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ECTD BY NITESH
1. .
ASSIGNMENT ON:
ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD)
SUBMITTED TO:
DR. DIMPLE
CHOPRA
SUBMITTED BY:
NITESH KUMAR
M.PHARM (1ST SEM.)
21301135
DEPARTMENT OF PHARMACEUTICAL SCIENCES AND DRUG
RESEARCH
PUNJABI UNIVERSITY, PATIALA
147002
2. • The CTD is a set of specifications for a dossier for the registration of
medicines . 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 . Its electronic version is called eCTD.
• eCTD (electronic Common Technical Document) is a standard format
of submitting Regulatory information (such as applications,
supplements, and reports) to the concerned Health Authorities (HAs).
• This guideline provides recommendations to applicants on electronic
submissions with the electronic Common Technical Document for the
Registration of Medicines.
INTRODUCTION
3. In 2003 ectd was implemented in all ICH regions.
The major version (v4.0) was added by ICH M8 EWG in 2015.
4. Advantages of eCTD v4.0
Single
submission
unit message Document
Reuse
Context of use life
cycle
eCTD
submission
tracking
information
5. OBJECTIVE
1. Establishing a worldwide standard for electronic submissions.
eCTD has been turned into the standard norm for industry-wide
submissions around the world.
2. It give more accountability and ease decision making .
3. The purpose of introducing eCTD was to reduce the burden on
the reviewers of the HAs.
4. It also simplifies the process of submission as all the Regulatory
authorities use it as a standard format.
6. FORMATE OF eCTD
• Module1 – administration information (specific region)
• Module 2 – summaries.
• Module3 – Quality.
• Module4 - non clinical study report .
• Module5 - clinical study report.
8. STRUCTURE FORMATE FOLDER
• e-Identifier Number:Every application is
given a unique number by the Agency which
becomes the top-level folder.
• eCTD Sequence Number: Every submission
is given a sequential 4 digit number. The
initial filing submitted in eCTD format is
usually 0000.
• Module 1 National/Regional administrative
data.
• Modules 2 to 5 follow ICH CTD granularity
Util
folder
Working documents
XML
9.
10. eCTD UTIL FOLDER
Style folder DTD folder
Contains the Regional
and ICH DTD/schema
files for Module 1 and
Modules 2-5 .
Contains the Regional
and ICH stylesheets for
Module 1 and Modules
2 to 5.
.
11.
12. XML is backbone of eCTD
XML FILES
index-md5.txt
file
INDEX XML
Forming table content
submission unit,
metadata submission
unit
xx-
regional.xml
File
Backbone of m1
is the overall checksum for
Submission.
13. META DATA
• Metadata is data about data.
• Structural metadata is used in eCTD to organize information by
specific criteria; identification of data, grouping and dividing data, and
the location of information.
14. Leaf titles
Leaf titles including meaningful
information in leaf titles makes
submissions easier to navigate and
facilitates the evaluator’s task.
The leaf titles should be short,
meaningful and indicative of the
document’s content, so that
someone who isn’t familiar with the
application would know what the
document is from the leaf title
without having to open the
document.
15. Module 1
1. This module contains administrative information that is unique
for each region.
2. Regional guidance will provide the specific instructions on how to
provide the administrative forms and detailed
prescribing information.
3. It is not a part of eCTD. Because it is specific for particular region.
4. Authorities have additional documentation requirements (eg. batch
analysis , method validation reports).
16. FOLDER
3.1.1 FDA Regional eCTD Backbone Files 3.1.7 Information
Amendments
3.1.2 Cover Letter and Reviewers Guide 3.1.8 Risk Evaluation and
Mitigation Strategy (REMS)
3.1.3 Patient Experience Data
3.1.5 Labelling
3.1.6 Advertisements and Promotional
Labeling Material
17. Module 2
• The files in this module should be provided as PDF text
with the exception of a few embedded images, when needed. The
name of the folder for module 2 should be m2.
SECTION OF
ECTD
DESCRIPTION FOLDER NAME
2.2 INTRODUCTION 22-intro
2.3 QUALITY OVERALL SUMMARY 23-qos
2.4 NON-CLINICAL OVERVIEW 24-nonclin-over
2.5 CLINICAL OVERVIEW 25 -clin-over
2.6 CLINICAL SUMMARY 26--clin-sum
18. MODULE 3 QUALITY
CTD Module 3 is the section of the common technical document (CTD)
regulatory submissions format that contains all the required quality
information and data corresponding to the registration of a
pharmaceutical product.
SECTION DISCRIPTION FOLDER NAME
3.1 Drug
substance [Drug Substance Name]
[Manufacturer]2
substance-1-
manufacturer-1
3.2 Manufacture (name, manufacturer) 32s2-manuf
3.3 Reference Standards or
Materials (name, dosage form)
32s5-ref-stand
3.4 Stability (name, dosage form) 32s7-stab
3.5 Description and Composition of
the Drug Product (name, dosage form)
32p1-desc-comp
3.6 Validation of Analytical Procedures 32p53-val-analyt-
proc
19. Granularity
An enhanced granularity is required in this module and to make easy to
review/readable. The granularity should be built with Node Extensions(
additional folder of granular) and Subfolders including numbering of the
subfolders. Further information can be found in these folder.
20. MODULE 4 . Non - clinical study report
SECTION DISCRIPTION FOLDER NAME
4.1 STUDY REPORT 41-stud-rep
4.2 PHARMACOLOGY 42pharmacol
4.3 PHARMACOKINETICS 43pk
4.4 PHARMACODYNAMIC 44-pd-drug
4.5 TOXICOLOGY 45-tox
21. MODULE 5 . clinical study report
SECTION DESCRIPT FOLDER NAME
5.1 CLINICAL STUDY REPORT 51-clin-stud-rep
5.2 REPORT OF BIOPHARMACEUTICS STUDIES 52-rep-biopharm-stud
5.3 Reports of Human Pharmacokinetic (PK) Studies 53-rep-human-pk-stud
5.4 Reports of Human Pharmacodynamic (PD) Studies 54-rep-human-pd-stud
5.5 Reports of Efficacy and Safety Studies 55-rep-effic-safety-stud
5.6 Reports of Post marketing Experience 56-postmark-exp
22. WORKING DOCUMENTS
Additional documents required to be submitted alongside the
eCTD content. Some examples of what may be required are
document or versions of PDF content, and the eCTD validation
report.
23. TECHNICAL REQUIREMENTS FOR SUBMISSIONS
Submission
media
PDF files
Hyperlink
s and
Bookmark
s
MD5
checksum
Virus
check
24. 1)Submission media : -
The following media formats will be accepted for eCTD submissions
CD-ROMs (conforming to ISO 9660 or ISO 13346)
DVD-ROMS
USB drives (2.0 or higher)
2) PDF FILES:-
Portable Document Format (PDF) is an electronic format and PDF v1.4 -1.7
Resolution 300 dpi (photographs up to 600 dpi)
Acceptable file size is approx. 200MB.
Pixels 1024*768
Times New Roman 12-point font text and 10 font for table .
The International Color Consortium (ICC)6 color profile specification is
used .
25. 3) HYPERLINKS AND BOOKMARKS:-
hypertext links are blue color text and encouraged within the eCTD to
facilitate swift navigation within the dossier. The eCTD should be structured
and links provided in such a way as to ensure that the reviewer is constantly
aware of the overall structure and narrative flow of the dossier.
4) MD5 CHECK SUM
A checksum is unique identifier used to verify the integrity of file by
comparing two set of data to make sure they are same .A checksum (MD5)
should be included for each file in the eCTD, allowing the recipient to verify
the integrity of physical files in the submission. It is generated by applicant to
check integrity of file.
5)VIRUS CHECK
The applicant is responsible for checking the virus in submission unit.
26. Validation is process that ensure the eCTD dossier is technically correct after
review the submission.
VALIDATION
Categories of Validation Rules
Pass/Fail Criteria Best Practice Criteria
28. LIFE CYCLE MANAGEMENT (LCM)
An eCTD application is an evolving entity that grow with each
submission (sequence).
1. Life cycle management at the submission layer (i.e. eCTD-sequence)
2. Life cycle management at the document layer (eCTD leaf)
3. Life cycle management of specific documents.
4. Responses to Authority Recommendations.
5. Tabulated Schedule of Amendment.
29. BASELINE SUBMISSIONS
A baseline submission marks the change from a paper based
submission, or an e-submission, to an eCTD submission
The paper copies and the hard media should be submitted jointly. The
eCTD on DVD/CD/USB should be submitted at specified address of RA.
SUBMISSION
