Quality assurance for essential medicines and health products. IPC meeting: December 2012

Transcription

1 Quality assurance for essential and health products IPC meeting: December 2012

2 Pharmaceutical Products QA Policy (June 2009) December 2010: requirements to purchase ACTs FDC in priority Condoms Procurement guidelines (WHO 2010) Diagnostic Products QA Policy (Dec 2010 ) Global Fund Quality Assurance for Health Products Long Lasting Insecticidal Nets WHOPES recommendations and specs 2

3 the Global Fund s QA policy (issued December 2010): Clinical Criteria Medicines must be listed in WHO or national or institutional Standard Treatment Guidelines (or appropriate technical justification) + Quality Criteria + All must be authorized for use in recipient countries + Additional stringent criteria for all ARVs, anti-tb products and antimalarials Quality Monitoring Grant recipients must organize: Monitoring quality all along the supply chain (storage, distribution) Systematic random quality control testing 3

4 Less Quality criteria for non ATM essential Category Antiretroviral, anti-tb, antimalarial (ATM) Other essential WHO-PQ: Prequalification Stringent Regulatory Authority (SRA) authorization Expert Review Panel (ERP): Time-limited advice (if <2 WHOprequalified or SRAauthorized) National Medicines Regulatory Authority (NMRA) authorization Procurement as per principles of WHO Model Quality Assurance System for procurement agencies 4

5 Pros and cons of QA approaches for non-atm essential Approach Advantages Challenges WHOprequalification (PQ) Stringent assessment & follow-up of issues in countries Limited capacity of WHO-PQP Cost - no incentives for manufacturers to reach and maintain PQ status Stringent regulatory auth. (SRA) approval Expert Review Panel risk assessment Regulatory approval in country of use Qualification of procurement agencies (PAs) Stringent assessment availability & competition of expertly QA d products Known, accepted approach Responsible authority Best placed for post-market surveillance Holistic approach to QA Involvement of PAs from recipient countries Cost no incentives for manufacturers operating in non-stringent environment Time-limited approval Less stringent when not linked to PQ / SRA approval Weak capacity and enforcement in most recipient countries Current diverse QA capacity Commercial entities conflict of interest? 5

6 A proposed risk-based approach Assessing entity / Approach : Risk level: High Medium Low WHO Prequalification Program HIV/AIDS, TB, Malaria ("ATM") Non-ATM on WHO-EOI list (for opportunistic infections & other) Expert Review Panel (hosted by WHO): Time-limited approval HIV/AIDS, TB, Malaria ("ATM") Could be extended to Non-ATM Stringent Regulatory Authority (SRA) approval HIV/AIDS, TB, Malaria ("ATM") Non-ATM Non-ATM Non-ATM National Medicines Regulatory Authority (NMRA) approval Capacity- building /cooperation Through WHO-Prequalification Programme / regional initiatives (e.g. Joint assessments) High-risk (to be defined) Through regional initiatives (e.g. qualification for minimum regulatory functions): Non-ATM Medium-risk (to be defined) Non-ATM Low-risk (to be defined) Procurement Entity Qualified by an independent body (need common standards) MQAS standards HIV/AIDS, TB, Malaria ("ATM") Non-ATM Non-ATM Non-ATM 6

7 Recommendations Donors and procurement agencies should work towards common quality requirements for non-atm WHO work on risk categorization of essential Towards qualification of Procurement Agencies WHO will host a website of completed and planned manufacturing site inspections, affiliation of lead inspector and contact details of person responsible for clarifications 7

8 Outline A model quality Assurance system for procurement agencies development of an harmonized tool 8

9 Assessment of procurement agencies based on MQAS Some partners already developed their own tool to assess procurement agencies capacity to comply with the MQAS Guidelines: Different interpretation of the MQAS by the partners Need for an harmonized tool for the assessment of procurement agencies, to be utilized by all with the aim of better use of resources by coordinating PA assessments and working towards mutual recognition of PA assessment findings Working group : QUAMED, PFSCM, UNICEF, MSF, IDA, Crown Agents, GDF, MSH, UNION, UNOPS, USAID, ICRC and CHMP The Global Fund Secretariat agreed to facilitate the work of the working group and appointed a consultant in December 2011 for developing the tool with the working group 9

10 Development of an Harmonized tool and MQAS review Q Step 1 Q Step 2 and 3 Q Steps 4 and 5 Q3 2012/ to Q Liaise with organizations of the working group Obtain the existing tools Review the information and tools provided Prepare a report on the organizations tools Review the MQAS and identify areas for amendments Organize meeting with the organizations to present the outcome of reviews: March Review each MQAS module, propose tool ( including scoring) collect participants comments Prepare an update of the MQAS with the recommendations for changes Organize a meeting to discuss the tool and the updated MQAS : June 2012 Formalize the tool, and submit comments on MQAS to WHO (Q3 2012) Pilot phase : each participant to use the common tool for a period of 6 months ( self assessment or external assessment) ( Q Q1 2013) Finalization of the tool based on comments received 10

11 Procurement of Quality Assured Diagnostics, Inter Agencies collaboration 11

12 Quality Assurance Policy for Diagnostic Products: Selection of quality products Clinical Criteria Product types must be selected in compliance with: National guidelines and WHO guidance A technical justification should be provided if included only in one of above Quality standards for manufacturing sites Quality standards for, Malaria and HIV RDTs, ELISA and WB ISO 13485: for All diagnostics Assessed according to requirements of authorities member of GHTF or Approved by WHO after technical assessment Genev a 12 12

13 Implementation : challenges (1) Few products prequalified/assessed by WHO No centralized information system available to identify products approved by authorities member of GHTF, except for USAID List of Approved HIV/AIDS Rapid Test Kits Challenges to follow upgrades of products Lack of standardization of products, (including nomenclature, packaging ). RBM PSM WG RDT harmonization initiative Difficulties to monitor the quality at country level Genev a 13 13

14 Implementation: challenges Lack of knowledge and capacity at country level in regulating diagnostics, and in procurement process Lack of sufficient guidance for quality monitoring, including quality control, at country level, adapted to programs/countries Multiplicity of stakeholders, at country level: too often lack of collaboration, need to reinforce communication among all stakeholders. Procurement policies for diagnostics Genev a 14 14

15 Pharmaceutical Products QA Policy (June 2009) December 2010: requirements to purchase ACTs FDC in priority Condoms Procurement guidelines (WHO 2010) Diagnostic Products QA Policy (Dec 2010 ) Global Fund Quality Assurance for Health Products Long Lasting Insecticidal Nets WHOPES recommendations and specs Insecticides for IRS 15