1. 3rd African Regulatory Forum on Medical Diagnostics
Pan-African Harmonization Working Party (PAHWP) on Medical Devices and Diagnostics Infrastructure and progress to date
3rd African Regulatory Forum on Medical Diagnostics
Cape Town, November 30th, 2014
Paul Tanui
AU-NEPAD Agency

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

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

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.

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 programme
Efforts underway to engage RECs e.g. SADC, ECOWAS/WAHO, interested member states and industry associations

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

7. PAHWP vision of a streamlined future
~ 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
Today
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
Earlier approval
of medical devices and diagnostics 7

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

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 Process: Sectoral Committee, Council of Ministers, Summit
EAC Project Steering Committee

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

11. Advisory Committee meetings on held within the AU-NEPAD Agency coordinated Regulatory Harmonization Programme
Advisory Committee Meetings held annually since March 2012(1st 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

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
3rd African Regulatory Forum on Medical Diagnostics -November 2014 (Cape Town)
Other training workshops; online learning materials; exercises

13. 1st 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

14. 2nd 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

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   

16. Recommendations of the 1st African Regulatory Forum
Fifth harmonization priority: single risk classification for Africa?
Recommendation: Add a Technical Working Group to take this forward.
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.
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.
Capacity building plans
Recommendation: Identify opportunities for capacity building and develop a comprehensive plan. Identify mechanisms and opportunities for implementation of the plan.
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.

17. Recommendations of the 2nd 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.

18. Risk Classification of IVDs: WHO 2014
Table of Contents:
1. Introduction
2. Intended Audience and Scope
3. Definitions
4. Abbreviations
5. Risk Classification
Assessing IVDs – Critical Elements
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”)

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.”

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. 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

22. Inter-Regional Harmonization Priorities for IVDs

23. Post market surveillance
Sub-standard and IVD of unknown quality are sold in Africa
Challenges
Lack of post market surveillance or batch testing of products
Lack of platform for sharing information
Lack of corrective and recall mechanisms
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

24. Pilot on rapid tests for HIV
Post market surveillance
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

25. East African baseline study published in BMC Health Services Research

26. Training materials

27. 2015: rolling program of training in good review
practice for clinical performance data
Funded by UNITAID
ADVANCED TRAINING WORKSHOP 20-23rd OCTOBER DAR ES SALAAM

28. Collaborations with other Harmonization efforts
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.
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.

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

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

31. MERCI OBRIGADO THANK YOU شكرا