COMMON TECHNICAL DOCUMENT , its granularities, benefits, advantages, shortcomings.

1. Common Technical Document
(CTD)
BINDU KSHTRIYA

2. CONTENT
• What is CTD?
• Why CTD?
• Preparing and organizing the CTD
• Guidance for industry
• What is the current status of CTD?
• ICH – Status of harmonized initiatives
• ICH – eCTD
• Implementations within the three ICH regions
• Conclusion
• Advantages of CTD
• Not included in CTD
• Limitations
• Benefits
• Questions
• References

3. What is CTD?
✓ Internationally accepted Application format
✓ CTD is an internationally agreed “well structured
common format” for the organization of the technical
requirements that is to be submitted to the regulatory
authority as an application for the registration of
pharmaceuticals for human use in all three ICH regions
(U.S.A., Europe and Japan).

4. Why CTD?
✓ To provide a harmonized common format/template for
the submission of technical requirement to the
regulatory authorities (FDA) that is acceptable in all 3
ICH regions
✓ Reduce the time and resources used to compile
applications
✓ It will ease the preparation of electronic submissions.

5. š To facilitate simultaneous submission in
three regions.
š To facilitate exchange of regulatory
information.
š Faster availability of new medicines

6. Preparing & Organization of CTD
It is organized into:-
• Module 2: CTD summaries
• Module 3: Quality
• Module 4: Nonclinical reports
• Module 5: Clinical reports

7. The CTD
Triangle

8. Module 1.
Administrative information and prescribing
information.
Document specific to each region.
E.g. Application form
Proposed label for use in the region

9. Module 2. CTD summaries
2.1 Table of content
2.2 Introduction
2.3 Quality overall summaries
2.4 Non-clinical overview
2.5 Clinical overview
2.6 Non-clinical summaries
2.7 Clinical summaries

10. 2.3 Quality overall summaries
Should provide the reviewer with an
overview of module 3.
Should identify the critical key
parameters and give justification
where guidelines are not followed.

11. 2.4 Non-clinical overview
Non-clinical data with it’s interpretation
Clinical relevance of findings
Implications of the findings for the safe
use of the product.

12. 2.5 Clinical overview
Summary and analysis of the clinical data
Overview of clinical findings
Important limitations
Evaluation of benefits and risks based on
conclusion.

13. 2.6 Non-clinical summaries
Summary of pharmacokinetic,
pharmacological and toxicology studies –
in-vivo/in-vitro, species, route and
duration
Appropriate age and gender related
effects

14. 2.7 Clinical summaries
Detailed summarization of the
clinical information in module 5.
Post marketing data for products
that have marketed in other
regions.

15. Module 3 Quality
Chemical-pharmaceutical information and biological
information
Table of content to direct reviewer around the document
Provide body of data as follow:

16. Module 4 - 5
Non-clinical and clinical study reports
Table of content
Location of each study reports in the CTD
Not indicate the studies required to
support the application.

17. Current status of CTD
Nov, 2000, in San Diego, Step 4 status
Step 4 – Final draft is recommended for adoption to the
regulatory bodies (EU, Japan and USA)
Modules – additional formatting and integration of the
components of the CTD
May, 2001, Tokyo, a set of principles for the uniform
formatting of the CTD
Oct, 2001, FDA published, eCTD.

18. Advantages of CTD
• To save time and resources
• To facilitate regulatory review and communications
• Appropriate format for the data
• Easy to understand and evaluation of data
• Applicable to all types of products (NCE,
radiopharmaceuticals, vaccines, herbals, etc.)

19. Not included in CTD
• No detailed information about content of dossier
• Which studies/data required for a successful approval
• Still not identical for all regions (different regional
requirements)

20. Shortcomings of CTD
• CTD is only a format, its not a single dossier with a
single content.
• Legal requirements differ in three regions
• ICH guidelines have not yet harmonized in all
requirements
• Pharmacopoeias are not harmonized
• Applicant may have regional preferences.

21. Benefits of CTD
• Resources savings in building the dossier
• Single summaries
• Facilitation of regulatory information exchange
• Facilitation of response to questions
• Harmonized format allowing electronic transmission
• Partially identical data package
• No actual increase in EU and / or Japanese application
size/review time

22. Conclusion
• Whilst the realization of the CTD took many years, there
is now a common format for the submission of
Marketing Authorizations Applications across the three
ICH regions - Europe, Japan and the USA. This should
facilitate pharmaceutical companies to make
simultaneous filings in the ICH regions as it will
eliminate the extensive work previously required to
convert, for example, a US dossier to an EU dossier and
vice versa.

23. Thank you
Bindu Kshtriya