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Expert Review Panel

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Title: Expert Review Panel


1
Expert Review Panel
Consultative Meeting of the Global Fund with
Manufacturers of ARVs, Anti-TB and Anti Malarial
Products 5 February 2009

2
Expert Review Panel
  • Background
  • Purposes and Process
  • The invitation for Expression of Interest
  • Importante dates

3
Background
  • At its 18th Meeting in November 2008, the Global
    Fund Board approved a revised Quality Assurance
    Policy for Pharmaceutical Products (QA Policy).
  • The QA Policy provides that Global Fund grant
    funds may only be used to procure
    antiretrovirals, anti-tuberculosis and
    anti-malarial finished pharmaceutical products
    (FPPs) that meet the following standards
  • Prequalified by the WHO Prequalification
    Programme or authorized for use by a Stringent
    Drug Regulatory Authority (SRA) or
  • Recommended for use by an Expert Review Panel
    (ERP).

4
The Expert Review Panel
  • An independent technical body
  • Hosted by WHO Department of Essential Medicines
    and Pharmaceutical Policies
  • Composed of external technical experts.
  • Purposes
  • To review the potential risks/benefits
    associated with the use of FPPs that are not yet
    WHO-prequalified or SRA-authorized.
  • To make recommendations to the Global Fund

5
Expert Review Panel (ERP) mechanism
  • Review at the request of the Global Fund, or
  • Submissions in response to GF invitation for EoI
    to submit dossiers.
  • A product is eligible for review by the ERP if
  • Application to WHO Prequalification or
    application for marketing authorization to an SRA
    is accepted, and
  • Manufacturing site GMP compliant
  • ERP will review each submission to determine
    whether the benefits of funding the product with
    Global Fund resources outweigh the potential
    quality risks.
  • Manufacturers will be notified of the outcome of
    the ERPs review.
  • ERP recommendations
  • Time limited recommendations (maximum 12 months)
  • Possibility of extending the recommendation
    period, under certain circumstances
  • Contracts to supply products based on a
    recommendation by the ERP may be concluded any
    time during the validity of the recommendation

6
The Global Fund Secretariat Responsibilities
  • to invite manufacturers of selected medicines to
    submit an Expression of Interest (EoI) to have
    FPPs reviewed by the ERP
  • to manage the receipt of product questionnaire
    dossiers sent by manufacturers according to the
    EoI
  • to provide complete product questionnaire and
    associated documents to the ERP Coordinator for
    review
  • to notify manufacturers of the outcome of the
    ERPs review of their respective FPP dossiers
  • to maintain on its website an up-to-date list of
    all FPPs that have been recommended for use by
    the ERP.

7
ERP Responsibilities
  • to review the potential risks/benefits associated
    with the use of FPPs that are not yet
    WHO-prequalified or SRA-authorized, through
    assessment of product dossiers with a particular
    focus on the technical information
  • to deliver to the Global Fund a report ,
    including recommendations and timeline, within
    the timeline agreed with the Global Fund.

8
Technical Areas of ERP review
  • Product questionnaire dossier
  • product registration information
  • regulatory (licensing) status of the FPP and
    manufacturing facility
  • finished product specifications and information
    regarding compliance with international
    pharmacopoeia standards, if available
  • stability testing data (both accelerated and real
    time studies) as per ICH and/or WHO Guidelines
  • product labelling information
  • active pharmaceutical ingredient (API)
    characteristics and certification and
  • safety and efficacy data for innovator products
    or human bioequivalence data for generic products.


9
Invitation for Expression of Interest (EoI)
  • Purpose to invite submissions for ARVS,
    first-line anti-tuberculosis, Anti Malarial
    products which are not yet WHO-prequalified or
    SRA-authorized, for review by the ERP
  • Main Goal to review in advance products which
    could be purchased by PR when only few
    prequalified products or SRA authorized product
    are available on the market
  • Published on our web site
  • http//www.theglobalfund.org/en/procurement/quali
    ty/?langen

10
Documentation submitted by Manufacturers for
ERP review
  • For each product awaiting WHO-prequalification or
    SRA authorization
  • A covering letter expressing interest to submit
    the product to the ERP for review
  • An acceptance letter from the WHO
    Prequalification Programme stating the WHO
    reference number assigned by WHO to this specific
    product, or
  • An acceptance letter from the SRA confirming
    that the submission for the product has been
    accepted for review
  • GMP status
  • A completed Pharmaceutical Product Questionnaire
    and all annexes as applicable
  • A non-returnable product sample as requested in
    Section VIII of the questionnaire
  • Documentation should be submitted in hard copy
    and electronically

11
Key Milestones
  • - 28 February 2009 deadline for submission to
    GF of documents for Anti-TB, Anti Malarial
    products ERP review
  • - 15 March 2009 deadline for submission to GF
    of documents for ARVs products ERP review
  • - 15 June 2009 GF list of Anti TB, Anti
    Malarial, ARVs published, including
    prequalified products, SRA authorized products,
    ERP recommended products

1st July 2009 the revised QA Policy becomes
effective Ci or Cii products classification is
no longer applicable. Only A, B or ERP
recommended products be purchased QA applicable
to all ARVs, Anti TB and Anti Malarial products
12
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