Expert Review Panel mechanism Consultative Meeting with Manufacturers of  ARVs , Anti-TB and Anti-Malarial Products 23rd –...
Global Fund  revised Quality Assurance policy  for Pharmaceuticals <ul><li>The Board approved the Quality Assurance Policy...
Outline <ul><li>Expert Review Panel </li></ul><ul><li>Background </li></ul><ul><li>Mechanism </li></ul><ul><li>Responsibil...
The Expert Review Panel <ul><li>An independent technical body :  </li></ul><ul><ul><li>TORs developed and approved by PC m...
  Expert Review Panel (ERP) mechanism <ul><li>Review  of product documentation: </li></ul><ul><ul><li>at the request of th...
Expert Review Panel (ERP) mechanism <ul><li>ERP  will review each submission and advise GF as to whether the benefits of p...
Invitation for Expression of Interest (EoI) <ul><li>Purpose :  to invite submissions for ARVS,  first-line anti-tuberculos...
Responsibilities <ul><li>The Global Fund Secretariat </li></ul><ul><li>ERP : </li></ul><ul><ul><li>The ERP coordinator </l...
The Global Fund Secretariat Responsibilities <ul><li>The GF QA officer  </li></ul><ul><ul><li>to manage the receipt of pro...
ERP Responsibilities <ul><li>The ERP coordinator  </li></ul><ul><ul><li>Manages the selection of ERP members according to ...
ERP members <ul><li>The nominated ERP members : the data for each FPP will be reviewed by two assessors </li></ul><ul><ul>...
  Technical Areas of ERP review <ul><li>Product  questionnaire dossier : </li></ul><ul><ul><li>product registration inform...
Categorization of products reviewed by ERP <ul><li>The following major product attributes will be used as a basis for comp...
Categorization of products reviewed by ERP <ul><ul><li>Products in  Categories 1 and 2   may be considered  for time-limit...
Category 1 Products Category Characteristics ERP  advice Application of  Global Fund  QA Policy 1 The product is described...
Category 2 Products Category Characteristics ERP  advice Application of  Global Fund  QA Policy   2 The product is manufac...
Category 3 Products Category Characteristics ERP  advice Application of  Global Fund  QA Policy 3 The product is manufactu...
Category 4 Products Category Characteristics ERP  advice Application of  Global Fund  QA Policy 4 The product is described...
Implementation of the revised QA Policy   Progress update <ul><li>Since  June 2009, 7  ERP products  have been either WHO ...
Implementation of the revised QA Policy   Progress update <ul><li>Second Invitation   to manufacturers of selected product...
Next Steps <ul><li>Preparation of the Third EoI to be published in December 2009 </li></ul><ul><li>Based on the Amendment ...
 
36  (36 % of total ARVs formulations) 4  (17% of total Anti-TB formulations) 3  (10% of total Antimalarial formulations) P...
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ERP mechanism Manufacturers meeting November 2009

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ERP mechanism Manufacturers meeting November 2009

  1. 1. Expert Review Panel mechanism Consultative Meeting with Manufacturers of ARVs , Anti-TB and Anti-Malarial Products 23rd – 25th November 2009, Kuala Lumpur, Malaysia
  2. 2. Global Fund revised Quality Assurance policy for Pharmaceuticals <ul><li>The Board approved the Quality Assurance Policy for Pharmaceutical Products (“QA Policy”) at its 18th Board, November 2008 </li></ul><ul><ul><ul><li>Standards </li></ul></ul></ul><ul><ul><ul><li>Option A: WHO prequalified </li></ul></ul></ul><ul><ul><ul><li>Option B: SRA authorized </li></ul></ul></ul><ul><ul><ul><li>Option ERP: Products reviewed by a panel of experts- the Expert Review Panel (ERP) </li></ul></ul></ul><ul><li>Expert Review Panel (ERP ) TORs were developed and approved by PC members in March 2009 </li></ul><ul><li>The QA Policy came into effect on 1 July 2009 </li></ul><ul><li>Amendment to this Policy adopted at the Global Fund at its 20 th Board , November 2009 </li></ul>
  3. 3. Outline <ul><li>Expert Review Panel </li></ul><ul><li>Background </li></ul><ul><li>Mechanism </li></ul><ul><li>Responsibilities </li></ul><ul><li>Categorization of ERP reviewed products </li></ul><ul><li>Implementation of the ERP </li></ul><ul><li>Problems encountered </li></ul>
  4. 4. The Expert Review Panel <ul><li>An independent technical body : </li></ul><ul><ul><li>TORs developed and approved by PC members in March 2009 </li></ul></ul><ul><ul><li>Established and administered with guidance from WHO for 2 years </li></ul></ul><ul><ul><li>Composed of external technical experts: </li></ul></ul><ul><ul><ul><li>representative of a wide range of expertise in the pharmaceutical and medical fields </li></ul></ul></ul><ul><ul><ul><li>two members, at least, with recent work experience in an SRA </li></ul></ul></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 (ERP) 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 GF invitation for EoI to submit dossiers. </li></ul></ul><ul><ul><li>(based on GF 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>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>Manufacturing site is GMP compliant (SRA / WHO/PICs) </li></ul></ul></ul><ul><li>* the criteria 1 can be omitted in specific circumstances </li></ul>
  6. 6. Expert Review Panel (ERP) mechanism <ul><li>ERP will review each submission and advise GF 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. </li></ul><ul><li>Product eligible for procurement with GF resources (based on ERP advice) </li></ul><ul><ul><li>Time limited eligibility (maximum 12 months) or until the product is WHO-prequalified or SRA authorized, 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 authorized. </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, Anti Malarial 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 purchased by PR when no or only 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>The EoI lists the documents to be submitted by Manufacturers for ERP review </li></ul><ul><li>Published on our web site: http:// www.theglobalfund.org/en/procurement/quality/?lang =en </li></ul>
  8. 8. Responsibilities <ul><li>The Global Fund Secretariat </li></ul><ul><li>ERP : </li></ul><ul><ul><li>The ERP coordinator </li></ul></ul><ul><ul><li>ERP members </li></ul></ul>
  9. 9. The Global Fund Secretariat Responsibilities <ul><li>The GF QA officer </li></ul><ul><ul><li>to manage the receipt of product questionnaire dossiers sent by manufacturers according to the EoI </li></ul></ul><ul><ul><li>to provide complete product questionnaire and associated documents to the ERP Coordinator for review </li></ul></ul><ul><ul><li>to notify manufacturers of the outcome of the ERP’s review of their respective FPP dossiers </li></ul></ul><ul><ul><li>to maintain on its website an up-to-date list of FPPs eligible for procurement as per GF QA policy, based on ERP advice </li></ul></ul>
  10. 10. ERP Responsibilities <ul><li>The ERP coordinator </li></ul><ul><ul><li>Manages the selection of ERP members according to the TORs published in the GF website </li></ul></ul><ul><ul><li>Ensures that ERP members remain current with latest WHO PQ and SRA guidelines </li></ul></ul><ul><ul><li>Arranges the timely  review of the dossiers received </li></ul></ul><ul><ul><li>Concludes - based on ERP members’ advice - regarding the acceptability or non-acceptability for procurement of each specific FPP according to a risk-assessment approach </li></ul></ul><ul><ul><li>Drafts the respective communications to the Global Fund and ensures timely delivery of the reports. </li></ul></ul><ul><li>  </li></ul>
  11. 11. ERP members <ul><li>The nominated ERP members : the data for each FPP will be reviewed by two assessors </li></ul><ul><ul><li>Evaluate the data provided in the submissions, </li></ul></ul><ul><ul><li>Draft the corresponding quality risk assessment reports, and allocate each product dossier to the appropriate risk category; </li></ul></ul><ul><ul><li>Advise the ERP coordinator which products can and which products cannot be considered as acceptable for time-limited procurement based on the evaluation of submitted data; </li></ul></ul>
  12. 12. Technical Areas of ERP review <ul><li>Product questionnaire dossier : </li></ul><ul><ul><li>product registration information; </li></ul></ul><ul><ul><li>regulatory (licensing) status of the FPP and manufacturing facility ; </li></ul></ul><ul><ul><li>finished product specifications and information regarding compliance with international pharmacopoeia standards, if available; </li></ul></ul><ul><ul><li>stability testing data (both accelerated and real time studies) as per ICH and/or WHO Guidelines; </li></ul></ul><ul><ul><li>product labelling information; </li></ul></ul><ul><ul><li>active pharmaceutical ingredient (API) characteristics and certification; and </li></ul></ul><ul><ul><li>safety and efficacy data for innovator products or human bioequivalence data for generic products . </li></ul></ul>
  13. 13. Categorization of products reviewed by ERP <ul><li>The following major product attributes will be used as a basis for comparing the products: </li></ul><ul><ul><ul><li>a. GMP status of the manufacturing site - one of the eligibility criteria for ERP review </li></ul></ul></ul><ul><ul><ul><li>b . FPP manufacturing process and FPP specification </li></ul></ul></ul><ul><ul><ul><li>c. Stability data </li></ul></ul></ul><ul><ul><ul><li>d. Evidence of therapeutic equivalence </li></ul></ul></ul><ul><ul><ul><li>e. API source and API quality </li></ul></ul></ul>
  14. 14. Categorization of products reviewed by ERP <ul><ul><li>Products in Categories 1 and 2 may be considered for time-limited procurement. </li></ul></ul><ul><ul><li>Category 3 may be considered for procurement in an exceptional basis 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 in Category 4 may not be considered for procurement under any circumstances. </li></ul></ul>
  15. 15. Category 1 Products Category Characteristics ERP advice Application of Global Fund QA Policy 1 The product is described by ALL OF the following: Product may be considered, for time-limited procurement 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 The product is manufactured at SRA or WHO or PICS GMP compliant site 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 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 ) Acceptable BE study (incl comparator) or multi-media dissolution data (for biowaiver- eligible products) have been submitted. The API is manufactured by a licensed site, and has acceptable specification. GMP certificate if available.
  16. 16. Category 2 Products Category Characteristics ERP advice Application of Global Fund QA Policy 2 The product is manufactured at SRA or WHO or PICs GMP compliant site Product may be considered, for time - limited procurement 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. 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) 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. 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 . 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) .
  17. 17. Category 3 Products Category Characteristics ERP advice Application of Global Fund QA Policy 3 The product is manufactured at SRA or WHO or PICs GMP compliant site and is described by ANY OF the following; 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. 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 Acceptable in-house specification but analytical methods are not sufficiently validated BE study not submitted for a product . Not eligible for biowaiver , but multi-media dissolution data show similarity . 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).
  18. 18. Category 4 Products Category Characteristics ERP advice Application of Global Fund QA Policy 4 The product is described by ANY OF the following: Product may not be considered for procurement under any circumstances . Procurement of such product not allowed with the Global Fund resources. Product not listed in the GF website After verification, it is determined that t he product is not manufactured at WHO/SRA/ PICs GMP compliant site The specification/analytical validation Is not acceptable for critical test parameter The current stability data are not satisfactory for products containing unstable APIs and does not allow any assignment of shelf life Therapeutic equivalence not shown or BE study not acceptable/BE study data not submitted for a product not eligible for biowaiver. The API specification is not acceptable for critical test parameter
  19. 19. Implementation of the revised QA Policy Progress update <ul><li>Since June 2009, 7 ERP products have been either WHO prequalified or SRA authorized </li></ul><ul><li>First Invitation to manufacturers of selected product formulations to submit product dossier for review by ERP for the three diseases </li></ul><ul><ul><li>Publication mid December 2008 </li></ul></ul><ul><ul><li>Deadline First week of April 2009 </li></ul></ul><ul><ul><li>ERP review meeting: fist week of May 2009 </li></ul></ul><ul><ul><li>Outcome of the ERP review sent to Manufactuers: mid June 2009 </li></ul></ul>Outcome of First ERP review Products dossier reviewed Permitted Products (time limited) Malaria 18 3 Tuberculosis 12 10 HIV 30 15
  20. 20. Implementation of the revised QA Policy Progress update <ul><li>Second Invitation to manufacturers of selected product formulations to submit product dossier for review by ERP for the three diseases </li></ul><ul><ul><li>Publication mid July 2009 </li></ul></ul><ul><ul><li>Deadline for dossier submission: mid September 2009 </li></ul></ul><ul><ul><li>ERP review meeting: first week of October 2009 </li></ul></ul><ul><ul><li>Outcome of the ERP review sent to Manufacturers: first week of </li></ul></ul><ul><ul><li>November 2009 </li></ul></ul>Outcome of First ERP review Products dossier reviewed Permitted Products (time limited) Malaria 8 0 Tuberculosis 3 1 HIV 4 0
  21. 21. Next Steps <ul><li>Preparation of the Third EoI to be published in December 2009 </li></ul><ul><li>Based on the Amendment of the QA policy, additional medicines will be listed : </li></ul><ul><ul><ul><li>Chloroquine </li></ul></ul></ul><ul><ul><ul><li>Primaquine </li></ul></ul></ul><ul><ul><ul><li>Quinine injectable products </li></ul></ul></ul><ul><ul><ul><li>Additional strengths of First line anti TB medicines </li></ul></ul></ul>
  22. 23. 36 (36 % of total ARVs formulations) 4 (17% of total Anti-TB formulations) 3 (10% of total Antimalarial formulations) Product formulations at least 3 FPPs WHO PQ or SRA authorized 12 8 3 Product formulations with ERP recommended product 14 3 0 Product formulations with 2 FPP WHO PQ or SRA authorized 34 9 12 Product formulations with 1 FPP WHO PQ or SRA authorized 13 13 % of total ARVs formulations 5 17 % of total Anti TB formulations 16 52% of total Anti-malarial formulations Product formulations with no FPP WHO PQ or SRA authorized ARVs formulations listed on GF list or on GF EoI for ARVs: 98 Anti-TB formulations listed on GF list or on GF EoI for anti-TB products: 23 Antimalarial formulations listed on GF list or on GF EoI for antimalarial products: 31  
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