(Pan African Harmonisation Party) Learnings

Transcription

1 (Pan African Harmonisation Party) Learnings Patience Dabula 03 Dec 2015 SAMED Medical Device and IVD Regulatory Conference

2 Overview (Update and benefits of regulatory harmonisation of medical devices and IVDs for member countries) Pan African Harmonization Working Party background Rationale for Harmonization International Regulation Harmonisation Activities to date Harmonised agreements and way forward 2

3 PAHWP Background PAHWP is a voluntary body that aims to improve access to safe and affordable medical devices and diagnostics in Africa though harmonized regulation Current priority is in vitro diagnostic devices PAHWP started in a meetings with relevant stakeholders in Nairobi in July 2012; The formation of PAHWP was announced at the African Society for Laboratory Medicine (ASLM) Conference on 3rd December 2012 in Cape Town Representations from: Industry: Countries: Partners: 3

4 PAHWP Background Valuable, quality assured, safe medical devices and diagnostics are made available where needed To protect public health To study and recommend ways to Harmonize medical devices and diagnostics regulation in Africa TWG: IVD Regulatory Framework PAHWP TWG: Clinical Performance Studies TWG: Post-Market Surveillance 4

5 Rationale for harmonization Why harmonization? Duplication in facility inspections and clinical trials or clinical studies results in increased costs, making products less affordable. Approval processes in some countries are lengthy and??not transparent, leads to costly delay in patient access Costly and lengthy regulatory approval are significant disincentive to innovation

6 Rationale for harmonization Why now? Substantial investment in point-of-care diagnostics due to the recognition that inequity of access to diagnostics is a barrier to public health. Rapid technological advances such as nanotechnology, microarrays is driving innovation Recognition that regulatory barriers can stifle innovation Favourable environment for harmonization, e.g. harmonization for registration of medicines in EAC, Asia Harmonization Working Party (AHWP), ALADDIV etc

7 International Harmonisation Global Harmonization Task Force (GHTF) was formed following a need for Harmonisation The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence Members: Different Countries Official Observers Affiliate Organizations 7

8 Asian Harmonization Working Party (AHWP) Its goals are to study and Recommend ways to Harmonize Medical Device regulations in the Asian and Other regions for establishing Harmonized requirements, procedures and standards. Source: imdrf.org/ 18/10/2015 8

9 ALADDIV The Latin American Alliance for the Development of the in Vitro Diagnostics Created in 2012 Members: 12 Countries Organization acting in the whole Latin American region: Academy Industry (Associations) Healthcare Professionals (Associations) Public Laboratories (Government) Private Laboratories (Associations) It should reflect the complexity of the IVD productive chain, searching to share the best practices in the whole continent 9

10 PAHWP Meeting Representations Representations from: Industry: SALDA, SAMED, Abbott, Alere, Beckman, Becton Dickinson, DiaSep, Daktari, Mbio Diagnostics, Roche, Separation scientific Countries: Burkina Faso, Burundi, Ethiopia, Ghana, Kenya, Malawi, Mozambique, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Uganda, United Republic of Tanzania, Togo, Zambia, Zanzibar and Zimbabwe Partners including: London School of Hygiene and Tropical Medicine, (LSHTM) German International Co-operation (EAC-GIZ), the African Society for Laboratory Medicine (ASLM) and the World Health Organisation (WHO-AFRO, WHO-HQ).

11 DONE: Regulatory Harmonization Activities 2012: Mar: East African Community (EAC) Medicines Harmonization meeting Apr: Latin American Alliance for IVDs workshop May: African Society for Laboratory Medicine POC Diagnostics Meeting July: EAC meeting to set up PAHWP Oct: EAC-GIZ regulatory survey validation Nov: Latin American Association for IVDs workshop Dec: AHWP 17 th Annual meeting & PAHWP launch at ASLM Conference 2013: May: AHWP IVD Working Group Workshop Apr: EAC Regional Task Force meeting July: 1st African Regulatory Forum for Medical Diagnostics Sep: Inter-regional workshop convened by AHWP Oct: Latin American Association for IVDs Nov: ISO TC 212: ISO standard for IVD clinical performance studies Dec: AHWP 18 th Annual meeting 2014: Jan: 2 nd African Regulatory Forum for Medical Diagnostics Oct: Workshop with African manufacturers Nov: AHWP 19 th Annual Meeting Nov: ALADDIV (ANVISA) and PAHWP regulatory forum Dec: 3 rd African Regulatory Forum for Medical Diagnostics 2015: Update on Website Countries working on individual activities from Dec 2014 Mar: PAHWP - SAMED Meeting for workshop Mar: The 4 th African Medicines Regulatory Harmonization Advisory Committee May: Development and distribution of information sheet and application forms for membership Jun date: Forms received and meetings

12 DONE: Key PAHWP Meetings held Meetings held using funding from a grant from Grand Challenges Canada to the LSHTM the following meeting were held: 1st African Regulatory Forum on Medical Diagnostics held Jul 2013 (Nairobi) Joint workshop with Asian Harmonization Working Party sub group on in vitro diagnostics held Sep 2013 (Taiwan) 2nd African Regulatory Forum on Medical Diagnostics held Jan 2014 (Cape Town) Workshop: Basic IVD evaluation workshop, Arusha, Tanzania, Jul 2014 Workshop: policy framework and strategic plan for local production of in vitro diagnostics in developing countries Oct rd African Regulatory Forum on Medical Diagnostics -Nov 2014 (Cape Town)

13 Training workshops

14 3 rd African Regulatory Forum on Medical Diagnostics Recommendations The PAHWP confirmed its commitment to working with the African Union NEPAD and recommends a steering committee be established consisting heads of National Regulatory Authorities and National Laboratories. The PAHWP, coordinated by the AU-NEPAD Agency, welcomes the Diagnostics Access Initiative, and will work in partnership with partner states, WHO, LSHTM, ASLM and other partners to support harmonized regulatory guidance to ensure the quality of diagnostics.

15 3 rd African Regulatory Forum on Medical Diagnostics Recommendations PAHWP will establish a Resource and Learning Centre to promote pooling and sharing of resources and capacity building through e-learning from a virtual campus. PAHWP recommends countries adopt a stepwise approach to harmonised regulation of medical devices and in vitro diagnostics and urges countries to identify 1-3 priority areas for implementation in PAHWP requests that AU NEPAD convenes a meeting of the heads of African national regulatory bodies for medical devices and IVD diagnostics

16 EAC Process: Sectoral Committee, Council of Ministers, Summit PAHWP is hosted within the African Union-NEPAD Planning and Coordinating Agency African Regulatory Harmonization Advisory Committee for medicines, medical devices & diagnostics May : EAC approved 3 antimalarials & 2 health products Pan African Harmonization Working Party for Medical Devices & Diagnostics African Medicines Regulatory Harmonization (AMRH) TWG Medicines Policy & Regulatory Reforms African Medicines Regulatory Harmonization(AMRH) TWG on Regulatory Capacity Development TWG: IVD Regulatory Framework TWG: Clinical Performance Studies TWG: Post-Market Surveillance Subgroups Subgroups...

17 Five Priority Focus Areas for Regulatory Harmonization for PAHWP and their Impact Regulation Harmonization Priorities Results Impact Risk Classification Registration File Clinical Performance Studies Quality System Audits A common risk classification system adoption of the GHTF system A common dossier template -Adoption of the WHO PQ dossier Joint review of data from clinical performance studies Convergence of standards and 3rd party recognition of audits (MDSAP) More streamlined regulatory process Duplication in clinical performance studies and audits reduced Companies save time and money More affordable IVDs Faster access to quality-assured diagnostics Better patient outcomes Supports innovation Post- Marketing Surveillance Regional laboratory networks to monitor test quality Assurance of diagnostic quality More public confidence in diagnosis

18 Risk-based Approach to Regulation of IVDs Table 1 CLASS RISK LEVEL EXAMPLES A B C D Low Individual Risk and Low Public Health Risk Moderate Individual Risk and/or Low Public Health Risk High Individual Risk and/or Moderate Public Health Risk High Individual Risk and High Public Health Risk 1 A Model Regulatory Program For Medical Devices: An International Guide. WHO, GHTF/SG1/N45:2008 Principles of In Vitro Diagnostic Medical Devices Classification Stains, culture reagents Home use pregancy tests, Urine test strips Rapid tests for rubella, malaria Blood screening tests: HIV, HBV, HCV, HTLV

19 Risk Classification of IVDs: WHO 2014 Table of Contents: 1. Introduction 2. Intended Audience and Scope 3. Definitions 4. Abbreviations 5. Risk Classification 6. Assessing IVDs Critical Elements 7. Performance Evaluations and Lot Release Testing 8. Conclusion 9. References Annex 1. GHTF Classification Rules (refer to GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification )

20 Common Registration File: Adopt WHO s Dossier for Pre-qualification Table of Contents: Introduction Product dossier elements The product dossier checklist The product Design and manufacturing information Product performance specifications and associated validation and verification studies Labelling Commercial history Regulatory history Quality Management System

21 Conclusion PAHWP is evolving and need to tap into global efforts underway e.g. AHWP, ALADDIV, GHTF-IMDRF, WHO-PQ Realities of capacity limitations: lack of human technical capital and weak or absence of regulatory and legal frameworks for medical devices and diagnostics need to be addressed

22 Challenges Post Market Surveillance Sub-standard and IVD of unknown quality are sold in Africa Lack of Post Market Surveillance or batch testing of products Lack of platform for sharing information Lack of corrective and recall mechanisms Response Establish an African communication portal and work towards a common information management system Pilot project on feasibility of active surveillance devices and start with common tests e.g. rapid tests for HIV

23 Conclusion.. Several lessons have been learnt in Africa in the harmonization effort: process is slow, requires consultation; harmonization models exist; regulation based on science is key for harmonization; importance of effective legal and regulatory framework cannot be overemphasized; regulation to take into account issues of globalisation, cross-border trade, cross-border manufacturing should be considered in the harmonization agenda

24 Acknowledgements The SAMED meeting organisers LSHTM - Professor Rosanna Peeling and Dr Ruth Mc Merneny African Society for Laboratory Medicine Mr Paul Tanui AU-NEPAD Members of the PAHWP esp EAC PAHWP Executive & Technical Working Groups Chair: EAC rotates - Tanzania Vice Chair: Nigeria Secretariat: South Africa 24

25 The End Thank you Ke a Leboga Ndo Livhuwa Ndza Khensa Asante Sana Ngiyabonga E Nkosi Dankie Merci beaucoup Grazie Obrigado 25