eCTD Submissions
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eCTD Submissions

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eCTD Submissions eCTD Submissions Presentation Transcript

  • eCTD Submissions Saikat Chakraborty
  • WHAT IS COMMON TECHNICAL DOCUMENT? CTD is an ICH standard that FDA adopted in a consensus process, as a member of ICH, together with other member regions, Europe and Japan Currently global format for regulatory submissions Consistent data organization Method to electronically transfer product information and data Collection of electronic files organized according to guidelines defining file format, folder/files naming convention, document specifications etc. Applies to all NDAs, ANDAs, BLAs, INDs and master files
  • The eCTD challenge In the US, eCTD-only NDAs, BLAs and INDs are accepted – no paper necessary eCTD plus paper still needed for Medical authorities in EU Paper is still the official archival copy of the EU MA EU wants eCTD as preferred format for all Marketing Authorization Applications(MAAs) and variations Only eCTD for MA for all EU members states by 1 Jan 2010 Health Canada wants eCTD format on CD/DVD plus paper
  • Accepting an Initial Marketing Authorization at the agency  100.000 pages represent ~ 250 volumes  250 volumes represent ~ 80 boxes  80 boxes represent approx. 3 – 4 palettes  3 – 4 palettes require a truck for transportation The technology and the legislation of today can change this!
  • NEED FOR ELECTRONIC SUBMISSIONS Designed with consideration that facilitate Creation Review Assists project management and information management Lifecycle management (the history of a product application) Archiving Drug development planning
  • Current Status of US eCTD Submissions FDA Office of Chief Information Officer Quarterly briefing, 12 Dec 2008 During the period 2005 to 2008, eCTD submission volume grew at a compounded annual growth rate of approximately 300%.
  • Barriers to adoption typically include: Costs (initial capital: $200K- $300K and annual expense: $100 - $200K) of building, validating and operating an electronic publishing system. Effort and time to learn and understand the regulatory requirements and to develop the organizational competency to efficiently produce compliant eCTD submissions. Growth of eCTD as a fraction of total submissions. In 2007, eCTDs represented 10% of total submissions to CDER. By February 2009, eCTDs were 20% of the total received. It is expected that by the end of 2012, eCTD submissions may represent 40 or 50% of total submissions to CDER.
  • Basics of eCTD The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD). The ICH M2 EWG has defined, in the current document, the specification for the Electronic Common Technical Document (eCTD). There are 5 modules in the submission report. A hierarchical cabinet/folder structure containing the electronic documents (PDF). An XML backbone that provides a structure to display the PDF documents in the eCTD format (eCTD viewer)
  • CTD STRUCTURE NOT Part of the CTD Regional Admin Information Module 1 Module 2 Nonclinical Clinical The CTD Overview Overview Quality Overall Nonclinical Clinical Summary Summary Summary Nonclinical Clinical Quality Study Reports Study Reports Module 3 Module 4 Module 5
  • Comparing paper CTD and eCTD
  • eCTD File Structure
  • Example of XML backbone
  • XML Mapping to Folder
  • Document Granularity All eCTD Submissions Include Module 1 Module 1 Identifies important information Company Name Drug Name Submission Type Submission Date Application Number Sequence Number
  • Module 2 – Summaries
  • Document granularity – Module 3 Module 3 consists of highly granular Quality documents that can be individually updated ICH eCTD specification and CTD guidance provides level of granularity Module 3 contains hundreds of granules in MA
  • Document Granularity – Module 3
  • Document granularity – Modules 4 and 5 Study report formats – Legacy report • Report components published and submitted as a single PDF with maximum size 100 MB – Granular report – US eCTD • Study documents submitted as separate PDF files as originally published
  • Module 4 contains the Preclinical data
  • Module 5 contains Clinical Study Data
  • Document Publishing Use tools based on Adobe Acrobat 5.0 or higher (PDF version 1.4) Publishing greatly facilitated by use of Word templates Automate extraction of bookmarks and hyperlinks from Word files Create PDFs from intelligent source- MS Office—Word, Excel, PowerPoint or Other word processors, spreadsheets, ASCII text etc. PDF should be text searchable, however some legacy document may only be available in scanned form
  • Document Processing Compare file names with document contents In PDF Check page size and orientation US accepts edocuments as A4 in eCTD EU MS require A4 paper dossier but you can submit letter- size PDF in an eCTD
  • Scanned Documents Avoid scanning unless no other choice If You Must Scan Document Type Resolution Handwritten notes 300 dpi (black ink) Plotter output graphics 300 dpi Photographs—b&w 600 dpi (8 bit gray scale) Photographs—color 600 dpi (24 bit RGB) Gels and karotypes 600 dpi (8 bit grayscale depth) High pressure liquid chromatography 300 dpi
  • Hypertext Linking Navigation improved for PDF documents Hypertext links for: „ Annotations „Related sections „References „ Appendices „Tables or figures „For anything not located on same page
  • Table of contents and hyperlinks Hyperlinks designated by blue text or rectangles with thin lines „Blue text for PDFs from intelligent source „Thin rectangles only option for scanned documents „Tables of Contents „Hyperlinked „Invisible rectangles and blue text preferred
  • Bookmarks and Hyperlink Bookmarks – Match the document TOC – Bookmarks – Up to level 4, e.g. 1.1.1.1 – For documents with multiple granules, each granule has its own bookmarks Provide Bookmarks with Intuitive Names Incorrect Correct
  • Bookmarks and Hyperlink One of the important aspect in eCTD reports is to maintain ‘inherit zoom’ throughout the document. eCTD publishing system should generate automatically. It can also be done manually with arcobat.
  • Bookmarks Hierarchy Initial View = Bookmarks & Page Page Numbering Document Page = PDF Page
  • File Naming & Folder/File Path Use lower cases letters Avoid special characters except hyphens File/folder path: 2 „ 30 characters for full folder/file path 6 „ 4 characters for folder names eCTD publishing system should generate/truncate automatically
  • Verbally Communicated Requirements Font size „12 point font for text „10 point for tables (9.5 pt) Font Style: Arial, Times New Roman, Courier Optimize for Fast Web View
  • QC of eCTD Precompilation QC interdocument links 100% QC that all bookmarks and hyperlinks are live 100% QC that all bookmarks and hyperlinks point to the correct targets Check all all documents for presence and location Check document titles in eCTD viewer Postcompilation Validate eCTD Recheck for broken links
  • Submitting the eCTD Cover letter (From the ICH eCTD spec, v. 3.2.2) as paper copy with any non-electronic portions and as cover.pdf A description of the submission including appropriate regulatory information. A listing of the sections of the submission filed as paper, electronic, or both paper and electronic. A description of the electronic submission including type and number of electronic media, Approximate size of the submission, and, if appropriate, characteristics concerning the media (e.g. Format used for DLT tapes) based on regional guidance.
  • Submitting an eCTD A statement that the submission is virus free with a description of the software used to check the files for viruses. The regulatory and information technology points of contact for the submission. Copy eCTD to CD-ROM, DVD or DLT master Reload eCTD from CD, DVD or DLT master and revalidate Create eCTD copies from master Number of copies determined by each EU MS
  • Points to Remember 1. Files Referenced in the XML Backbone(s) 2. eCTD Submissions Include Module 1 3. Application Numbers are 6 Digits 4. Sequence Numbers are 4 Digits 5. Ensure we receive what you intended 6. Do not send in one submission to be applied to multiple applications 7. XML must be Standard Components 8. PDF contains Recognizable Text 9. PDF Hyperlinks/Bookmarks are Correct 10.PDF Documents include TOCs
  • Closing Remarks The end is near for the traditional paper base era for managing, reviewing, and submitting regulatory submissions. Successful transtition to eCTD provides competitive advantages: Increased review efficiency Decreased risk of refusal to file Faster time to market H „ appier stockholders G „ reater employee & management satisfaction „Lower cost of production „Simultaneous global submissions „Healthier patients
  • References CDER Contact for information on eCTD submissions esub@fda.hhs.gov CDER Contact for information on SDTM submission cder-edata@fda.hhs.gov Electronic Regulatory Submissions and Review website http://www.fda.gov/cder/regulatory/ersr/default.htm • International Conference on Harmonization http://www.ich.org • All FDA Guidances on Electronic Submissions http://www.fda.gov/cder/guidance/index.htm#electronic_submissions