j. b. chemicals & pharmaceuticals ltd. © copyright 2005 j. b. chemicals pharma ltd. electronic...

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


CTD – Structure

Module 1 is not part of CTD

Contains regional information and prescribing information


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


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


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


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


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


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


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


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)


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


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


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


Review Process


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


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


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


Thank you [email protected]

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