1. the African Medicines Regulatory Harmonization and
Overview of
the African Medicines Regulatory Harmonization and
African Medicines Agency
Margareth Ndomondo-Sigonda
NEPAD Planning and Coordinating Agency
Midrand, Johannesburg
South Africa

2. OUTLINE Introduction to NEPAD
Background and Overview of the African Medicines Regulatory Harmonization (AMRH) Programme
African Medicines Agency
Operating Model
Vision, Mission & Objectives
Key actors, Milestones & Opportunities for Patients Engagement

3. NEPAD Agency Mandate
2001: The New Partnership for Africa's Development (NEPAD) is a socio-economic development programme of the African Union (AU) whose express objective is to stimulate Africa’s development by bridging the existing gaps with a view to address the socio-economic, political and environmental factors undermining public health.
2010: Transformed into a technical body of the African Union, the core mandate of the NEPAD Agency is:
To facilitate and coordinate the implementation of continental and regional priority programmes and projects;
To mobilise resources and partners in support of their implementation;
To conduct and coordinate research and knowledge management;
To monitor and evaluate the implementation of programmes; and
To advocate on the AU and NEPAD vision, mission and core values.

4. NEPAD Agency Mandate…
In its efforts to address Africa’s disease burden, NEPAD Agency contributed to the development of the 1st Africa Health Strategy ( ) and its subsequent review in 2016.
Provide technical assistance to the AU Member States, Regional Economic Communities (RECs), the African Union Commission (AUC) and Pan African Parliament (PAP) in facilitating implementation of priority health projects and programmes at national, regional and continental levels.
Consolidating efforts in the area of health and pharmaceuticals in line with AU and Global policy frameworks and strategies such as:
The Abuja Declaration on HIV/AIDS, Tuberculosis (TB), Malaria and other related infectious diseases (2001);
Africa Health Strategy ( );
Pharmaceutical Manufacturing Plan for Africa (PMPA) Business plan (2012);
Catalytic Framework to End AIDS, TB and Eliminate Malaria in Africa By 2030;
Agenda 2063; and Sustainable Development Goals (SDGs).

5. World Health Organization
13 November 2018
Background
15%
|World population in Africa
25%
|Global disease burden in Africa
Limited access to quality, safe and efficacious medicines is a key contributing factor to these health problems, partly due to lack of local pharmaceutical manufacturing capacity and weak medicines regulatory systems.
Africa has a high disease burden and high mortality from preventable and curable diseases,
partly due to inadequate health systems, scarce financial and human resources and unavailable and unaffordable medicines that are good quality, safe and efficacious.
inadequate capacity and resources on medical product regulation at national levels
No single country including well-resourced countries can efficiently and effectively regulate its own market alone in this globalized market.
Decision for the establishment of the African medicines regulatory agency (AMA) made by Heads of State & Govt

6. 8 5 Background… 55| AU Member States 1.13 billion Agenda 2063
Regional economic groups recognised by African Union
55| AU Member States 8
1.13 billion
Number of people on the African Continent 5
AU geographic regions
Agenda 2063
Aspiration 1: A Prosperous Africa, based on Inclusive Growth and Sustainable Development
Goal 1: A high standard of living, quality of life and wellbeing for all citizens
Goal 3: Healthy and well-nourished citizens
“achieve access to safe, effective, quality and affordable essential medicines and vaccines for all”.

7. Background
2007: AU Ministers Decision on PMPA
2012: PMPA Business Plan &
AU-Roadmap on Shared Responsibility & Global Solidarity for ATM response in Africa
2015: AU Executive Council Decision on AMRH as foundation for African Medicines Agency (AMA)
Creating an Enabling Regulatory Environment---AMRH
Pharmaceutical sector development (Optimizing the African Market for new medical products and technologies)
Increased access to medical products and technologies
2005: AU Decision55 on Development of the Pharmaceutical Manufacturing Plan for Africa (PMPA) within the NEPAD Framework

8. Medicines Regulatory Capacity in Africa
4% with moderately developed national regulatory capacity compared to countries of the developed world;
33% countries have regulatory capacity to carry out most functions to varying degrees;
24% have basic regulatory capacity to carry out minimum functions
39% have limited regulatory capacity to implement all the regulatory functions
(WHO Report, 2004)

9. Wide circulation of sub-standard and counterfeit medicines in Africa with subsequent drug resistance and reported deaths
Copyright: Shiho Fukada/Panos

10. AMRH Overview The Pathway Regional regulatory platforms
Is a partnership initiative formalized in 2009 and launched in the East African Community countries in 2012 (Tanzania, Uganda, Kenya, Burundi, Rwanda)
Partnership includes African countries (regulatory authorities) and regional blocs, NEPAD, AUC, PAP, WHO, Gates Foundation, DFID, PEPFAR/USG, GAVI, World Bank
Aims to improve the fragmented regulatory system for product registration in Africa by changing from a country-focused approach to a collaborative regional and simplified one
Stepwise approach - start by harmonizing and streamlining technical requirements for product registration, leading to increased and timely product access
Creates a platform to build African regulatory capacity by region
IGAD / AMU / CEN-SAD
ECCAS
OCEAC
ECOWAS
UEMOA
EAC
SADC COMESA
Regional regulatory platforms
Harmonized standards (technical requirements / guidelines)
Joint and regional dossier assessments /GMP inspections
Work sharing / pooling of resources
Streamlined decision-making processes
Reduced registration cycle time...
...starting with generics
...extending to other product categories (NCEs, vaccines, diagnostics)
Extending to other regulatory functions over time (clinical trials, safety surveillance, etc.)
Extending to other African regional blocs
The Pathway 10
© Bill & Melinda Gates Foundation

11. EAC Pharmacovigilance Project,
> 85% of Sub-Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels
WAHO/UEMOA
EAC
ECCAS/OCEAC
REC progress
CEN-SAD/UMA/COMESA
REC
Status
Comments
EAC
CEMAC-OCEAC
WAHO/UEMOA
SADC
IGAD
Implementation
In progress
Project Preparatory Phase
Launched March 2012
Launch Nov. 2016
Launched Feb 2015
Launched July 2015
2016
IGAD
Completed or in-process RECs
Countries covered
Total members*
% pop
covered
EAC & OCEAC
EAC, OCEAC, ECOWAS
EAC, OCEAC, ECOWAS, SADC
12 (20%)
26 (46%)
41 (74%) 11 26 41
17%
45%
72%
While EAC has made progress in the development of harmonized guidelines for registration, GMP inspection, quality management system and information management system, West African (ECOWAS/UEMOA) and Southern African (SADC) regions are to launch their MRH Project Steering Committees before end of 2014
SADC
EAC Pharmacovigilance Project,
AVAREF alignment with AMRH on clinical trials ethics and regulatory oversight
11/13/2018 11

15. EAC African Union Vision 54 countries 5regions 1 continent
AMA Milestones:
January 2015 AU Executive Council Decision on AMRH as a foundation for AMA
AMA Task Team established since Nov 2014
Legal, institutional framework and business plan drafted
AUC, WHO & NEPAD Agency Joint Secretariat
2018: AMA Launch
IGAD / AMU / CEN-SAD
WAHO / UEMOA
West Africa Medicines Agency
African Medicines Agency
EAC
East African Community Medicines and Food Safety Commission
ECCAS/
OCEAC
SADC/
COMESA
The African Medicines Regulatory Harmonization (AMRH) Programme provides a foundation for establishment of regional medicines agencies such as the East African Community Medicines and Food Safety Commission (as an offshoot of the MRH project) and in the long run the African Medicines Agency (AMA)
54 countries
5regions
1 continent

16. 2. AMA’s Business Model & Conceptual Framework

17. AMA’S Competitive advantage
It is increasingly becoming evident that no single country (rich or poor) has enough resources & capability to efficiently & effectively regulate the whole supply chain system alone in this globalised world.
1st AMA Stakeholders Consultation Meeting, February 2017, Birchwood Hotel, Johannesburg, South Africa

18. Pan-African Medicines Agency
Who’s going to do what?
National vs.
Regional /Continental
Pan-African Medicines Agency

19. African Medicines Agency
(A) Specialized Agency of the African Union (AU),
(THAT) Serve as a catalyst for stronger regulatory oversight
(1) to curtail medical products that are SSFFCs,
(2) enable competitiveness of locally produced medicines
(BY) Galvanize (1) technical support, (2) expertise in various countries and RECs, and (3) resources at a scale that cannot be matched at national or regional level.
(TO) increase availability of affordable, quality, safe and efficacious medical products on the continent.
1st AMA Stakeholders Consultation Meeting, February 2017, Birchwood Hotel, Johannesburg, South Africa

20. AMA Vision, Mission & Objectives
ensure the coordination and strengthening of continental initiatives to harmonize medical products regulation;
To be the leader in creating an enabling regulatory environment for medical products in Africa.
provide guidance and technical support to, and complement and enhance the efforts of, the regional economic communities (RECs), regional health organizations (RHOs) and Member States,
Mission
To protect public health and promote pharmaceutical sector development in Africa by ensuring that medical products in use meet internationally recognized standards of quality, safety and efficacy.
contribute to improving access to quality, safe and efficacious medical products and health technologies on the continent.
1st AMA Stakeholders Consultation Meeting, February 2017, Birchwood Hotel, Johannesburg, South Africa

21. Key Functions of AMA
Promote the adoption and harmonization of medical products regulatory policies and standards, and scientific guidelines, and coordinate existing regulatory harmonization efforts in the RECs and RHOs;
Provide regulatory guidance, scientific opinions and a common framework for regulatory actions on medical products, as well as priority and emerging issues and pandemics;
Examine, discuss and/or express regulatory guidance on any regulatory matter within its mandate, either on its own initiative or at the request of the African Union, Regional Economic Communities, or Member States;
Provide technical assistance, where possible, on regulatory matters to countries that lack the capacity and resources to do so themselves;
Provide guidance on regulation of traditional medical products;
Provide guidance on regulation of clinical trials on medical products and health technologies;
Designate, promote, strengthen, coordinate and monitor RCOREs with a view to developing the capacity of medical products regulatory professionals;
Promote international cooperation and seek partnerships that will lead to effective mobilization of financial and technical resources to ensure sustainability of the AMA;
Promote and advocate for the use of the AU Model Law on medical products regulation in member states and RECs to facilitate regulatory and legal reforms at continental, regional and national levels;
Convene in collaboration with the WHO, the AMRC and other bodies, meetings related to medical products regulation in Africa;
Collect, manage and disseminate relevant information and knowledge;
Develop systems to monitor, evaluate and assess the comprehensiveness of national medical products regulatory systems with the view to recommending interventions that will improve efficiency and effectiveness;
Mobilize regulatory expertise across the continent and beyond to provide scientific opinions in consultation with affected Member State NMRAs, in the event of a public health emergency on the continent with cross border or regional implications where new medical products are to be deployed for investigation and clinical trials.

22. Conceptual Framework for Medicines Regulation
GOAL
(1) Time to approval; (2) incidence of SSFFCs, (3) # of certified suppliers per essential medicine, (4) compliance rate to GMP & GxP standards, (5) # of reported ADRs per 100,000 population
Human resources, Financial resources, Political support / will, infrastructure and equipment, legal framework
Quality Control
GxPs inspection (external)
Review of multi-country clinical trials
Review of dossiers
Registration of medicines (centralized process)*
Collaboration
Review & approval of clinical trials
Registration of medicines
Licensing & inspection (local)
Import & export control
Pharmacovigilance*
Medicine information*
National level
(a) # of submitted & approved products , (b) # of approved facilities, (c) # of submitted & approved clinical trials, (d) % of samples tested, (e) # of ADRs/product related reports
(a) # of products reviewed & approved, (b) # of facilities inspected & approved based on reliance (recognition of decisions by others), work-sharing, & centralised procedures, (c) # of reviewed multi-country trials, (d) utilisation of certified QC labs
Access to safe, effective, good quality and affordable essential medicines & health technologies
OUTCOMES
OUTPUTS
ACTIVITIES
INPUTS

23. Key Actors National Medicines Regulatory Authorities (NMRAs)
Regional Economic Communities (RECs)
Regional Health Organizations (RHOs)
National Ethics Committees (NECs)
African Union Commission (AUC);
Civil Society Organizations in Health nominated by an AU-recognised regional CSO forum
Opportunity for patients engagement

24. Next steps and corresponding timelines
Milestones
Next steps and corresponding timelines
Consideration of the status report on implementation of milestones towards establishment of AMA and Report of 2nd Member States’ Consultations on the Legal and Institutional Frameworks and Business plan of the AMA milestones by African Ministers of Health at special session of the STCHPDC
March 2017
3rd Member States’ experts consultations on the legal framework, institutional framework and business plan for AMA
Q3 2017
Working group of the Ministers of Health of STCHPDC to consider legal framework, institutional framework and business plan for AMA
 Q4 2017
Consideration of the legal framework and the Agreement for establishment of AMA by the STC on Legal and Justice Affairs
2018
Decision/Endorsement by the Assembly of Heads of State and Governments(Launch of AMA)
July 2018

25. Thank you!