPD

• Quality Overall Summary -Chemical Entities (NDS
  and ANDS) (QOS-CE (NDS) (final)
• QOS-CE Analytical Procedures and Validation
  Information Summaries (final)
• Certified Product Information Document Chemical
  Entities (CPID-CE) (final)
• Certified Product Information Document (Biotech)
  (CPID (Biotech)) in CTD Format (draft)

5
Guidances

• Intended to integrate the CTD within the CDN drug
  regulatory framework by describing regional
  administrative (module 1) and general filing
  requirements.
• Intended to be used in conjunction with CTD
  guidance.
• Only address format issues.
• All documents may be used to develop CTDs.

6
Common Technical Document

• May by used as of July 1, 2001
• MUST be used as of July 1, 2003.
• Applies to
• New Drug Submissions
• Abbreviated New Drug Submissions
• Supplemental New Drug Submissions
• Supplemental Abbreviated New Drug Submissions
• Notifiable Changes

7
Common Technical Document

• CTD format is permitted for subsequent filings
  regardless of the format of the previous
  submission.
• The CTD is intended to last the entire life of
  the product. This idea reflects back to the idea
  that the ultimate goal is to be totally
  electronic.

8
SCOPE OF THE CTD

• As developed by the ICH, the CTD is limited to
  products covered by Q6A and Q6B
• Chemical Entities and Well Characterized Biotech
  Products

9
(No Transcript)
10
(No Transcript)
11
Overall Structure of the CTDModule 1

• Module 1 Administrative Information and
  Prescribing Information
• 1.1 Table of Contents (Module 1 0r 1-5)
• 1.2 Application Forms, Certification, and
  Regulatory Status.
• 1.3 Product labeling
• 1.4 Summaries
• 1.5 Electronic Copies

12
Overall Structure of the CTDModule 2

• Module 2 CTD Summaries
• Overall CTD Table of Contents (Modules 2 5)
• 2.2 Introduction
• 2.3 Quality Overall Summary
• 2.4 Nonclinical Overview
• 2.5 Clinical Overview
• 2.6 Nonclinical Summary
• 2.7 Clinical Summary

13
Overall Structure of the CTDModule 3

• Module 3 Quality
• 3.1 Module 3 Table of Contents
• 3.2 Body of Data
• 3.3 Literature References

14
Overall Structure of the CTDModule 4

• Module 4 Nonclinical Study Reports
• 4.1 Module 4 Table of Contents
• 4.2 Study Reports
• 4.3 Literature References

15
Overall Structure of the CTDModule 5

• Module 5 Clinical Study Reports
• 5.1 module 5 Table of Contents
• 5.2 Tabular listing of Clinical Studies
• 5.3 Clinical Study Reports
• 5.4 Literature References

16
Presentation of Submissions

• PRA 700

17
Paper Submissions

• Serve as the official Central Registry copy until
  TPD is ready to accept submissions in eCTD Format.

18
Binding

• Three Ring binders should be used for all Modules
  
• Colour Coded

19
(No Transcript)
20

• Labeling of binders

21
Table of Contents

• Located in the first volume of each module
• Indicates the exact location where documents may
  be found.
• Volume
• Identification of section, subsection, document

22
Tabs

• Each section, subsection and/or document within a
  module should be separated by a tabbed page with
  an identifier and pagination which corresponds to
  that used in the TOC.

23
Labelling of Tabs

• Should include sufficient details for ease of
  identification. e.g.
• Section or Subsection (e.g., 3.2.A.2)
• Section name (e.g., Adventious Agents Safety
  Evaluation)
• Subsection name (e.g., Materials of Biological
  Origin)
• Name of Document (e.g., Safety Certification)
• Name of attachment or annex to document

24
Pagination

• Following each tab, the document should be
  sequentially paginated starting at page 1.

25
Cross Referencing

• Sufficiently detailed to allow appropriate
  information to be easily located.
• Should correspond to the volume number appearing
  on the binder label and the tab labelling
  details.
• Section, subsection document or attachment and
  pagination.

26
References

• Use Uniform Requirements for Manuscripts
  Submitted to Biomedical Journals, International
  Committee of Medical Journals Editors (ICMJE)
• Same format as Product Monographs

27
Acronyms and Abbreviations

• Define the first time they are used in each
  module.

28
Language

• Either English or French

29
Legibility and Font Size

• 8 x 11 inch paper
• Left margin should be large enough to that
  information is not obscured by binding.
• Font sizes must be large enough to be legible.
• Times New Roman, 12-point font is recommended for
  narrative text.