ERP mechanism

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ERP mechanism

  1. 1. Quality Assurance Policy for Pharmaceutical Products The Expert Review Panel mechanism
  2. 2. Outline <ul><li>Expert Review Panel </li></ul><ul><ul><li>Background </li></ul></ul><ul><ul><li>Mechanism </li></ul></ul><ul><ul><li>Responsibilities </li></ul></ul><ul><ul><li>Categorization of products reviewed by ERP </li></ul></ul>
  3. 3. Background <ul><li>At its 18th meeting in November 2008, the Global Fund Board approved a revised Quality Assurance Policy for Pharmaceutical Products (“QA Policy”). </li></ul><ul><li>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: </li></ul><ul><ul><li>FPP is prequalified by the WHO Prequalification Programme or authorized for use by a Stringent Drug Regulatory Authority (SRA) or </li></ul></ul><ul><ul><li>Permitted for time-limited use based on advice by an Expert Review Panel (ERP). </li></ul></ul>
  4. 4. The Expert Review Panel <ul><li>An independent technical body : TORs developed and approved by PC in March 2009 </li></ul><ul><li>Established and administered with guidance from WHO </li></ul><ul><li>Composed of external technical experts: representative of a wide range of expertise in the pharmaceutical and medical fields and preferably include at least two members with recent work experience in an SRA </li></ul><ul><li>Purposes: </li></ul><ul><ul><li>To review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA-authorized. </li></ul></ul><ul><ul><li>To advise the Global Fund in its decision on whether to allow grant funds to be used to procure FPP </li></ul></ul>
  5. 5. Expert Review Panel mechanism <ul><li>Review of product documentation: </li></ul><ul><ul><li>at the request of the Global Fund, or </li></ul></ul><ul><ul><li>in response to Global Fund invitation for EoI to submit dossiers. </li></ul></ul><ul><ul><li>(based on review of products listed in proposals and partner input) </li></ul></ul><ul><li>A product is eligible for review by the ERP if: </li></ul><ul><ul><ul><li>Criteria 1: an application to WHO Prequalification or application for marketing authorization to an SRA is accepted for assessment, and </li></ul></ul></ul><ul><ul><ul><li>Criteria 2: the manufacturing site is GMP compliant (SRA / WHO / PICs) </li></ul></ul></ul>In November 2009 the QA policy was amended to expand the above eligibility criteria for certain multi-source FPPs* for malaria and first-line tuberculosis treatment. These FPPs can be reviewed if they do not meet criteria under 1. above, but meet criteria under 2. above (GMP compliance). They are listed separately in the Global Fund’s invitations for Expression of Interest (EoI). For details on EoI see slide 7. * Multi-source FPPs: pharmaceutical products for which the monograph of the finished dosage form was published in the International, U.S. or U.K. Pharmacopeia before 10 October 2002
  6. 6. Expert Review Panel mechanism <ul><li>ERP will review each submission and advise Global Fund as to whether the benefits of procurement outweigh the potential quality risks. </li></ul><ul><li>Manufacturers will be notified of the outcome of the ERP’s review for product dossier(s) submitted. </li></ul><ul><li>Product eligible for procurement with grant funds (based on ERP advice) </li></ul><ul><ul><li>Time limited eligibility (maximum 12 months) or until the product is WHO-prequalified or SRA authorised, whichever is earlier. </li></ul></ul><ul><ul><li>Possibility of extending the period of eligibility, under certain circumstances up to an additional 12 months if product is not yet WHO prequalified or SRA authorised. </li></ul></ul><ul><li>Contracts to supply products may be concluded any time during the eligibility period </li></ul>
  7. 7. Invitation for Expression of Interest (EoI) <ul><li>Purpose : to invite submissions for ARVs, first-line anti-tuberculosis and antimalarial products which are not yet WHO-prequalified or SRA-authorized, for review by the ERP </li></ul><ul><li>Main Goal: to review in advance products which could be needed by PRs when no or few prequalified products or SRA authorized product are available on the market </li></ul><ul><li>The medicines listed in the EOI are : </li></ul><ul><ul><li>medicines selected in WHO/National treatment guidelines (as per the Global Fund QA policy requirements) </li></ul></ul><ul><ul><li>medicines for which less than 3 products currently WHO prequalified or SRA authorized (according to the information provided by the manufacturers) have been identified </li></ul></ul><ul><li>Published on the Global Fund web site: http://www.theglobalfund.org/en/procurement/quality/?lang=en </li></ul>
  8. 8. Documentation submitted by manufacturers for a review by ERP <ul><li>For each product in the process of WHO-prequalification or SRA authorization </li></ul><ul><ul><li>A covering letter expressing interest to submit the product to the ERP for review </li></ul></ul><ul><ul><li>A letter from the WHO Prequalification Programme stating the WHO reference number assigned by WHO to this specific product dossier and confirming acceptance of the dossier for assessment; or </li></ul></ul><ul><ul><li>An acceptance letter from the SRA confirming that the submission for the product has been accepted for review </li></ul></ul><ul><ul><li>GMP status </li></ul></ul><ul><ul><li>A completed Pharmaceutical Product Questionnaire and all annexes as applicable </li></ul></ul><ul><ul><li>A non-returnable product sample as requested in Section VIII of the questionnaire </li></ul></ul><ul><li>Documentation are submitted in hard copy and electronically </li></ul>
  9. 9. Global Fund Secretariat responsibilities <ul><li>The Global Fund QA Senior Officer </li></ul><ul><ul><li>prepare the invitations for EoI </li></ul></ul><ul><ul><li>manage the receipt of product questionnaire dossiers sent by manufacturers according to the EoI </li></ul></ul><ul><ul><li>provide complete product questionnaire and associated documents to the ERP Coordinator for review </li></ul></ul><ul><ul><li>notify manufacturers of the outcome of the ERP’s review of their respective FPP dossiers </li></ul></ul><ul><ul><li>maintain on the website an up-to-date list of FPPs eligible for procurement as per QA policy, based on ERP advice </li></ul></ul>
  10. 10. Categorization of products reviewed by ERP <ul><ul><li>Classification of products reviewed in four categories: </li></ul></ul><ul><ul><li>Products classified in Categories 1 and 2 may be considered for time-limited procurement. </li></ul></ul><ul><ul><li>Products classified in Category 3 may be considered for procurement only if there is no other option and the risk of not treating the disease is higher than the risk of using the product. </li></ul></ul><ul><ul><li>Products classified in Category 4 may not be considered for procurement under any circumstances. </li></ul></ul>
  11. 11. Category 1 Products The API is manufactured by a licensed site, and has acceptable specification. GMP certificate if available. Acceptable BE study (incl comparator) or multi-media dissolution data (for biowaiver- eligible products) have been submitted. The submitted data support the claimed shelf life or a minimum of 24 months shelf- life can be assigned (except for products which are inherently unstable ) The FPP is tested with verified compendial tests/methods and validated in-house tests /methods or is tested with acceptable in- house specification and validated test methods. The product is manufactured at SRA or WHO or PIC/S GMP compliant site Procurement of such product with Global Fund resources acceptable for a time limited period if less than 2 WHO PQ or SRA authorized products are available . Product can be listed on the GF website for a time limited period Product may be considered, for time-limited procurement The product is described by ALL OF the following: 1 Application of Global Fund QA Policy ERP advice Characteristics Category
  12. 12. Category 2 Products API is manufactured by licensed site (+GMP certificate, if available). The specification may not contain full set of tests and limits, but no major quality concern (e.g. residual solvents test for class III) . BE has been shown against a recommended comparator but source of the comparator is unknown or known to be outside of ICH, or comparator is itself a generic but prequalified by WHO or approved by SRA or PIC/S country . Stability data is submitted for a sufficient test period b ut test parameters (such as related substances and loss on drying) may not be complete . However the product is compendia and the related substances and limits of detection are not controlled in the monograph. The FPP is tested with verified compendia tests/methods (without additional in-house tests such as related substances, limits of detection and ICH class III residual solvents) Procurement of such product with Global Fund resources acceptable for a time limited period if less than 2 WHO PQ or SRA authorized products are available. Product can be listed on the Global Fund website for a time limited period only if there are less than 3 products, including products categorized in category 1, available. Product may be considered, for time - limited procurement The product is manufactured at SRA or WHO or PICs GMP compliant site 2 Application of Global Fund QA Policy ERP advice Characteristics Category
  13. 13. Category 3 Products Submitted stability data on one or two batches BE shown but the comparator product is not acceptable (i.e. not included in PQ comparator list or is a generic which is neither prequalified nor SRA approved). BE study not submitted for a product Not eligible for biowaiver, but multi- media dissolution data show similarity Acceptable in-house specification but analytical methods are not sufficiently validated Global Fund determines, in consultation with WHO and other relevant technical partners, if there is no other option, taking into account relevant factors such as country context, evidence of resistance etc. Procurement of such product with Global Fund resources may be permitted on an exceptional basis and for time-limited period only. To be considered on case by case basis. Because of the exceptional nature of this categorization and the likely conditionality on use, this product will not be listed in the website Product may be considered for procurement only if there is no other option and the risk of not treating the disease is higher than the risk of using the product. The product is manufactured at SRA or WHO or PICs GMP compliant site and is described by ANY OF the following; 3 Application of Global Fund QA Policy ERP advice Characteristics Category
  14. 14. Category 4 Products The API specification is not acceptable for critical test parameter Therapeutic equivalence not shown or BE study not acceptable/BE study data not submitted for a product not eligible for biowaiver. The current stability data are not satisfactory for products containing unstable APIs and does not allow any assignment of shelf life The specification/analytical validation is not acceptable for critical test parameter After verification, it is determined that t he product is not manufactured at WHO/SRA/ PICs GMP compliant site Procurement of such product not allowed with the Global Fund resources. Product not listed in the GF website Product may not be considered for procurement under any circumstances . The product is described by ANY OF the following: 4 Application of Global Fund QA Policy ERP advice Characteristics Category
  15. 15. ERP process (1)
  16. 16. ERP Process (2)

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