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J. B. Chemicals & Pharmaceuticals Ltd.
www.jbcpl.com © Copyright 2005 J. B. Chemicals Pharma Ltd.
Electronic Submissions – eCTD Advantages
Dr Milind JoshiPresident – Global Regulatory Management
Change is the only universal constant
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pvt. Ltd.
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
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
Data Management and Review
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
CTD – Structure
Module 1 is not part of CTD
Contains regional information and prescribing information
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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)
Module 3 - Drug substance- Drug Product- Appendices- Batch information
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
Data / Dossier StructureOld times CTD eCTD
Administrative / Regional
Administrative / RegionalModule 1
Administrative / RegionalModule 1
ChemistryManufactureControl
QualityModule 3
QualityModule 3
Non-Clinical / Clinical / BE
Non-Clinical Module 4
Non-ClinicalModule 4
Clinical/BEModule 5
Clinical/BEModule 5
Summary / Synopsis
SummaryModule 2
SummaryModule 2
No set structure Set structure but without granularity
Very definite structure with detailed granularityXml backbone
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
eCTD – Electronic CTD
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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
Disadvantages of Paper Submissions
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)
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
CTD & eCTD
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
Infrastructure created at USFDA for eCTD Document management capability at USFDA Version control at USFDA & at user’s end Paperless Reduced review time
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
Review Process
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
eCTD Requirements
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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
Requirements – Successful eCTD Application
eCTD software ( Good support from vendor ) Quality of HR IT infrastructure Understanding of the software & regulatory
guidance Training & updating with current guidance
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma 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
J. B. Chemicals & Pharmaceuticals Ltd.www.jbcpl.com. © Copyright 2005 J. B. Chemicals Pharma Ltd.
Thank you !!!milind@jbcpl.com
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