Global Fund List


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Global Fund List

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