Pan-African Harmonization Working Party (PAHWP) on Medical Devices and Diagnostics Infrastructure and progress to date 3 rd African Regulatory Forum on.

Slide 1 Pan-African Harmonization Working Party (PAHWP) on Medical Devices and Diagnostics Infrastructure and progress to date 3 rd African Regulatory Forum on Medical Diagnostics Cape Town, November 30 th, 2014 Paul Tanui AU-NEPAD Agency Slide 2 NEPAD Agency Background New Partnership for Africa’s Development (NEPAD) Agency is a technical body of the African Union (AU) NEPAD primary objectives To eradicate poverty To place African countries, both individually and collectively, on a path of sustainable growth and development To halt the marginalisation of Africa in the globalisation process To accelerate the empowerment of women To fully integrate Africa into the global economy NEPAD on-going projects in different sectors of the economy including in Health and in particular the African Medicines Regulatory Harmonization (AMRH) Programme 2 Slide 3 About PAHWP 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 through a series of consultative meetings with relevant stakeholders that began in Nairobi in July 2012; experiences and lessons learnt from other regions in the world was shared 3 Slide 4 PAHWP History The PAHWP was conceived in 2012 following stakeholder meetings in East Africa, with an interim secretariat within the East African Community A base line survey of regulation of medical devices and medical diagnostics in EAC Partner States was undertaken in October 2012 The formation of PAHWP was announced in a satellite symposium at the African Society for Laboratory Medicine Conference on 3rd December 2012 in Cape Town The EAC Regional Task Force on Regulation of Medical Devices and Diagnostics meeting held in April 2013 in Dar-es-Salaam approved the proposed structure which was presented at the 1st African Regulatory Forum on Medical Diagnostics in July 2013. Slide 5 Expanding the reach of PAHWP Founding members: East African Community Health Secretariat (EAC) and the EAC partner States (Burundi, Rwanda, Kenya, Uganda, United Republic of Tanzania), Ethiopia, Nigeria and South Africa and the London School of Hygiene & Tropical Medicine. Partners include German International Co-operation (EAC-GIZ), the African Society for Laboratory Medicine (ASLM) and the World Health Organisation (WHO-AFRO, WHO-HQ). PAHWP has been anchored within the AU-NEPAD Agency regulatory harmonization programmeEACEAC-GIZASLMAFROWHO Efforts underway to engage RECs e.g. SADC, ECOWAS/WAHO, interested member states and industry associations Slide 6 Rationale for harmonization Why harmonization? Duplication in facility inspections and clinical trials 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 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 Slide 7 7 PAHWP vision of a streamlined future Earlier approval of medical devices and diagnostics Today  ~ 54 regulatory regimes governing medical device regulation across Africa, at different levels of development and efficiency  Regulators capacity highly variable, some with almost no capacity at all  Different requirements and formats, lack of clear guidelines  Minimal transparency, No clear timelines  Global regulatory efforts underleveraged Streamlined (harmonized) future  Between 5-7 regional economic communities (RECs) covering the entire African continent  Stronger, institutionalized regulatory capacity building programmes  Clear guidelines, harmonized requirements, procedures and standards  Transparent regulatory processes with clear timelines  Resource pooling and information sharing 7 Slide 8 PAHWP Vision, Mission & Goal The vision of PAHWP is that valuable, quality assured, safe medical devices and diagnostics are made available where needed The mission of the PAHWP is to protect public health Goal of PAHWP is to study and recommend ways to harmonize medical devices and diagnostics regulation in Africa Slide 9 Structure for Pan African Harmonization Working Party (PAHWP) for Medical Devices & Diagnostics African Regulatory Harmonization Advisory Committee for medicines, medical devices & diagnostics Pan African Harmonization working party for medical devices & diagnostics TWG Registration & Common Submission Dossier TWG Quality Audit & Inspection TWG Clinical Performance Studies TWG Post-Market Surveillance African Medicines Regulatory Harmonization(AMRH) TWG Medicines Policy & Regulatory Reforms Subgroups… African Medicines Regulatory Harmonization(AMRH) TWG on Regulatory Capacity Development Subgroups... EAC Project Steering Committee EAC Process: Sectoral Committee, Council of Ministers, Summit Slide 10 Current/outgoing PAHWP Leadership CHAIR: Kenya; current Chair of East African Community EAC VICE CHAIR: Nigeria; National Agency for Food and Drug Administration Control NAFDAC SECRETARY: South Africa; National Health Laboratory Service NHLS Slide 11 Advisory Committee meetings on held within the AU- NEPAD Agency coordinated Regulatory Harmonization Programme Advisory Committee Meetings held annually since March 2012(1 st meeting-Arusha, Tanzania) June 2013 (Nairobi, Kenya): PAHWP accepted as a member of the Advisory Committee; consequently the scope of the Advisory Committee expanded to include medicines, medical devices and medical diagnostics including IVDs March 2014 (Durban, South Africa): PAHWP updated the Advisory Committee on Progress made; PAHWP Report was adopted Slide 12 Key Meetings held With funding from a grant from Grand Challenges Canada to the LSHTM the following meeting were held: 1st African Regulatory Forum on Medical Diagnostics held July 2013 (Nairobi) Joint workshop with Asian Harmonization Working Party sub group on in vitro diagnostics held September 2013 (Taiwan) 2nd African Regulatory Forum on Medical Diagnostics held January 2014 (Cape Town) Workshop: policy framework and strategic plan for local production of in vitro diagnostics in developing countries – October 2014 3 rd African Regulatory Forum on Medical Diagnostics -November 2014 (Cape Town) Other training workshops; online learning materials; exercises Slide 13 1 st Regulatory Forum Shared the vision of PAHWP with major stakeholders and industry Briefed stakeholders on PAHWP work plan and timelines Discussed promotion and facilitation of linkages with AU- NEPAD, WHO and other regional harmonization working groups; inter-regional cooperation among African regional economic communities and regional health care organizations Developed a communication plan among stakeholders Slide 14 2 nd Regulatory Forum Reviewed the vision of PAHWP Reviewed progress and achievements of PAHWP technical working groups Identified gaps and challenges Discussed the way forward for PAHWP Discussed expansion of the PAHWP Slide 15 Priority areas for harmonization 1. Common Registration File Goal: A Common Registration File for IVD Medical Devices using point-of-care tests for CD4, viral load and early infant diagnosis as examples 2. Quality Systems Audit Goal: To reduce duplication, costs and delays associated with regulatory audits of manufacturers' quality management systems 3. Clinical Evidence Goal: Reduced duplication of studies for regulatory approval in African countries 4. Post Market Surveillance Goal: Safe, reliable diagnostic products across Africa 5. Risk Classification Goal: Standardised rules for classifying IVD for their regulation based on risk to individual and public health Slide 16 Recommendations of the 1 st African Regulatory Forum 1. Fifth harmonization priority: single risk classification for Africa? Recommendation: Add a Technical Working Group to take this forward. 2.In-country consultations Recommendation: Wait until the initial pilots are done and then formulate advocacy and communication tools for communication to countries. PAHPWP Founding members to form a taskforce to oversee the pilots and to develop the communication materials. 3. Promotion of best practice, including transparency Recommendation: Within the next 6 months the PAHWP should collect best practices that are relevant and already exist and identify gaps to fill through further efforts. The best practices will be put into case studies to be distributed via the PAHWP website and other mechanisms. 4. Capacity building plans Recommendation: Identify opportunities for capacity building and develop a comprehensive plan. Identify mechanisms and opportunities for implementation of the plan. 5. Industry engagement Recommendation: Establish opportunities for interactive engagement between regulatory bodies and industry including face-to-face meetings (ASLM conference satellite, Moving Forward in Diagnostics forum) and PAHWP forums and website. Slide 17 Recommendations of the 2 nd African Regulatory Forum PAHWP welcomed the invitation from ISO TC 212 to become a liaison member and agreed unanimously to accept this invitation. It was noted that PAHWP will apply in writing and following acceptance representation should be through the working groups. Countries may also participate through their national standards agencies. PAHWP agreed to form a Regulatory Framework Working Group that can study and review the GHTF risk based classification rules and related documents on a common dossier and the IMDRF Single Audit Program. Slide 18 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”) Slide 19 Risk-based Approach to Regulation of IVDs An essential feature of a model authority includes “the construction of a regulatory system that is risk-based, i.e. a system that stratifies and applies premarket assessment controls based on the risk (or hazard) potential of a product, as well as the potential for misuse and the breadth of commercial distribution, known or projected.” Slide 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 Slide 21 Joint Review of Clinical Performance Studies Training Workshops on Joint Review of Data from Clinical Performance Studies – Basic workshop, Arusha, Tanzania, July 2014 – Advanced workshop, Dar es Salaam, Tanzania, October 2014 Workshops will be held every 2-3 months in 2015 E-learning materials available on PAHWP website Slide 22 Inter-Regional Harmonization Priorities for IVDs Slide 23 Post market surveillance Response We shall establish an African communication portal and work towards a common information management system Pilot project on feasibility of active surveillance for rapid tests for HIV Challenges Lack of post market surveillance or batch testing of products Lack of platform for sharing information Lack of corrective and recall mechanisms Sub-standard and IVD of unknown quality are sold in Africa Slide 24 Pilot on rapid tests for HIV PAHWP PMS working group includes regulators, laboratory experts, medical stores, industry, MoH, academia and ASLM with representation from Ethiopia, Ghana, Kenya, Nigeria, South Africa, Tanzania and Uganda Work closely with WHO Build on work already done by Tanzania and WHO Post market surveillance Slide 25 http://www.biomedcentral.com/1472-6963/14/524 East African baseline study published in BMC Health Services Research Slide 26 Training materials http://www.pahwp.org/5.html Slide 27 ADVANCED TRAINING WORKSHOP 20-23rd OCTOBER 2014 DAR ES SALAAM 2015: rolling program of training in good review practice for clinical performance data Funded by UNITAID Slide 28 Asia Harmonization Working Party (AHWP) A non-profit organization of experts from medical device regulatory authorities and the medical device industry (23 member economies). Goals are to study and recommend ways to harmonize medical device regulations in the region in coordination with the GHTF, APEC and other related international organizations: South Africa & Tanzania The Latin American IVD Association (ALADDIV) Created in 2012 as a forum for regulators and other stakeholders to promote the convergence of regulatory standards and procedures in the region, consistent with efforts in other regions. Global Harmonization Task Force (GHTF) A voluntary group of representatives from national medical device regulatory authorities and industry ( Australia, Canada, EU, Japan, USA ). GHTF published and disseminated harmonized documents on basic regulatory practices and served as an information exchange forum. GHTF transformed to the International Medical Devices Regulatory Forum (IMDRF) a purely regulatory body which will continue to promote the principles of harmonization. Collaborations with other Harmonization efforts Slide 29 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 Slide 30 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 Slide 31 MERCI OBRIGADO THANK YOU شكرا