Global Fund List
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Global Fund List

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Global Fund List Global Fund List Presentation Transcript

  • The Global Fund List for ARV, TB and Malaria Kuala Lumpur, Malaysia, November 2009
  • Outline of the Session
    • Background
    • Global Fund Classification
      • Option “A”
      • Option “B”
      • Option “ERP Reviewed”
    • SRA and GMP
    • Procurement selection
    • Required Documentations for listing
    • 6. Comments/ Observation
  • Introduction
    • The list is an overview of pharmaceutical products subject to the Global Fund Quality Assurance Policy that are listed in National and/or WHO standard treatment guidelines ;
    • Products are classified according to the various options (A, B, and ERP reviewed) defined as per the Global Fund Quality Assurance Policy;
    • The list is developed as a tool to assist Principal Recipients (PR) to identify the status of finished pharmaceutical products (FPP;
    • The List is updated regularly (usually monthly), based on the information received by the Global Fund ;
    • The list is not “ Not Global Fund Approved List”
  • Product Classification
    • Option A - products are prequalified by the WHO Prequalification Programme;
    • Option B - products are approved or authorized for use by a Stringent Regulatory Authority (SRA) ;
    • Option ERP Reviewed - reviewed by Expert Review Panel (ERP) upon potential quality risk/benefit assessment of the product which are not yet WHO-prequalified or SRA-authorized.  
    • Permitted for time-limited ( 12 months) use based on advice by the ERP;
  • Stringent Regulatory Authority (SRA)
    • Members, Observers and Associates of ICH;
      • MEMBERS : European Union Members, Japan, United States;
      • OBSERVERS : European Free Trade Association (EFTA) represented by Swiss Medic of Switzerland, and Health Canada;
      • ASSOCIATES: through mutual recognition agreements- Australia, Norway, Iceland and Liechtenstein;
    • And any other entities which may be updated from time to time;
  • Good Manufacturing Practice (GMP)
    • Member countries of PIC/S;
      • Argentina (since January, 2008),
      • Austria, Belgium, Cyprus (since July, 2008), Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Malta (since January, 2008), Netherlands; Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden; Switzerland, United Kingdom;
      • South Africa (since July, 2007);
      • Malaysia, Singapore;
      • Australia , Canada;
  • Documentations Requirement
      • Option “ A ” :
          • WHO Prequalification Programme publishes the list of prequalified products which are considered as “ A” and updated accordingly in the GF List;
      • Option “B” :
          • Copy of approval, or registration certificate or marketing authorization from the Stringent Regulatory Authority ( SRA);
          • Copy of GMP (Good Manufacturing Practice) certificate issued by a member of ICH/PICs or WHO Prequalification;
      • ERP Reviewed :
          • Decision by GF Secretariat based on Advice from ERP upon review of product dossiers;
  • Product Selection
    • More than two A or B classified product;
    • Less than two A or B classified product;
    • ERP Reviewed product-
      • Notification
      • No Objection
      • QC testing
  • Temporary provision-20 th Board Decision, 2009
    • Only for certain multi source FPPs for Malaria & 1 st line TB;
    • Valid until only December 31, 2010 ;
    • No FPP classified as A or B or ERP reviewed available;
    • Manufactured at GMP compliant site;
    • Selected for procurement by relevant UN Agencies ;
    • Notification process- No Objection-QC testing;
  • QA Policy Compliance/Monitoring
    • Procurement Reporting by PR;
    • PQR database -Product information;
    • Monthly and Quarterly QA Compliance Report ;
      • Non Compliance Level 1
      • Non Compliance Level 2
  • Comment-Manufacturer
    • Always check the updated version of the GF List to make sure your qualified products are included;
    • Update the Secretariat right the way for any
      • new approval
      • modification of regulatory status;
      • change of manufacturing site;
    • Provide packaging information;
  • Global Fund List on the Web page
    • The Global Fund list for ARV, TB and Malaria is available on http://www.theglobalfund.org/en/procurement/list/?lang=en
    • We strongly encourage users to visit the webpage and make sure to use the most recent version when considering the procurement options.
    • For any questions or clarifications, please feel free to contact us at [email_address] ;
  • Global Fund List on the webpage
  • Questions
    • Terima kasih!!!!