Module 4 - Pharmexcil

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Dr Milind Joshi
President – Global Regulatory Management
Electronic Submissions – eCTD Advantages
J. B. Chemicals & Pharmaceuticals Ltd.
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Change is the only universal constant
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© Copyright 2005 J. B. Chemicals Pvt. Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Data Management and Review
 Every regulatory submission is data submission
 Dossier structure is complicated
 Variety
 Quantity
 Lack of clarity
 Confusing and cumbersome review process
 Voluminous data
 Diverse data
 Multiple expertise needed for complete review
 Evolution
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
CTD – Structure
 Module 1 is
not part of
CTD
 Contains
regional
information
and
prescribing
information
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD Modules
 Module 1 ( Region specific Information)
Environmental Assessment, declarations and forms
 Module 2 ( Summaries)
- 2.3.Quality overall Summary
- and Summary of Modules 4 and 5 (e.g. BE Tables)

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Module 3
Drug substance
Drug Product
Appendices
Batch information
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD Modules ( contd..)
Module 4
 Non-Clinical study report and related data
Module 5
 Clinical study reports , CRFs, & In –vitro
comparative dissolution data, etc.
 Bioequivalence studies in ANDA submission
 STF (study tagging files) submission
 STFs required by Unites states, optional in Europe
& Japan
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Data / Dossier Structure
Old times
CTD
eCTD
Administrative /
Regional
Administrative / Regional
Module 1
Administrative / Regional
Module 1
Chemistry
Manufacture
Control
Quality
Module 3
Quality
Module 3
Non-Clinical /
Clinical / BE
Non-Clinical
Module 4
Non-Clinical
Module 4
Clinical/BE
Module 5
Clinical/BE
Module 5
Summary /
Synopsis
Summary
Module 2
Summary
Module 2
No set structure
Set structure but without
granularity
Very definite structure with
detailed granularity
Xml backbone
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
CTD – Common Technical Document
 Technical Document – data necessary for proving
safety, efficacy and quality of a drug product
 CTD – initiative to formalise the technical data
 Wide acceptance of the format
 Led to discipline in catagorising and presentation of
data
 Facilitated the review procedure of the huge data
 Still many copies of data needed, repeat efforts and
confusions unavoidable
 Updates in data and version control was
cumbersome
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD – Electronic CTD
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The format for data compilation remains same
Presentation is electronic and not paper
Undergoing evolution in eCTD for last few years
Initiative for better metadata and data management
Initiative for searchability and faster review
Initiative for better version control and change
management
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD
 Data that used to be submitted on paper, is submitted
on a CD / uploaded on a server
 Like guidance for how paper should be, there is
guidance for how the files should be
 Specific software / application for formation of eCTD
 Choice of software / application
 Knowledge of not just regulatory requirements but
also IT aspects
 Not just QbD for product but also Accuracy by Design
for data compilation
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD Emergence
Paper submission  NeeS  eCTD
Late 80’s  2008 for complete transfer at USFDA
 Disadvantages of Paper Submission
 Exponentially increased number of dossiers any MoH
/ Regulatory Authority receives in recent times
 Need for faster and more efficient review
 Need for better searchability, user friendliness and
harmonisation
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Disadvantages of Paper Submissions
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Voluminous data – difficult to handle
Person dependant for storage and retrieval
Not searchable
Not reusable
Can be lost
Can not be secured
Updates in data is difficult to track
Difficult version control
Eco-friendly (One copy of CTD dossier = 1 tree)
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD
 Most far-reaching change in regulatory data
management
 Needs upgradation and learning at different levels in
a company
 Constantly changing / evolving hence needs constant
training
 Management needs to approve the high end software
facility or out-sourcing fees
 Regulatory officers / executive should learn the
detailed requirements – not just pharma-technical but
also IT-technical
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
CTD & eCTD
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Scientific approach
CTD mandatory in the ASEAN, USA, EU & Japan
eCTD ‘must’ for USFDA
Common dossier for all countries with different
Module 1 with regional information
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Infrastructure created at USFDA for eCTD
Document management capability at USFDA
Version control at USFDA & at user’s end
Paperless
Reduced review time
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Submission Review Tools
 Tools provided on an as-is basis with no support from
FDA
 Support from 3rd party tools developers to submit and
validation of submission prior to FDA submissions.
 Adherence to the eCTD specification is critical
 Validation of the submission very crucial
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Review Process
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD Requirements
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File formats – pdf, xpt, doc, jpg
Doc, xpt and jpg files only allowed in certain modules
Software to have maximum granularity
All pdf files should be searchable / OCRed, vertically
oriented
Norms for file naming
Norms for title
Norms for how to write title and file name
Other norms of margins, fonts etc – same as paper
compilation
Thorough bookmarking and hyperlinking
No repeatation of data within metadata
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Requirements – Successful eCTD Application
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eCTD software ( Good support from vendor )
Quality of HR
IT infrastructure
Understanding of the software & regulatory guidance
Training & updating with current guidance
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
eCTD Advantages
 Handling of smaller physical form of data compilation
like CD
 No copies (coloured bound dossiers, field copies etc)
 Easily reviewable
 Searchable
 Life-cycle management of dossiers
 Easy updates
 Version control
 No repetition of data
 Maneuverability and easy cross-linking within metadata
 Maneuverability and easy cross-linking within data
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
Thank you !!!
[email protected]
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© Copyright 2005 J. B. Chemicals Pharma Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.
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