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    Minor Variation Application

    Uploaded by

    William Chandra
    This document discusses minor variation applications for chemical drugs. It provides an overview of legal requirements for minor variations, categories of minor variations, an analysis of past minor variation applications, updates to the minor variation guideline, online submission through PRISM, and checklist requirements. The analysis found that most past applications were for administrative changes and CMC-related changes. The guideline was updated with items added and moved between categories. Online submission and checklist requirements are also outlined.

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    Minor Variation Application

    Uploaded by

    William Chandra
    21 views0 pages
    This document discusses minor variation applications for chemical drugs. It provides an overview of legal requirements for minor variations, categories of minor variations, an analysis of past minor variation applications, updates to the minor variation guideline, online submission through PRISM, and checklist requirements. The analysis found that most past applications were for administrative changes and CMC-related changes. The guideline was updated with items added and moved between categories. Online submission and checklist requirements are also outlined.

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    10_MinorVariationsMIVChemicalDrugs

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    This document discusses minor variation applications for chemical drugs. It provides an overview of legal requirements for minor variations, categories of minor variations, an analysis of past minor variation applications, updates to the minor variation guideline, online submission through PRISM, and checklist requirements. The analysis found that most past applications were for administrative changes and CMC-related changes. The guideline was updated with items added and moved between categories. Online submission and checklist requirements are also outlined.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    21 views0 pages

    Minor Variation Application

    Uploaded by

    William Chandra
    This document discusses minor variation applications for chemical drugs. It provides an overview of legal requirements for minor variations, categories of minor variations, an analysis of past minor variation applications, updates to the minor variation guideline, online submission through PRISM, and checklist requirements. The analysis found that most past applications were for administrative changes and CMC-related changes. The guideline was updated with items added and moved between categories. Online submission and checklist requirements are also outlined.

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    All Rights Reserved 2007 Health Sciences Authority | 1

    MINOR VARIATION APPLICATION


    MINOR VARIATION APPLICATION
    (CHEMICAL DRUGS
    (CHEMICAL DRUGS
    -
    -
    Appendix 9)
    Appendix 9)
    Dr Liu Yan Ping
    Deputy Head, Drug Registration Branch
    Product Evaluation & Registration Unit
    Centre for Drug Administration
    Health Products Regulation Group
    Health Sciences Authority
    16 J anuary 2007
    All Rights Reserved 2007 Health Sciences Authority | 2
    Overview
    Legal requirement
    Category of minor variation application
    Retrospective analysis of MIV-2
    application
    Update of minor variation guideline
    PRISM online submission
    Checklist
    All Rights Reserved 2007 Health Sciences Authority | 3
    Medicines (Licensing, Standard Provisions
    and Fees) Regulations
    First Schedule -
    Standard Provisions for Product Licence
    Product licence holder to inform licensing
    authority of changes in particulars contained
    in product licence application
    Legal Requirement
    All Rights Reserved 2007 Health Sciences Authority | 4
    MIV-1
    Regulatory approval is required
    MIV-2
    Regulatory approval is not required
    Changes that are not likely to affect the
    safety, efficacy and quality of product
    Notify HSA at least two months prior to
    actual implementation
    Category of Minor Variation (1)
    All Rights Reserved 2007 Health Sciences Authority | 5
    NOT MIV-2
    A result of unexpected events
    Due to stability concerns
    Conditions, documentations required in
    MIV-2 not met
    Category of Minor Variation (2)
    All Rights Reserved 2007 Health Sciences Authority | 6
    J an to Oct 2006 (chemical drugs and
    biologics): about 1100 applications
    Administrative changes
    CMC related changes
    Analysis of MIV-2 Application (1)
    All Rights Reserved 2007 Health Sciences Authority | 7
    62%
    4%
    34%
    Admin
    Admin+CMC
    CMC
    Analysis of MIV-2 Application (2)
    All Rights Reserved 2007 Health Sciences Authority | 8
    49%
    51%
    Clarification
    Non-clarification
    Analysis of MIV-2 Application (3)
    Admin related notification_Clarification
    All Rights Reserved 2007 Health Sciences Authority | 9
    12%
    88%
    Valid
    Non-valid
    Analysis of MIV-2 Application (5)
    Admin related notification
    All Rights Reserved 2007 Health Sciences Authority | 10
    63%
    37%
    Query
    Non-query
    Analysis of MIV-2 Application (4)
    CMC related notification_Clarification
    All Rights Reserved 2007 Health Sciences Authority | 11
    CMC related notification
    23%
    77%
    Valid
    Non-valid
    Analysis of MIV-2 Application (5)
    All Rights Reserved 2007 Health Sciences Authority | 12
    Items removed from the guideline
    Name of the product licence holder
    Address of the product licence holder
    Update of MIV Guideline (1)
    All Rights Reserved 2007 Health Sciences Authority | 13
    New items included for MIV-2
    Product name
    Batch numbering system
    Batch size of drug substance
    Batch releaser
    Test procedure for an excipient
    Safety update
    Update of MIV Guideline (2)
    All Rights Reserved 2007 Health Sciences Authority | 14
    Items revised from MIV-1 to MIV-2
    Secondary packager
    Test procedure of the medicinal product
    Item revised from MIV-2 to MIV-1
    Manufacturer of active drug
    substance
    Update of MIV Guideline (3)
    All Rights Reserved 2007 Health Sciences Authority | 15
    Section 0.4 Amendment Details
    MAV/MIV:Table of Summary of
    Changes
    PRISM Submission
    CTD E-copy Hardcopy
    Module 1/ Part 1 Yes 1 set
    Module 3/ Part 2 Optional 1 set
    Module 5/ Part 4 Yes Optional
    All Rights Reserved 2007 Health Sciences Authority | 16
    SIN99999P
    20/01/1995
    20/01/2007
    1.
    1. Addition of manufacturer for drug substance;
    2. Update of PRISM information:
    1) Storage condition
    2) Batch release details
    All Rights Reserved 2007 Health Sciences Authority | 17
    A. MAV/MIV: Table of Summary of Changes
    Section in Original
    Dossier Affected by
    Change
    Present Proposed Reason for change Status of proposed
    change in other countries
    i.e. whether approved,
    pending decision or
    rejected
    Status
    date (MAV-
    1 onl y)
    Part II Section S ABC Pharmaceuticals
    Address 1
    Country 1
    ABC Pharmaceuticals
    Address 1
    Country 1
    XYZ Pharmaceuticals
    Inc
    234 Halewood Drive
    East Sunset
    UK
    To provide alternative
    manufacturing source
    COO: UK approved
    Country A and Country B:
    approved.
    PRISM 4.7.4 From 23 to 30C Store below 30C Update PRISM
    information, approved by
    DRB on 22/12/2004
    NA
    PRISM 6. Not recorded XYZ Pharmaceuticals
    Inc
    789 Quality Drive
    London Highway
    UK
    Update PRISM
    information
    NA
    Specify the precise present and proposed wording or specification. For changes to package insert or Patient Information Leafl et, please highlight changes in the proposed version
    DETAILS OF VARIATION TO EXISTING PRODUCT LICENCE
    All Rights Reserved 2007 Health Sciences Authority | 18
    All Rights Reserved 2007 Health Sciences Authority | 19
    All Rights Reserved 2007 Health Sciences Authority | 20
    New requirement
    1. Compulsory documentations:
    Online application form, Section 0.4
    Amendment Details
    MAV/MIV:Table of Summary of Changes
    2. Copy of the dossier of relevant changes
    3. Declaration of the applicant
    Checklist
    All Rights Reserved 2007 Health Sciences Authority | 21
    Note
    All changes are fully disclosed in the
    Amendment Details
    All MIV application to be
    accompanied by the checklist
    All Rights Reserved 2007 Health Sciences Authority | 22
    THANK YOU

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