The Common Technical Document - PowerPoint PPT Presentation

1 / 29
About This Presentation
Title:

The Common Technical Document

Description:

Each section, subsection and/or document within a module should be separated by ... Acronyms and Abbreviations. Define the first time they are used in each module. ... – PowerPoint PPT presentation

Number of Views:1360
Avg rating:3.0/5.0
Slides: 30
Provided by: doreencl
Category:

less

Transcript and Presenter's Notes

Title: 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.
Write a Comment
User Comments (0)
About PowerShow.com