This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Bangalore Call Girl Whatsapp Number 100% Complete Your Sexual Needs
eCTD Training on Electronic Common Technical Document Standards
1. Presented by Md. Zakaria Faruki
Asst. Manager, Quality Assurance
OPL
Training on
Electronic Common Technical
Document (eCTD)
2. The ICH
The International Conference on Harmonisation (ICH) was formed in
April 1990 hosted by EFPIA (European Federation of Pharmaceutical
Industries and Associations) in Brussels as a joint regulatory
consortium to bring together the technical requirements of respective
regulatory agencies and standardize the common portions of drug
applications.
Observers
OPL
3. Common Technical Document (CTD)
Representatives of the regulatory agencies and industry
associations of EU, Japan and the US.
OPL
4. eSubmissions History
Began in late 80’s but insufficient IT capabilities
1995 – FDA used PDF files with hyperlinks
1997 – CTD topic of ICH4
2001 – first eCTD guideline
2003 – CTD mandatory in EU and first eCTDs submitted
2006 – lifecycle management a challenge
In 2007,eCTDs represented 10% of total submissions to CDER.
2008 – only electronic submissions accepted (either eCTD or non-eCTD)
2009 – strongly recommend only eCTD format electronic submissions to be
accepted. Paper and other electronic formats to be exception in the EMEA
It is expected that by the end of 2012, eCTD submissions may represent 40 or 50%
of total submissions to CDER (Center for Drug Evaluation and Research).
OPL
5. What does eCTD consist of?
Folder or tree structure
XML backbone file is Table of Contents
Additional information (Document type definition – rule book
for tags and attributes)
Regional information and files
OPL
7. Preparing documents
Templates should be used where possible
Documents to be:
technically correct
have the right granularity
conform to external regulations/guidelines
consistent with internal standards and styles – naming
conventions, etc.
‘intelligent’ PDF files
OPL
8. Concept of Reuse
Submit a document once, never submit again.
Concept of Granularity
Authoring in smaller pieces (granules), allows for greater
flexibility and reuse in the context of submissions.
If documents are formatted according to ICH granularity and
content needs to change, only those documents that contain new
content will need to be replaced (or appended) and submitted
not the entire section or study report.
OPL
9. What is XML?
Extensible Markup Language (XML) is an electronic
document and data exchange standard.
XML vs. HTML?
XML describes and focuses on data. It is information
wrapped in tags that requires another piece of software to
send, receive or display it. The tags are not predefined. XML
is a complement to HTML.
HTML displays data and focuses on the appearance of data.
Tags are predefined.
OPL
10. DTD
The purpose of the DTD is to define the building blocks that
can be used in an XML document. It defines the names to be
used for the different types of elements, as well as where they
may occur and how they all fit together.
XSL
Style sheets, or Extensible Style Sheet Language (XSL),
are files that define the look of the content, including font sizes,
colors, margins, etc.
OPL
11. Metadata
Regional Information
Company Name
Application Number
Date of Submission
Product Name and Type
Application Type
Submission Type
ICH Information
Product, Dosage Form,
Manufacturer, Excipient
Substance & Manufacturer
Indication
Novel Excipient
OPL
18. eCTD Software Vendors
1) Extedo / IABG Life Sciences-:
eCTDmanager is an off-the-shelf submission management system of highest quality
and functionality. It provides the eCTD functions of building, viewing, validating and
publishing (electronic and paper) and enables the easy-to-use compilation of
compliant electronic dossiers based on CTD, eCTD and other dossier structures.
2) eCTD Xpress:
eCTD XPress is ISI’s latest web-based solution for creating, managing eCTD lifecycles,
and reviewing eCTD submissions. The application satisfies both regulatory agencies’
and industry sponsors’ requirements for reviewing, compiling, publishing and
archiving of multi-region eCTD submissions. eCTDXPress allows users to separate
technology from content, which improves productivity and time-to-market.
3) Submission Accelerator for eCTD:
It is a complimentary module for CoreDossier® -- automates the assembly and
publishing of compliant eCTD dossiers, including the XML backbones for regional
content.
OPL
21. Granularity
Defines how the completed document is broken down,
tagged and stored for reuse
Determines smallest piece of information that is reusable
Changing granularity during lifecycle is difficult, therefore
must be planned at the beginning.
FDA Guidance
Each document should be provided as a separate file
OPL
22. ‘intelligent’ PDF files
A file converted to special PDF format enabling links and
bookmarks to be applied, and hence is searchable.
Cross referencing documents
Intradocument links – bookmarks
Most intradocument links can be automatically set using
templates
To set each link manually would take MANY hours
Interdocument links
Cross reference documents in context of other documents.
OPL
23. Cross referencing submissions
Inter submission links
Cross references of submissions in context of other
submissions, e.g. variations.
Time frames
Once all documents are written, checked and formatted
setting bookmarks and links take from 2 to 12 weeks.
OPL
24. Eye openers
Global application
Life cycle history easily accessible
Ease of compilation and review once system is up and running
Intersubmission checks made possible by both applicant and
reviewer
Authenticity of documentation easy to verify.
bombshell
Extensive software programme needed to support the system
Software programme used in EU costs €20,000 per USER
Extensive IT support needed by applicant and regulator.
OPL
26. Conclusion
Great idea but need intermediate steps to get there
CTD format to be adopted immediately
NeeS in interim
Essential to join electronic bandwagon
To explore the stages of developing an eCTD strategy and
approach.
OPL
27. Strategy & Approach
Save a Tree!!
• NCE is approx 240,000 pages, Paper for this would be 672 kg, Equivalent to ONE
average tree.
•An entire tree is required to submit a single copy of the application form one
applicant to one health authority
OPL