WHO support and Technical Assistance _ In-Vitro Diagnostics

Transcription

1 WHO support and Technical Assistance _ In-Vitro Diagnostics Joint UNICEF, UNFPA & WHO Meeting with Manufacturers and suppliers UN City, Copenhagen, Denmark September 2018 Dr Gaby Vercauteren Senior Adviser, Regulatory Systems Strengthening Team Regulation of Medicines and other Health Technologies Copenhagen, Denmark September

2 Outline The context Eligibility for technical assistance Principles & priorities for technical assistance Types of technical assistance and some data Past & future activities Copenhagen, Denmark September

3 The context Every year, hundreds of millions of US dollars worth of IVDs and medicines are purchased for distribution in resource-limited countries IVDs play a critical role in ensuring blood safety, surveillance, diagnosis and treatment initiation and monitoring IVDs save lives, reduce suffering and improve health, but only when they are of good quality, safe, effective, available, affordable, acceptable and properly used Copenhagen, Denmark September

4 WHO Prequalification access to the global market Prequalification listing linked to UN agencies procurement (WHO, UNICEF, UNDP, UNFPA) The Global Fund QA policy MSF Strong collaboration with USG (USAID, CDC) National procurement / tendering specs Range of products from which procurers can select Copenhagen, Denmark September

5 Prequalification scope HIV HCV HPV G6PD Cholera Syphilis malaria HBV PQ eligibility consultation SAGE-IVD Expansion of PQDx scope over time

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7 Changing IVDs global market trends Globalised industry sectors with outsourced production Rapid emergence of new technologies Increasing expectations on quality, safety and performance Increasing pressure on human resources and increased workload for regulators Easy to operate tests/methods facilitate near patient testing, hard-to-reach populations, non-lab environments Copenhagen, Denmark September

8 PQ in a regulatory framework Pre-market Changes Post-market perfor mance quality safety perfor mance quality safety Pre reliance Post-2014

9 WHO PQDx regulatory framework ISO and EN standards GHTF / IMDRF guidance documents CLSI guidance documents PQ requirements Copenhagen, Denmark September

10 Prequalification: decision Final prequalification outcome depends on: Results of dossier assessment and acceptance of action plan Results of inspection(s) and acceptance of action plan No level 5 nonconformities outstanding for either dossier or for inspection Meeting the acceptance criteria for the laboratory evaluation WHO PQDx Public Report is posted on WHO website and product is added to the list of WHO prequalified products Product is then eligible for WHO and UN procurement

11 What does PQ do differently to GHTF/IMDRF Requirements are based on the same set of standards PQ is aligned with internationally accepted practice BUT Assess products' regulatory versions intended for the global market Where a stringently reviewed versions exist, they are often not supplied to the global market RoW versions differ from stringently assessed version in Mx site, QC, labelling, key suppliers, composition, intended use etc. Review aspects of particular relevance for resource-limited settings Risk assessment, stability, flex studies, labelling, training and support network Take into account environment and user skills

12 What do we mean to regulate? TESTS TESTING????? POTENTIAL POINTS OF REGULATION

13 Background_ Rationale Lessons from PQDx Dossier submissions are improving, some still substandard Unclear product identification Instruction for Use not conform requirements Insufficient control over key suppliers Quality control of lots Stability testing Performance studies Lack of evidence of performance in the intended use setting Copenhagen, Denmark September

14 Background_ Rationale Lessons from PQDx A portion of inspections have shown critical nonconformities Ineffective quality management system Unsuitable facilities Lack of/ insufficient quality control of key product components Traceability issues; from raw materials to lot release Inadequate documentation and procedures to verify QC for lot release Inadequate procedures to handle customer complaints Copenhagen, Denmark September

15 Background_ Rationale Lessons from PQDx Lab evaluations Instructions for use_ often poor interpretation of results and reading times HIV RDTs lot to lot variation generally OK Customer service_ product identification Alerts_ Recalls Manufacturers may not be well prepared to act Retained samples for a case of complaint " product failure" Improve streams between_ user_ procurer _ Mx Copenhagen, Denmark September

16 Background_ Rationale Lessons from Mapping regulatory capacity for medical devices _including IVDs Regulation of IVDs is weak or lacking in many countries Africa, Asia, Recipient countries Countries with substantial manufacturing of UN priority IVDs Several countries have or are in the process of putting regulations for medical devices in place i.e. South Africa, other African countries, India P.R. China is converging towards IMDRF guidance Copenhagen, Denmark September

17 What do we want from you? Manufacturers - IVDs of assured quality within the PQ scope to be prequalified - Investment in innovative IVDs adapted to LMIC countries National regulatory authorities - Implementation of regulation of IVDs aligned with IMDRF - Pre- market - Post market - So that in future WHO PQ and countries in the region can rely on work that has been done satisfactory and avoid duplication. Copenhagen, Denmark September

18 Priorities for support & technical assistance Manufacturers/ Innovators of IVDs that are a priority and few products have been PQ-ed Mx of priority IVDs that have potential, but previous submission(s) to PQDx failed. Mx in stringently regulated countries_ products for the Global market Regulators/ Inspectorates / Notified bodies Countries with major production of IVDs for the global market China, India, Korea Recipient Countries starting regulation of IVDs Copenhagen, Denmark September

19 What can we do for you? Copenhagen, Denmark September

20 What is the type of technical support that we provide? RSS advisory visits to manufacturers - Gap analysis, assessement of readiness for PQ RSS trainings for manufacturers - Topic specific trainings RSS trainings for NRAs - Topic or function specific trainings Copenhagen, Denmark September

21 RSS technical assistance Analytespecific issues The QMS, regulation and certification PQDx requirements Research and development Copenhagen, Denmark September

22 Types of technical assistance Communication and advisory visits Gap analysis _innovators Useful Tools Sample dossier_ e.g. CD4 Training packages Guidance documents Tailor made TA to Mx on specific technical issues Training on general aspects and commonly observed technical issues Copenhagen, Denmark September

23 PQDx technical guidance documents > Product dossier: > 3 sample dossiers (VL, EID and HIVST) > several guidance documents to support dossier submissions > TGS1 Reference documents > TGS2 Stability studies > TGS3 Principles for performance studies > TGS4 Sample dossiers > TGS5 Product specific guidance > TGS6 IFU > TGS7 Flex studies > TGS8 Specimen types > TGS9 Test method validation > IMDRF ToC (more granularity than STED) > Inspections: > guidance documents > TGS10 Quality control principles > TGS11 Outsourcing and supplier mgt Technical assistance: workshops complemen ting guidance (training materials, case studies) Set of guidance documents and training sessions to assist manufactur ers

24 Overview of diagnostics-related Technical Assistance and Laboratory services trainings Date June _ am October Activity Advocacy meeting_ prequalification of Diagnostics, the importance of quality 9-11 June PQDx training Indian manufacturers Risk management and quality control for in-vitro diagnostics NIFDC-WHO meeting PQ regulatory requirements and stability studies Topics Main stakeholders meetings, manufacturers association, NACO, Un agencies representatives, CDSCO Major institutions PQDx observed non-conformities, detailed overview of risk management, risk analysis, risk report, risk mitigation, quality control of intermediate and final products Commonly observed short comings in study design, analytical and clinical and stability studies, lot release testing, repositories, focus on HIV, Hepatitis B &C. Number trained am June Advocacy meeting, Different Ministries and government officials, CDSCO, industry association pm-16 June September Workshop for Indian manufacturers: Regulatory requirements for performance & stability studies for in-vitro diagnostic medical devices PQDx training Chinese manufacturers Risk management and quality control for in-vitro diagnostics Commonly observed short comings in study design, analytical and clinical and stability studies, lot release testing, repositories, focus on HIV, Hepatitis B &C. PQDx observed non-conformities, detailed overview of risk management, risk analysis, risk report, risk mitigation, quality control of intermediate and final products December Joint CFDA-WHO meeting.dossier assessment of IVDs Exchange of information of processes and procedures, review and comparison of regulatory approaches August WHO training CDSCO Overview of PQ processes and procedures, dossier assessment, inspections and laboratory evaluations, Post market surveillance October December February WHO meeting for Chinese manufacturers on regulatory requirements for performance & stability studies of malaria rapid diagnostic tests (IVD) Joint CFDA/ WHO meeting : Dossier assessment of IVDs India Pharma and Medical devices Forum. Detailed overview of PQ requirements for malaria RDTs, GTS and TSS documents, dossier requirements, inspections, analytical and clinical performance, requirements, Post market surveillance. participation of BMGF, China Update on PQ processes and procedures, and new TSS documents dossier assessment, inspections and new ISO 1348:2016 aspects post market surveillance Advocacy and technical information sharing on prequalification of diag-nostics and implementation of the new rules. Presenting at the meeting and participating in several panel discussions and side events June 2nd Forum on China Biological Diagnostics Presentation on Prequalification of diagnostics and global market requirements August WHO-CFDI training for inspectors PQ approaches to inspection, rating of non-conformities, inspection reports, corrective action plans December WHO training CDSCO, inspectors PQ approaches to inspection, rating of non-conformities, inspection reports, corrective action plans Planned

25 Expected outcomes Improved quality & safety of products Product better responding to the needs of the global market Positive spin off effect on all products manufactured, at a site and/or by a company More efficient prequalification process: shorter timelines & higher success rate Improved regulatory capacity in key countries Thus : More quality diagnostics available and accessible to improve the health of people in low- and middle-income countries Copenhagen, Denmark September

26 Future plans To continue the activities, but also further expand involvement of third parties. To involve more local players to expand the reach out to local manufacturers India and P.R. China To foster regional regulatory networks for IVDs To build trust with PQDx and amongst each other Mapping of specific training needs for NRAs and affiliated Institutions Copenhagen, Denmark September

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28 Questions Copenhagen, Denmark September