A decade of eCTD - Time to rejuvenate!
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A decade of eCTD - Time to rejuvenate!

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After 10 years of eCTD the standard is fit for rejuvenation. Although eCTD has brought many benefits there is still significant room for improvement. This presentation covers different areas: ...

After 10 years of eCTD the standard is fit for rejuvenation. Although eCTD has brought many benefits there is still significant room for improvement. This presentation covers different areas: continuous challenges associated with eCTD, Regulatory guidelines and eCTD viewing

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A decade of eCTD - Time to rejuvenate! A decade of eCTD - Time to rejuvenate! Presentation Transcript

  • A decade of eCTD: time to rejuvenate! Michiel Stam Manager Regulatory Operations Qdossier B.V.
  • Agenda Introduction Continuous challenges Regulatory guidance and specifications eCTD viewing eCTD: a rigid structure 12/5/2013 Copyright Qdossier B.V.
  • Introduction
  • Rejuvenation “the hypothetical reversal of the aging process.” Change directions, we can improve! 12/5/2013 Copyright Qdossier B.V.
  • The Aging process First European eCTD: 24th January 2003 eCTD v3.0 EU v0.9 Mandated by EMA (1st January 2010) Ability to accept e-only (January 2010) EMA Gateway (2012) (mandatory 1st March 2014 12/5/2013 Copyright Qdossier B.V.
  • Version history ICH eCTD specifications v3.0 (October 2003) v3.1 (November 2003) v3.2 (February 2004) v3.2.1 (June 2008) v3.2.2 (July 2008) 12/5/2013 EU m1 eCTD specifications v0.9 (November 2002) v1.0 (July 2004) v1.1 (December 2005) v1.2 (May 2006) v1.2.1 (October 2006) v1.3 (May 2008) v1.4 (August 2009) v1.4.1 (November 2011) v2.0 (September 2013) Copyright Qdossier B.V.
  • The benefits of e-only submissions Aspect Paper eCTD Transport -- + / ++ Handling/ Review - ++ Life cycle management -- + Archival -- ++ Costs -- + 12/5/2013 Copyright Qdossier B.V.
  • Continuous Challenges
  • XML Backbone Use the XML backbone! 12/5/2013 Huh?? Bone? Copyright Qdossier B.V.
  • eCTD viewer vs. Tracking approval Baseline of the current EU dossier please! 12/5/2013 Latest submitted or current approved? Copyright Qdossier B.V.
  • Current in eCTD vs. Current Approved Source: IRISS Life Cycle Group 2009 12/5/2013 Copyright Qdossier B.V.
  • Document Lifecycle status Life cycle operation: “New” Life cycle status: “Current” Approval status: “Under review” 12/5/2013 Copyright Qdossier B.V.
  • Regulatory Guidance and specifications
  • FDA –Providing Regulatory Submissions in Electronic Format (draft) “Although some eCTD tools generate leaf titles that are similar to file names, the two are not related.” All modules of the eCTD should contain descriptive eCTD leaf titles that are: Short Meaningful Indicative of each document's content Not including the eCTD section number 12/5/2013 Copyright Qdossier B.V.
  • Leaf titles vs. File names 12/5/2013 Copyright Qdossier B.V.
  • Swiss Medic - Providing Regulatory Information in eCTD Format version Hyperlinks are encouraged to facilitate navigation > should not be overused Only if necessary and of real added value. Important eCTD titles are consistent with cross references within other documents (e.g. summary document) Hyperlinks needed if title in eCTD ToC and reference in a summary document do not match 12/5/2013 Copyright Qdossier B.V.
  • Validation To assure that what has been submitted is fit for review by the validating agency Technical: Can technically be processed by agencies? Business: All data is available to examine the quality, safety and efficacy of the drug 12/5/2013 Copyright Qdossier B.V.
  • Technical validation > …. < Business validation Consistency in attribute values across sequences attributes, file names and folder names within a sequence Country codes Language codes PI Doc types Proper reference to “Related Sequence” 12/5/2013 Copyright Qdossier B.V.
  • Additional “common sense” checks Cover letter and Application form data is reflected correctly in the envelope Use of meaningful titles; e.g. Proof of Payment vs. Annex 5.2 Note to Reviewer vs. Annex 3 Stability Data Long Term Stability 24 M vs. Stability Data 1 Use of meaningful file names; e.g. de-form-proofpayment.pdf vs. de-form-5.pdf es-cover-notereviewer.pdf vs. es-cover-3.pdf stability-data-longterm24m.pdf vs. stability-data-1.pdf analytical-procedure-identityelisa.pdf validation-analytical-procedure-identityhplc.pdf 12/5/2013 Copyright Qdossier B.V.
  • Conflicting guidelines eCTD: “do not resubmit the same document” CTD (Renewals): “include a copy of the latest specifications” eCTD: leave empty CTD: placeholders “N/A” 12/5/2013 Copyright Qdossier B.V.
  • Controlled vocabulary “Regulatory activity” HL7: “the provision of information about a regulated product(s) requiring a scientific or regulatory outcome. An activity may include one or many exchanges (examples of exchanges may be eCTD sequences, RPS submission units, etc.)”. CESP: 12/5/2013 Copyright Qdossier B.V.
  • Controlled vocabulary 12/5/2013 Copyright Qdossier B.V.
  • Controlled vocabulary (Cont’d) “Working documents means draft versions of summary of product characteristics, package leaflet, and labeling editable by the Danish Health and Medicines Authority” QOS and (non-)Clinical overview? 12/5/2013 Copyright Qdossier B.V.
  • Errors in guidance <sequence number>-working documents „sequence number - workingdocuments’ (no hyphen) 12/5/2013 Copyright Qdossier B.V.
  • eCTD viewing
  • eCTD viewing beyond specifications.. Source: IRISS Life Cycle Group 2009 Source: IRISS Life Cycle Group 2009 12/5/2013 Copyright Qdossier B.V.
  • From multiple to single section Source: IRISS Life Cycle Group 2009 Source: IRISS Life Cycle Group 2009 12/5/2013 Copyright Qdossier B.V.
  • Shared documents across sections Source: IRISS Life Cycle Group 2009 12/5/2013 Copyright Qdossier B.V.
  • Viewing across products and countries 12/5/2013 Copyright Qdossier B.V.
  • eCTD: a rigid structure
  • Administrative information Regional administrative information = country specific information 12/5/2013 Copyright Qdossier B.V.
  • Administrative information Risk management plan: 1.3.8.2 Risk management plan 1.6.2 Risk management plan 1.8.2 Risk management plan 1.13 Risk management plan 1.16 Risk management plan 12/5/2013 Copyright Qdossier B.V. (CA) (GCC) (EU+CH) (ZA) (US)
  • eCTD today Envelope information + other metadata GMO Non-GMO Orphan PSMF RMP GMO 12/5/2013 RMP Copyright Qdossier B.V. RtQ
  • eCTD yesterday Envelope information + other metadata <cc> SmPC Agency codes EMEA = EMA DKMA = DHMA USKVBL AEMPS = ES-AEMPS Country codes AT - Austria BE - Belgium CZ - Czech Rep. DE - Germany DK - Denmark SmPC ES - Spain FI - Finland HR - Croatia 12/5/2013 Copyright Qdossier B.V.
  • eCTD day before yesterday Envelope information + other metadata GMO Non-GMO Orphan DSUR PSMF RMP GMO 12/5/2013 RMP Copyright Qdossier B.V. RtQ
  • XEVMPD/IDMP principles XSD schema defining structure CV Substance List of allowed substance names 12/5/2013 CV Substance Metadata List of allowed ATC codes ISO 3166-1 List of country codes Regional Implementation guideline Validation Copyright Qdossier B.V.
  • eCTD tomorrow? RMP Controlled CV List of Vocabulary allowed labels: List of allowed GMO Non-GMO labels (Agency DSUR controlled) RMP DSUR v1.0 12/5/2013 Copyright Qdossier B.V.
  • Allows easy updating of… Use of the European Agency Acronym Addition of Other PDF Versions Addition of Risk Management Plan as a New Submission Type Revisions Regarding Agency Names and Agency Codes Source: Release notes EU module 1 specification v2.0 12/5/2013 Copyright Qdossier B.V.
  • Concluding remarks Continuous education needed Agency focus moves from technical to non-technical aspects (Much) broader/ leaner technical specifications needed for structure Well specified implementation guidelines and controlled vocabulary to assure correct use Correct application assured by validation tools (Hopefully with some build in consistency checks) 12/5/2013 Copyright Qdossier B.V.
  • Thank you ! Michiel Stam Manager Regulatory Operations www.qdossier.com