eCTD Training on Electronic Common Technical Document Standards
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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.
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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
- 6. Folder Structure Sections with specific information in folder names 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
- 14. Each Section/Tab represents a PDF File OPL
- 15. X M L OPL
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- 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
- 25. Comparing paper CTD and eCTD 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
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