1. JSS College of Pharmacy Ooty, Tamil Nadu Sunday, April 24th , 2016
Understanding eCTD Fundamentals and creating your first eCTD Submission
JSS College of Pharmacy
Ooty, Tamil Nadu
Sunday, April 24th , 2016

2. Objectives of the Workshop
Understand the basics and terminologies of eCTD
Demo on how to create FDA compliant dossiers using PharmaReadyTM eCTD
Hands-on training on using PharmaReadyTM to create your first eCTD submission
Q & A

3. G L O S S A R Y CTD – Common Technical Document
ICH - International Conference on Harmonisation
eCTD – Electronic Common Technical Document
NeES – Non-eCTD Electronic Submission
RIMS – Regulatory Information Management System
GCC - Gulf Cooperation Council
EMA - European Medicines Agency
NCA - National Competent Authorities
XML – eXtensible Markup Language
XSL – eXtensible Stylesheet Language
DTD – Document Type Definition

4. Agenda Overview of Regulatory Submissions & their Structure
Overview of eCTD
eCTD basics and terminology, eCTD architecture
The XML backbone, File formats, Folder Structure
Guidelines and Granularity, Study Tagging Files
Checklists and Validation Criteria, Submission Ready Documents
DTDs and Style sheets in the Util folder
Dossier Preparation using PharmaReadyTM eCTD

5. Overview of Regulatory Submissions & Their Structure
Understanding eCTD Fundamentals and creating your first eCTD Submission
Overview of Regulatory Submissions & Their Structure

6. Regulatory Submissions
Why? Need to gain approval from Regulatory agencies to market pharmaceutical drug products in their respective countries
When? Innovator discovers a new molecule, Formulator knows of a patent expiration, API Manufacturer markets Drug Substance, Annual Reports, Amendments, etc.
What? Administrative, prescription, manufacturing, CMC, quality, non-clinical and clinical study information
How? Paper, Non-eCTD Electronic Submission (NeES), electronic Common Technical Document (eCTD)
Whom? ICH Countries (US, EU, JP, CA) and Emerging Markets (TGA, MCC, Africa, South East Asia, Latin America, etc.)

7. Regulatory Submissions – contd.
Phases

8. Regulatory Submissions – contd.
Partial list of Regions and Countries for Regulatory Submissions
GCC (Saudi Arabia, Oman, UAE, etc.)
LEVANT (Turkey, Israel, Jordan, Lebanon, Palestine, Northern Cyprus, Syria)
ASEAN (Malaysia, Singapore, Thailand)
APAC (Australia, Brunei, Cambodia, etc.)
EU (England, Austria, Belgium, etc.)
CEE (Albania, Slovakia, Croatia, etc.)
Some important MoH Websites:

9. CTD Structure CTD stands for Common Technical Document
It is a logical ordering and organization of information
It is a way of managing information at the document level
1. Came into effect in 2000
2. Adopted by ICH (International Conference on Harmonisation)
3. Organisation of the data into modules and nodes

10. Benefits of eCTD Financial Improved Application Review Process
Printing and shipping costs are eliminated
Application can be submitted in multiple countries with relatively minor changes
Reduce review times, increase your response times to Agency requests, and ultimately lead to a faster approval
Improved Application Review Process
Most Agency reviewers prefer eCTD vs. paper
Submissions can be uploaded to the Electronic Submissions Gateway (ESG) and are available to reviewers within hours
Thanks to bookmarks and hyperlinks, a reviewer can easily jump to the paper you just cited, the table you just mentioned, or the validation report you just referenced
Reviewers no longer have to search through countless paper volumes to determine what changes have been made to an application
Convenience
Multiple people can access the same documents at the same time – no more sharing paper volumes or making extra copies
Agency employees can access the application remotely, allowing reviewers to continue their review regardless of their location
Agency can audit the software used to create the eCTD submission during site inspections

11. Understanding eCTD Fundamentals and creating your first eCTD Submission
Overview of eCTD

12. Overview of eCTD eCTD Terminology XML Backbone Application/Sequence
Granularity
Life cycle
Checksum
Href path
Attribute
LeafID
Folder
Util/Stylesheet/DTD
STF

13. Fundamentals of eCTD – contd.
eCTD Folder View
eCTD Browser View

14. Fundamentals of eCTD – contd.
Backbone XML View

15. Quick look into the Market Requirements
Understanding eCTD Fundamentals and creating your first eCTD Submission
Quick look into the Market Requirements

16. Electronic Submissions to US
Application Types – FDA
IND (Investigational New Drug Application)
NDA (New Drug Application)
ANDA (Abbreviated New Drug Application)
DMF (Drug Master File)
BLA (Biological license Application)
FDA recommends sponsors to submit a pilot submission for technical evaluation
Submission Types – FDA
Original Application
Amendment
Re-submission
Pre-submission
Annual Report
Establishment Description Supplement
Efficacy Supplement
Labeling Supplement
CMC Supplement
Other

17. Electronic Submissions to US – contd.
Unique FDA Submission Requirements:
Filled out Form 356h (ANDA)
Annotated Label and Proposed Labeling Text
Side by Side comparison of Labeling Text with RLD (ANDA)
Signed, Executed Batch Records
Study Tagging Files (STF)
Clinical Study Reports (CSR)
Case Report Form (CRF)
Section Case Report Forms no longer used
Application number is always 6 digits
All Drug Listings must be sent via Electronic Submission Gateway (ESG)

18. Document Publishing Standards
All PDF documents must be between versions 1.4 and 1.7
All PDF documents that have more than 5 pages must have bookmarks and a table of contents that is linked to the respective pages. The bookmarks must generally match the table of contents
The ZOOM levels for all the bookmarks and hyperlinks must be set to “Inherit Zoom” only
The PDF document must be made searchable, or, should be OCRd if scanned and saved as PDF file
The initial view should be set to “Bookmarks Panel and Page” if the PDF document has bookmarks. Else, should be set to “Page only”
“Fast Web Access” and “Most Recent View” must always be enabled in all PDF documents

19. PharmaReadyTM Demo and Hands-On Training
Understanding eCTD Fundamentals and creating your first eCTD Submission
PharmaReadyTM Demo and Hands-On Training

20. PharmaReady Demo and Hands-on Training
Creation of an ANDA Application for the Drug Product “WonderDrug”
Creation of the Initial Sequence (0000) with relevant Submission type
Loading of the Modules M1 to M5
Choosing the proper attributes for Drug Substance and Drug Product
Adding Documents into the sequence using Drag and Drop
Creation of Study Tagging Files
Compiling and Validating the Sequence
Creating Hyperlinks across documents for easier navigation
Validating and Publishing the Sequence
Creation of Amendment (sequence 0001) and Life Cycle Management of Documents
Viewing the sequences 0000 and 0001 in the Consolidated Viewer – just as what is seen by FDA reviewers

21. Thank You Rajesh Prabu S.S. rajesh.prabu@navitas.net +91-9952758905