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    Common Technical Document

    Uploaded by

    Siva Prasad
    The Common Technical Document (CTD) was developed through collaboration between regulatory agencies in Europe, the United States, and Japan. It establishes a common format for registration documents to facilitate simultaneous submission and review of technical data. The CTD structure divides content into modules, with Module 1 providing submission metadata and Modules 2 through 5 containing quality, nonclinical, clinical, and regional information respectively. An electronic CTD (eCTD) was later developed using XML formatting to allow electronic submission. Widespread adoption of the CTD has helped streamline the drug approval process internationally through greater harmonization.

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    © All Rights Reserved
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    Common Technical Document

    Uploaded by

    Siva Prasad
    38 views19 pages
    The Common Technical Document (CTD) was developed through collaboration between regulatory agencies in Europe, the United States, and Japan. It establishes a common format for registration documents to facilitate simultaneous submission and review of technical data. The CTD structure divides content into modules, with Module 1 providing submission metadata and Modules 2 through 5 containing quality, nonclinical, clinical, and regional information respectively. An electronic CTD (eCTD) was later developed using XML formatting to allow electronic submission. Widespread adoption of the CTD has helped streamline the drug approval process internationally through greater harmonization.

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    The Common Technical Document (CTD) was developed through collaboration between regulatory agencies in Europe, the United States, and Japan. It establishes a common format for registration documents to facilitate simultaneous submission and review of technical data. The CTD structure divides content into modules, with Module 1 providing submission metadata and Modules 2 through 5 containing quality, nonclinical, clinical, and regional information respectively. An electronic CTD (eCTD) was later developed using XML formatting to allow electronic submission. Widespread adoption of the CTD has helped streamline the drug approval process internationally through greater harmonization.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    38 views19 pages

    Common Technical Document

    Uploaded by

    Siva Prasad
    The Common Technical Document (CTD) was developed through collaboration between regulatory agencies in Europe, the United States, and Japan. It establishes a common format for registration documents to facilitate simultaneous submission and review of technical data. The CTD structure divides content into modules, with Module 1 providing submission metadata and Modules 2 through 5 containing quality, nonclinical, clinical, and regional information respectively. An electronic CTD (eCTD) was later developed using XML formatting to allow electronic submission. Widespread adoption of the CTD has helped streamline the drug approval process internationally through greater harmonization.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 19

    COMMON TECHNICAL DOCUMENT

    1 / 19
    ORIGIN OF CTD…

    ICH
    EWG

    WAS OFFICIALLY SIGNED

    OFF IN NOVEMBER 2000,

    AT 5TH ICH CONFERENCE;


    CTD
    CTD
    SAN DIEGO,CALIFORNIA.

    2 / 19
    CTD
    CTD
    CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES:

    1.European Medicines Agency (EMEA, Europe),

    2. Food and Drug Administration (FDA, USA) and

    3. Ministry of Health, Labour and Welfare


    (MHLW,Japan).

    CTD is maintained by ICH through EWG.

    It has been adopted by several other countries


    including Canada and Switzerland.

    3 / 19
     Any guideline which is given by ICH passes through different steps.
     These different steps are called STATUS of that GUIDELINE.

    Status of CTD
    STATUS FUNCTIONALITY
    STEP 4 STATUS ACHIEVED IN
    Step 1 Development of Consensus NOV.2000 IN 5TH ICH
    CONFERENCE IN SANDIEGO..
    Step 2 Text released for consultation
    STEP 5 STATUS ACHIEVED IN
    Step 3 Consultation outside ICH MAY.2001 IN ICH MEETING IN
    TOKYO.
    Step 4 ICH guideline finalized
    GUIDANCE MADE AVAILABLE
    Step 5 Implementation TO INDUSTRY IN OCTOBER
    16,2001 BY FDA.

    4 / 19
    SIGNIFICANCE OF CTD:
    Avoid generating and compiling different registration dossiers

    Common format will significantly reduce the time and resources

    Facilitates simultaneous submission in three regions

    Facilitates exchange of information among regulatory authorities

    Faster availability of new medicines.

    5 / 19
    STRUCTURE OF CTD:

    - Divided into various modules having


    different contents.

    6 / 19
    NOT A PART OF
    CTD
    MODULE 1
    1.REGIONAL INFO.
    1.1 ToC

    2.1 CTD ToC

    2.2 CTD INTRODUCTION PARTS OF CTD


    MODULE 2
    2.4 NCO Max. 30
    Max. 30 pgs. 2.5CO
    2.3
    QOS 2.6 NCWTS 2.7 CWTS
    100 - 150 pgs. 50 - 400 pgs.
    Max.40 or 80 pgs.

    MODULE 3 MODULE 4 MODULE 5

    3 Quality 4 non clinical study reports 5 clinical study reports


    3.1 ToC 4.1 ToC 5.1 ToC

    7 / 19
    Paper CTD eCTD

    c 1
    Do
    c 2 File 1 File 2
    Do
    c 3
    Do
    c 4
    Do
    File 3 File 4

    8 / 19
    eCTD:electronic CTD
    - Developed by M2 EWG (Multidisciplinary 2 Expert
    Working Group) of ICH.

    Industry <-----> Message <------> Agency

    Paper submission
    has been replaced
    by electronic
    submission

    9 / 19
    Characteristics of eCTD:-

    1. Files Referenced in the XML Backbone(s)


    (Extensible Markup Language)

    REASONS:

    1.It manages the large data for the entire submission


    and for each document within the submission.

    2.This XML backbone allows the eCTD submission to be


    viewed via a web browser and can be loaded on a Web
    server.
    10 / 19
    2.The file formats that can be included
    in the eCTD are Portable Document
    Format (PDF) and XML.

    However other formats can be used for


    graphs and images.
    JPEG
    PNG
    GIF
    -may be used for higher resolution.

    11 / 19
    3. All eCTD Submissions Include Module 1

    Module 1 Identifies following important information:


     Company Name
     Drug Name
     Submission Type
     Submission Date
     Application Number
     Sequence Number

    12 / 19
    Nomenclature for files and eCTD
    submission.
    EXAMPLE:- MODULE 2 FILE NOMENCLATURE AND eCTD submission

    Description File Name


    2.2 introduction 22-intro
    2.3 Quality overall summary 23-qos
    2.4 Non clinical Overview 24-nonclin-over
    2.5 Clinical Overview 25-clin-over
    2.6 Non clinical Written and 26-nonclin-sum
    Tabulated Summaries
    2.7 Clinical summary 27-clin-sum

    13 / 19
    Agency Sites with eCTD
    submission Information
    FDA : http://www.fda.gov/cder/regulatory/ersr/ectd.htm

    EMEA(EU) : http://esubmission.eudra.org/

    MHLW(JP) : http://www.mhlw.go.jp/english/index.html

    14 / 19
    Summary
    CTD was introduced with the aim to harmonize
    submission of technical data for registration of human
    use in different regions.

    After 5 years of implementation of ctd,we can say that


    considerable harmonization has been achieved in
    various regions for submission of technical data.

    More and more regulatory agencies have started


    association with this implementation generated actually
    by ICH before 5 years back.
    15 / 19
    FOR EXAMPLE :
    TGA (AUSTRALIAN REGULATORY AGENCY) has started
    submission of technical data in the form of CTD.

    http://www.tga.gov.au/docs/html/eugctd.htm
    http://www.tga.gov.au/docs/pdf/euguide/tgamod1.pdf
    http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2quality.pdf
    http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2safety.pdf
    http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2efficacy.pdf

    AND TGA IS NOW WORKING ON A PROJECT TO IMPLEMENT eCTD for


    marketing authorization, NDA, ANDA AND DIFFERENT DOSSIER
    SUBMISSION.

    16 / 19
    Study questions:
    1. What is CTD?
    What are the advantages of it?
    (uni. exam…2005)

    2. COMMENT ON:‘CTD is a common guideline for


    WHO,ICH,MCA,EMEA & USFDA.’
    (uni.exam…2006)

    3. What is CTD?
    Why it is introduced? Who regulates it?
    Give diagrammatic representation, advantages and
    exclusions of it. (uni. exam…2007)

    17 / 19
    REFERENCES:-
    www.ich.org
    http://www.fda.gov/cder/regulatory/ersr/ectd.htm
    http://esubmission.eudra.org/
    http://www.mhlw.go.jp/english/index.html
    http://www.tga.gov.au/docs/html/eugctd.htm

    18 / 19
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