CTD and eCTD

BY-
MADHAVI GUPTA
M.PHARMA 1st SEM
PHARMACEUTICS

 It is defined for a paper submission as a
set of pages, numbered sequentially and
divided from other documents by a tab.
 A document can be equated to a file for
an electronic submission.

CTD WAS OFFICIALLY SIGNED OFF IN
NOVEMBER 2000, AT 5TH ICH CONFERENCE,
SAN DIEGO,CALIFORNIA.
CTD eCTD

The objective is to increase international
harmonization of technical requirements to ensure
that safe, effective, and high quality medicines are
developed and registered in the most efficient and
cost‐effective manner.
Activities have been undertaken to promote public
health, prevent unnecessary duplication.

What is ICH ?
• The complete name of ICH is the "International Conference
on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use".
• The purpose is to make recommendations on ways to achieve
greater harmonization in the interpretation and application of
technical guidelines and requirements for product registration
in order to reduce or prevent the need to duplicate the testing
carried out during the research and development of new
medicines.
• This unique project brings together the participants in the
three regions to discuss scientific and technical aspects of product
registration

The focus of the is to provide a common format for the
preparation of a well structured submission according
to the modular framework described in the ICH
guidelines of the Common Technical Document for
Registration for Human Use (ICH Topic M4).
 The CTD guidance indicates where and how
available information is to be presented.
 The CTD is not intended to indicate what studies are
actually required (Authorities can ask for specific types
of data).

CTD is a joint effort of 3 Regulatory Agencies-
 European Medicines Agency (EMEA, Europe)
 Food and Drug Administration (FDA, USA) and
 Ministry of Health, Labour and Welfare (MHLW,
Japan).
CTD is maintained by ICH through Expert working
group (EWG). It has been adopted by several
other countries including Canada and Switzerland

These different steps are called STATUS of that
Guideline-
STATUS FUNCTIONALITY
STEP 1 Development of Consensus
STEP 2 Text released for Consultation
STEP 3 Consultation outside ICH
STEP 4 ICH Guidelines Finalized
STEP 5 Implementation

Avoid generating and compiling different registration
dossiers Common format will significantly reduce the
time and resources Facilitates simultaneous submission
in three regions Facilitates exchange of information
among regulatory authorities Faster availability of new
medicines.

The CTD is organized into FIVE modules:
 Module 1: Regional Administrative Information.
 Module 2: Introduction, Quality Overall Summary,
Nonclinical Overview, Clinical Overview, Nonclinical
Written and Tabulated Summaries, Clinical Summary
 Module 3: Quality
 Module 4: Nonclinical Study Reports
 Module 5: Clinical Study Reports.

The Common Technical Document is
organized into five modules. Module 1 is
region specific and modules 2, 3, 4 and 5 are
intended to be common for all regions.

1. ADMINISTRATIVE
1.1 FDA form 356h
1.2 Cover letter
1.3 Patent information
1.4 Department Certification
1.5 Field copy certification
1.6 User Fee cover sheet
1.7 Financial disclosure information

2.1 CTD Table of content
2.2 CTD Introduction
2.3 Quality Control Summary
2.4 Non-Clinical Overview
2.5 Clinical Overview
2.6 Non Clinical Summary
2.7 Clinical Summary

• The eCTD is the electronic equivalent to the CTD.
Why electronic?
–Improve the submission and review process
–Increase accuracy of the submission
–Decrease total costs
• This specification has been developed by the ICH
M2 Expert Working group and maintained by the
eCTD Implementation Working group in accordance
with the ICH Process.

eCTD Changes
• XML based eCTD backbone replaces PDF Tables of Content
(index xml file). The purpose of this file is two‐fold:
• Manage meta‐data for the entire submission
• Constitute a comprehensive table of contents and provide
corresponding navigation aid
• Increase document granularity in accordance with ICH eCTD
agreements.
• Life Cycle Management:
–Composed at least of an initial submission
–Incremental updates
–Only what was changed needs to be re‐submitted

eCTD Specification v 3.2
eCTD is a message specification for the transfer
of files and metadata from industry to regulatory.
The eCTD Specification version 3.2 describes
many optional folders and file names.

eCTD SUBMISSION CHECKLIST-
 eCTD Software
 Software training and support from the supplier
 Compiling and eCTD
 eCTD hyper linking
 QC of eCTD
 Submit eCTD on CD/DVD or Use electronic gateway

eCTD Implementation-
eCTD is implemented in 2009
• ICH‐eCTD is an internationally driven standard designed to
reduce cost in the administration, assessment and archiving of
applications for marketing authorization of medicinal products
for human use, to reduce the use of paper and streamline the
assessment process making the system more efficient.
• Unlike CTD the eCTD is not mandatory in Europe (highly
recommended).
• NCAs are progressively adapting their infrastructure,
processes and legislation to be able to receive and handle
paperless applications for marketing authorization by 2009.

Benefits of eCTD
• Improved handling and archiving of submissions
• Better information management Support of Life Cycle
Management
• Immediate Access to complete and up‐to‐date information
• Search functionality for assessors and increased tracking
ability
• Facilitated evaluation and better visibility of the process
• Reduced workload and reuse of information for assessment
reports
• Controlled communication with external experts
• Better use of resources
• Simplified business process
• Better communication with industry

SFDA Plan for Submission-
• Application form should be submitted online
• SFDA will require the product file in both CTD (Hardcopy)
and eCTD (Softcopy) format
• Product file registration should follow the current
requirements, but in CTD format

SFDA Prospective for Submission
• Learning process
• Step by step implementation
• Review of the business process
• Build a workflow system
• Pilot phase
• Smooth transition

CTD and eCTD

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