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    E CTD Submission

    Uploaded by

    Lex
    The document discusses key aspects of the electronic Common Technical Document (eCTD) format for regulatory submissions. It describes the two main XML files that form the backbone and table of contents of an eCTD submission. It also outlines the different lifecycle operation attributes that can be applied to documents within an eCTD and explains some of the common terminology used in the eCTD language including modules, nodes, sequences and metadata. Finally, it provides a high-level overview of eCTD adoption among different regulatory regions.

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    E CTD Submission

    Uploaded by

    Lex
    57 views7 pages
    The document discusses key aspects of the electronic Common Technical Document (eCTD) format for regulatory submissions. It describes the two main XML files that form the backbone and table of contents of an eCTD submission. It also outlines the different lifecycle operation attributes that can be applied to documents within an eCTD and explains some of the common terminology used in the eCTD language including modules, nodes, sequences and metadata. Finally, it provides a high-level overview of eCTD adoption among different regulatory regions.

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    e CTD Submission

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    The document discusses key aspects of the electronic Common Technical Document (eCTD) format for regulatory submissions. It describes the two main XML files that form the backbone and table of contents of an eCTD submission. It also outlines the different lifecycle operation attributes that can be applied to documents within an eCTD and explains some of the common terminology used in the eCTD language including modules, nodes, sequences and metadata. Finally, it provides a high-level overview of eCTD adoption among different regulatory regions.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    57 views7 pages

    E CTD Submission

    Uploaded by

    Lex
    The document discusses key aspects of the electronic Common Technical Document (eCTD) format for regulatory submissions. It describes the two main XML files that form the backbone and table of contents of an eCTD submission. It also outlines the different lifecycle operation attributes that can be applied to documents within an eCTD and explains some of the common terminology used in the eCTD language including modules, nodes, sequences and metadata. Finally, it provides a high-level overview of eCTD adoption among different regulatory regions.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 7

    eCTD XML Files

     Each eCTD contains two XML files forming the Table of


    Contents, metadata about the submission, documents and
    structure of the eCTD

     index.xml backbone of Modules 2 to 5 located in nnnn folder (four


    digits), template defined by ICH
     Regional xml template is defined by region using ICH principles
     Regional template defines content including metadata
     located in the \nnnn\m1\xx\ folder (where xx is the two letter
    country/region code)
     xx-regional.xml can also contain ‘Envelope’ information providing
    further details about the submission

    22
    Lifecycle Operation Attributes

     All documents (leafs) in an eCTD must have a lifecycle


    operation
    Operation Meaning/Use
    new Used to identify a leaf that has never been submitted for this product
    before
    replace Used to replace a previous version of a leaf with a new version
    delete Used to hide from view a leaf that is no longer relevant to the review
    or was submitted in error
    append Used to associate a leaf with another leaf that has already been
    submitted
    Important Note: Append is generally recommended not to use
    (except for STF in the US) - Due to complications that this causes to
    the lifecycle management of the eCTD e.g. Can you append to an
    append & what if the document that was appended to is deleted?

    23
    Language of the eCTD
     XML (eXtensible Markup Language)
     A structured data exchange standard that is both human and machine readable
     Backbone
     Table of Contents in XML format
     Leaf
     Contains information about a document in the eCTD
     Will reference to a physical file on the file system
     Node
     A section in the eCTD e.g. 3.2.S.4.1
     Contains Leaf documents
     eCTD filename
     Physical filename linked to from contents page by including the file path (e.g.
    0000\m1\eu\10-cover\ema\ema-cover.pdf)
     Leaf title or eCTD title
     Document Name that will be displayed to the reviewer e.g. ‘Cover Letter’
     eCTD Sequence
     A four digit sequential number that identifies a particular submission e.g. 0000
    24
    Language of the eCTD
    • Lifecycle
    – Submission Lifecycle – Relationship between eCTD sequences using the Related
    Sequence metadata
    – Document Lifecycle – Relationship between document versions using Lifecycle operations
    (New, Replace, Delete & Append)
    • ICH eCTD Metadata
    – Information used to define the contents of submission sections e.g. indication, substance,
    manufacturer
    • Regional (m1) Metadata
    • Information in the XML that describes the submission
    • MD5 Checksum
    – Unique calculated value of a document used to determine if it has been changed
    • Baseline
    – Providing part or all of the current registered submission documents (normally as an initial
    eCTD sequence, but can be provided later in the lifecycle)
    – Many Health Authorities highly recommend baselines being provided, but industry position
    is that they should not be mandated
    • Current View
    – Displaying just those documents across all sequences that are current (i.e. not
    Deleted/Replaced)

    25
    Language of the eCTD
    • Regulatory Activity
    – A collection of eCTD sequences related to the same regulatory step
    e.g. A variation sequence and associated response sequences
    • Document Reuse
    – Ability to reference a document previously submitted by hypertext linking to it
    – Also can be possible to re-include documents in another section or another eCTD
    sequence or application without physically re-providing the file
    • STF (Study Tagging File)
    • Provides metadata to categorise study reports in Module 4 & 5 (required by US,
    encouraged in Canada)
    • Not allowed in Japan and not required by other HAs, but if included STF will be
    validated
    • Node Extension
    – Provides ability to create a node at the lowest level of the eCTD only, to help keep
    content together
    – Used in many regions as an alternative to STF
    • Schema/DTD
    – Provides rules on how the XML must be structured
    • Stylesheet
    • Used to display the eCTD XML in a user friendly manner
    26
    eCTD global map of
    activity

    27
    Visual of eCTD Adoption mid 2016

    Early eCTD adopters (Main ICH region) – Canada, Europe (CP), Japan, USA

    More recent eCTD adoption – Australia, Bahrain, Oman (2017), Saudi Arabia (2017), South Africa, Switzerland, Thailand, United Arab Emirates

    eCTD planned – Brazil, China, Egypt, Jordan, Kenya, Serbia, Singapore 28

    28

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