Expert Review Panel

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

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Expert Review Panel

• Background
• Purposes and Process
• The invitation for Expression of Interest
• Importante dates

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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).

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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

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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

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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.

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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.

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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.

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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

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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

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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
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