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Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community

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Title: Slide 1 Last modified by: dell Created Date: 2/6/2006 8:44:20 AM Document presentation format: Custom Company: World Health Organization Other titles – PowerPoint PPT presentation

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Title: Training Workshop for Evaluators from National Medicines Regulatory Authorities in East African Community


1
Evaluation of Quality and Interchangeability of
Medicinal Products
Training Workshop for Evaluators from National
Medicines Regulatory Authorities in East African
Community Dar Es Salaam, Tanzania Date 10 to 14
September 2007
2
Evaluation of Quality and Interchangeability of
Medicinal Products
  • Overview of Dossier Requirements and Guidelines
  • Presenter Deus K. Mubangizi, pharmacist,
    MSc(Pharm.)
  • deuskm_at_yahoo.co.uk, dmubangizi_at_nda.or.ug
  • Chief Inspector of Drugs, National Drug
    Authority
  • WHO expert

3
Overview of Dossier Requirements and Guidelines
  • Outline of presentation
  • Objectives of presentation
  • Structure of dossier of medicinal products,
    information on the CTD format
  • Guideline on Submission of documentation for
    multisource FPPs
  • Supplement 1 (dissolution testing)
  • Supplement 2 (Extension of WHO list of stable
    compounds)
  • Products registered in ICH Region and related
    countries
  • Fixed-dose combinations
  • ICH guidelines
  • Variations

4
Overview of Dossier Requirements and Guidelines
  • Objective of the presentation
  • To give an overview of the dossier requirements
    and Guidelines used or referenced during the
    evaluation of dossiers under the WHO
    Prequalification Program
  • To demonstrate how the requirements and
    guidelines can be applied or used as reference
    during dossier evaluation

5

Data in the dossier should enable us to answer
the following questions
  • What is the product?
  • Is the quality presented acceptable on grounds
    of safety and efficacy?
  • Is the quality presented reproducible?
  • How long can the quality be maintained?
  • Quality must ensure consistency of safety and
    efficacy during the shelf life of all batches
    produced.

6
Overview of Dossier Requirements and Guidelines
(1)
  • Common Technical Document
  • (CTD)
  • An initiative under the ICH Europe, Japan and
    USA.
  • http//www.ich.org

7
Structure of dossier of medicinal products,
information on the CTD format (1)
  • A common format for the technical documentation
  • significantly reduces the time and resources
    needed to compile applications for registration
    of human pharmaceuticals
  • eases the preparation of electronic submissions
  • Facilitates regulatory reviews and communication
    with the applicant by a standard document of
    common elements
  • Simplifies exchange of regulatory information
    between Regulatory Authorities
  • This guideline is not intended to indicate what
    studies are required. It merely indicates an
    appropriate format for the data that have been
    acquired.

8
CTD format (2)
  • GENERAL PRINCIPLES
  • Text and tables should be prepared using margins
    that allow the document to be printed on A4
    paper.
  • The left-hand margin should be sufficiently large
    that information is not obscured by the method of
    binding.
  • Font sizes for text and tables should be easily
    legible, even after photocopying. Times New
    Roman, 12-point font, is recommended for
    narrative text.
  • Every page should be numbered.
  • Acronyms and abbreviations should be defined the
    first time they are used in each module.
  • References should be cited in accordance with the
    current edition of the Uniform Requirements for
    Manuscripts Submitted to Biomedical Journals,
    International Committee of Medical Journal
    Editors (ICMJE)1.

9
CTD format (3)
  • The CTD is organized into five modules
  • Module 1 is region specific.
  • Modules 2, 3, 4, and 5 are intended to be common
    for all regions.
  • Module 1. Administrative Information and
    Prescribing Information
  • Should contain documents specific to each region
    e.g. application forms or the proposed label for
    use in the region. The content and format of this
    module can be specified by the relevant
    regulatory authorities.
  • Module 1 Administrative Information and
    Prescribing Information
  • 1.1 Table of Contents of the Submission Including
    Module 1
  • 1.2 Documents Specific to Each Region (for
    example, application forms, prescribing
    information)

10
CTD format (4)
  • Module 2. Common Technical Document Summaries
  • Should begin with a general introduction to the
    pharmaceutical, including its pharmacological
    class, mode of action, and proposed clinical use.
    In general, the Introduction should not exceed
    one page.
  • Should contain 7 sections in the following order
  • 2.1 Common Technical Document Table of Contents
    (Modules 2-5)
  • 2.2 CTD Introduction
  • 2.3 Quality Overall Summary
  • 2.4 Non-clinical Overview
  • 2.5 Clinical Overview
  • 2.6 Non-clinical Written and Tabulated Summaries
  • Pharmacology
  • Pharmacokinetics
  • Toxicology
  • 2.7 Clinical Summary
  • Biopharmaceutical Studies and Associated
    Analytical Methods
  • Clinical Pharmacology Studies
  • Clinical Efficacy
  • Clinical Safety
  • Literature References
  • Synopses of Individual Studies

11
CTD format (5)
  • Module 3. Quality
  • Information on Quality should be presented in the
    structured format described in Guideline M4Q.
  • Module 3 Quality
  • 3.1 Table of Contents of Module 3
  • 3.2 Body of Data
  • 3.3 Literature References

12
CTD format (5)
  • Module 4. Non-clinical Study Reports
  • The non-clinical study reports should be
    presented in the order described in Guideline
    M4S.
  • Module 4 Non-clinical Study Reports
  • 4.1 Table of Contents of Module 4
  • 4.2 Study Reports
  • 4.3 Literature References

13
CTD format (6)
  • Module 5. Clinical Study Reports
  • The human study reports and related information
    should be presented in the order described in
    Guideline M4E.
  • Module 5 Clinical Study Reports
  • 5.1 Table of Contents of Module 5
  • 5.2 Tabular Listing of All Clinical Studies
  • 5.3 Clinical Study Reports
  • 5.4 Literature References

14
CTD format Overall Table of Contents (ToC)
15
CTD format Numbering System
16
CTD format Numbering System Module 2
17
CTD format Numbering System Module 2
18
CTD format Numbering System Module 3
19
CTD format Numbering System Module 4
20
CTD format Numbering System Module 5
21
Overview of Dossier Requirements and Guidelines
(2)
  • Guideline on Submission of documentation for
    Prequalification of Multi-source (Generic)
    Finished Pharmaceutical Products (FPPs) Used in
    the Treatment of HIV/AIDs, Malaria and
    Tuberculosis
  • http//mednet3.who.int/prequal

22
Generic Guide Definitions
  • Active Pharmaceutical Ingredient (API)
  • A substance or compound that is intended to be
    used in the manufacture of a pharmaceutical
    product as a therapeutically active compound
    (ingredient)
  • Pharmaceutical Product
  • Any preparation for human or veterinary use that
    is intended to modify or explore physiological
    systems or pathological states for the benefit of
    the recipient.
  • Finished Pharmaceutical Product (FPP)
  • A product that has undergone all stages of
    production, including packaging in its final
    container and labelling.

23
Multisource (Generic) product
  • Multisources are Pharmaceutically equivalent
    (WHO definition)
  • same amount of the same API
  • same dosage form
  • meet the same or comparable standards
  • intended to be administered by the same route
  • Multisources which are therapeutically equivalent
    are interchangeable

24
Quality of a Generic product
  • Multisource products must be of good quality and
    at least as safe and efficacious as existing
    products (WHO Manual, Blue Book, P. 29, chapter
    H., Interchangeability))

Equal quality with the comparator or a quality
shown and assessed to be as acceptable
Same Safety
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