For Information About EDMS & Submission Publishing

• Structured Product Labeling (SPL) (Final)
• Study Data Tabulation Model
• FDA CDER & CBER Guidance Documents—Electronic Submissions (Draft)
• FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 1
• FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 2
• Acrobat & Plug-in Contacts
• Systems for e-Submissions
• Electronic Document Management Systems (EDMS)
• CTD/eCTD Information
• XML Vendors & Resources
• eCTD Overview

Structured Product Labeling (SPL) (Final)

• Providing Regulatory Submissions in Electronic Format – Content of Labeling. Posted 4/20/2005.
  • Fall 2005 implementation
  • Mandatory even if remainder of submission paper
  • Applies to marketing application & post-marketing submissions
    Uses HL7 Structured Product Labeling (SPL) specifications
    

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Study Data Tabulation Model

• FDA Public Meeting February 1, 2005
  
• Steps being taken by FDA to require submission in electronic format:
  • Stability datasets
  • Animal datasets
  • Human datasets
  • Analysis-ready datasets
• Profound change from business as usual:
  • Agency
  • Sponsors
  • CROs
  • Vendors
• Additional resources:
  • http://www.cdisc.org
  • http://www.hl7.org

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FDA CDER & CBER Guidance Documents—Electronic Submissions (Draft)

• Providing Regulatory Submissions in Electronic Format – General Considerations. Issued 10/2003.
  • Updates PDF requirements

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FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 1

• Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Applications and Related Submissions. Posted 8/28/2003

  • Federal Register Notice.
  • The Draft Guidance.
  • ICH eCTD Specification 3.0.

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FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 2

• FDA Module 1 Specification. Updated version posted 8/13/2003.
• FDA Modules 2-5 Specification.
• Study Tagging File Specification. Updated version posted 8/13/2003.
• FDA eCTD Table of Contents Headings and Hierarchy. Updated version posted 8/28/2003.

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Acrobat & Plug-in Contacts

• Adobe Systems, Inc.
• All things PDF:
• Appligent, Inc.
• Datafarm, Inc.
• DocMaestro Products
• Enfocus Software:
• Image Solutions, Inc.
• InfoData Systems, Inc.
• Quite Software:

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Systems for e-Submissions

• Datafarm, Inc. – eCTDViewer & eCTD Builder
• Extedo, Inc. - eSubmission Management
• Generis – CARA
• GlobalSubmit, Inc.
• Image Solutions, Inc. – eCTDXPress
• Liquent, Inc. – CoreDossier & EZsubs
• Lorenz International LLC
• MedXview, Inc. – eCTDcomposer & eCTDauditor
• OpenText, Inc.

Many vendors emerging to address eCTD.

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Electronic Document Management Systems (EDMS)

• EMC Software *
• First Consulting Group *
• QUMAS *
• FileNET, Inc.
• Hummingbird/PC DOCS
• MasterControl, Inc.
• Microsoft SharePoint Portal
• OpenText, Inc. *
• QUMAS *

*Integrated with submission publishing systems.

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CTD/eCTD Information

All things CTD:

• European Agency for the Evaluation of Medicinal Products. ICH M4 Common Technical document for the Registration of Pharmaceuticals for Human Use – Organisation CTD.
• European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA eCTD Topic Group.
• DIA membership-only website with links to EU regulatory authorities.
• PhRMA eCTD web site
• European Commission Enterprise Directorate – General Pharmaceuticals and Cosmetics Unit. Presentation and format of the dossier CTD. July 2004. CTD in Europe
• CTD/eCTD in Japan
• http://aboutctd.com However, sponsored by Liquent.
• http://www.ectd.com However, sponsored by Sendar Menlha Group International.
• Health Canada
• Online Resource for Markup Language Technologies
• Virtual Regulatory Services Ltd. However, sponsored by a service bureau.

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XML Vendors & Resources

• Altova, Inc. – Tools & Technologies for XML.
• Arbortext, Inc.
• IBM
• Microsoft
• O’Reilly International – Books on XML
• Organization for the Advancement of Structured Information Systems (OASIS)
• TIBCO Software Inc. TurboXML product

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eCTD Overview

• Electronic Review System starting point on CDER web site
• Recent presentations by FDA, from April 22, 2005 Tutorial

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