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CTD and eCTD Format
1. CTD and eCTD Format
Prepared By-Nikhil Thorane (M.pharm 1st Year)
Priyadarshini college of pharmacy, nagpur.
2. CTD
Common Technical Document [CTD]: It is an format set by ICH which was agreed by the
Regulatory Agencies of Europe , Japan & the U.S.
The FDA characterized the CTD as “An information package of clinical, non clinical,
manufacturing, technical data in the same content that would be submitted for registering
new drugs in all 3 ICH regions i.e. U.S,European Union and Japan.
3. History of CTD
The Concept of CTD was introduced by ICH in the year of 2000 for the public
consultation.
Before 2000 there was no uniformity to submit dossier in regulatory authority. This
creates many hassles for applicant as well as auditors to submit and reviewing the
dossier information in an organized manner. Hence concept of CTD was come for
harmonization in dossier submission.
It is important to note that on July 1, 2003 use of the CTD format will become
mandatory across all three regions like EU, FDA and Japan.
4. Impact of CTD
The ICH CTD represents one of the most ambitious and successful international
harmonization activities undertaken for medicines product of human use.
It will significantly reduce time and resources needed by industry to compile applications
for global registration.
Applies to all NDAs, ANDAs, BLAs and INDs application.
5. Benefits of CTD
Easy “Reviewable” applications.
Complete, well-organized submission.
More predictable format.
More consistent reviews.
Easier analysis across application.
Easier Exchange of information.
Facilitates electronic submission.
7. Module 1
Administrative Information [Region specific]
This module should contain documents specific to each region
The content & format of this module can be specified by the relevant regulatory
authorities.
8. Module 2
CTD Summaries [QOS]
It should begin with a general introduction to the pharmaceutical , including its pharmacological
class , mode of action & proposed clinical use. i.e. information should not exceed one page
It contain 7 sections in the following order:
-2.1 CTD TOC [Module 2 – 5] [Table Of Content]
-2.2 CTD Introduction
- 2.3 Quality Overall Summary
-2.4 Nonclinical overview
- 2.5 Clinical overview
- 2.6 Non clinical summary
- 2.7 Clinical summary
9. The organization of these summaries is described in 3 separate documents:
A] M4 Q – The CTD quality
B] M4 S – The CTD Safety
C] M4 E – The CTD Efficacy
10. Module 3
Quality [CMC]
3.1 TOC of Module 3
3.2 Body of Data
- 3.2. Drug substance
-Generall information
-Manufacture
-Characterisation
-Control of Drug Substance
-Reference Standards or Materials
-Stability
11. 3.4 DRUG PRODUCT
-Descriptionnn and Composition of the Drug Product
-Pharmaceutical Development
-Manufacture
-Control of Excipients
-Control of Drug Product
- Reference Standards or Materials
-Stability
13. Module 4
Non Clinical Study Reports
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
Clinical Study Reports
TOC of Module 5
5.2 Tabular listing of clinical studies
5.3 Clinical study reports
-5.3.1 Repots of biopharmaceutical study[BA-BE]
-5.3.2 Reports of PK [biomaterial] study
-5.3.3 Reports of PK studies
-5.3.4 Reports of PD studies
-5.3.5 Reports of Efficacy and safety studies
-5.3.6 Reports of Post marketing experience
-5.3.7 Case Report forms & Individual patient listings
5.4 Literature References
15. e CTD
It is electronic version of CTD, so called as electronicc common technical document [e
CTD]
e CTD composed of 2 types of specification
- Content specification – As defined by ICH
- Technical specification- Electronic softwares
CTD (pdf) (Paper)
eCTD XML backbone
16.
17. e CTD Characteristics
All Modules 1 to 5 have granularity options[ level of detail a document has ]
PDF documents linked via XML backbone
Increased document granularity.
Transparency of entire submission
Ease of navigation and review
18. Benefit of eCTD
Improve the submission and review process.
Increase accuracy of the Submission.
Decrease total costs.
Immediate access to complete and Up to date information.
Reduced Workload.
Better communication with industry.
19. Example of eCTD Software:
ROSETTA Regulatory Software
Pharmaready eCTD Product which is fully validated, international regulatory Compliant
software