The document summarizes the African Medicines Regulatory Harmonisation (AMRH) Initiative. It discusses the background and vision of AMRH, which aims to improve access to essential medicines through regulatory harmonization across Africa. It outlines achievements including establishing an advisory committee and technical working groups, developing a model law, and launching regulatory harmonization projects in several regions. The document also notes industry support for AMRH and how regulatory harmonization can boost healthcare, access to new drugs, and the pharmaceutical industry in Africa over the short and long term. It concludes by highlighting next steps such as expanding the scope of harmonization and establishing sustainable training programs.

1. African Medicines Regulatory Harmonisation
(AMRH)
Initiative:
Presentation by Margareth Ndomondo-Sigonda
Pharmaceutical Coordinator
NEPAD Agency
26 March, 2013
1

2. Presentation Outline
1.
2.
3.
4.
Background
AMRH Vision, Mission, SD & Partners
AMRH achievements
Pharma Industry participation
•
•
•
Perceptions by local manufacturers
Opportunities for local manufacturers
Market Viability
5. Conclusion & Way Forward
2

3. 1. AMRH Initiative Background
3

4. New Partnership for Africa’s Development
(NEPAD)
• 2001: A Programme of the African Union (AU) adopted in
Lusaka, Zambia
• February 2010: Integration of NEPAD under the AU structures
• Re-newed mandate as a technical body of the African Union
to:
• Facilitate and coordinate the implementation of the
continental and regional programmes and projects;
• Mobilize resources and partners in support of the
implementation of Africa’s priority programmes and
projects;
• Conduct and coordinate research and knowledge
management;
• Coordinate the implementation of programmes and
projects, &
• Advocate on the AU and NEPAD vision, mission and core
principles/values

5. Est.: OAU – May 1963 AU – July 2002
Tel: +251-11 551 77 00 Fax: +251-11 551 78 44 Website: www.africa-union.org
Head Office Address: P.O. Box 3243, Roosevelt Street (Old Airport Area), W21K19, Addis Ababa,
Ethiopia
Algeria
Libya
Benin
Madagascar
Botswana
Created by: Mrs. Andriëtte Ferreira – NEPAD Secretariat, 1258 Lever Road, Headway
Hill, Midrand, Johannesburg, South Africa, Email: andriettef@nepad.org
Information source: www.africa-union.org
Angola
Malawi
Burkina Faso
Mali
Burundi
Mauritania
Cameroon
Mauritius
Cape Verde
Mozambique
C/African Rep.
Namibia
Chad
Niger
Comoros
Nigeria
DRC
Rwanda
Congo
Sharawi Arab DR
Côte d’Ivoire
São Tomé & Prínc.
Djibouti
Senegal
Egypt
Seychelles
Equatorial Guinea
Sierra Leone
Eritrea
Ethiopia
Gabon
Gambia
Ghana
Guinea
Guinea-Bissau
Kenya
Lesotho
Liberia
Somalia
South Africa
Sudan
Swaziland
Tanzania
Togo
Tunisia
Uganda
Zambia

6. African Union
• 54 member states of the African Union
– fifty two republics, and two kingdoms
– South Sudan is the newest member state, joining on 2011
July 27
• Total population: ~ 1 billion
• 8 Regional Economic Communities:
– Arab Maghreb Union (UMA), Common Market for Eastern and
Southern Africa (COMESA), Community of Sahel Saharan States (CENSAD), East African Community (EAC), Economic Community of Central
African States (ECCAS), Economic Community of West African States
(ECOWAS), Intergovernmental Authority on Development (IGAD) and
Southern Africa development Community (SADC)
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7. PMPA-AMRH Genesis
African Union Assembly Decision 55 of 2005 - Abuja Summit:
 African Union Commission (AUC) to develop a Pharmaceutical
Manufacturing Plan for Africa (PMPA) within the NEPAD Framework
 Aim: to contribute to a sustainable supply of quality essential medicines
to improve public health and promote industrial and economic
development on the continent
 Critical elements for successful implementation of PMPA :
 Legislative framework: Sound regulatory systems e.g. GMP, GDP, GCP
e.t.c.
 Full use of TRIPS and related flexibilities
 Appraisal of technical feasibility and financial viability
 A market size to ensure sustainability
 Technology transfer
 Human resource
 Duties and taxes
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8. 2. AMRH Vision, Mission, Strategic
Directions & Partners
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9. AMRH VISION & MISSION
VISION:
African people have access to essential medical
products and technologies
MISSION:
Provide leadership in creating an enabling
regulatory environment for pharmaceutical
sector development in Africa
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10. AMRH Strategic Directions
• Policy and Regulatory Reforms
– Increased use of harmonized policies and regulatory frameworks
by member states
• Regulatory capacity Development
– Increased human and institutional capacity for regulation of
medical products and technologies
– Use of existing structures & institutions to ensure sustainability
• Knowledge Management
– Knowledge assets on medicines regulation at country, regional
and continental levels created
• Enabling environment for AMRH
– Governance & coordination
– Partnership Platform Accountability Framework
– M&E and impact assessment framework
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11. Consortium of key partners established to accelerate and
ensure African Medicines Regulatory Harmonization
(AMRH)
Consortium Partners
NMRA Representatives
Other Stakeholders
COHRED
Consortium and major
stakeholders convened in
February and November
2009
Regional Economic Communities and Organizations (RECs)
•
•
Unanimous consensus emerged: now is the right time to push for regulatory
harmonization in Africa
Global Medicines Regulatory Harmonization - Multi-Donor Trust Fund established
under the World Bank
11

12. AMRH Partners….
 Political/Technical/Operat
 AMRH Partners Roles
ional
•
•
•
•
•
New Partnership for Africa’s
Development (NEPAD Agency)
African Union Commission
(AUC)
Pan African Parliament (PAP)
World Health Organization
(WHO)
The World Bank
 Donors & NGOs
•
•
•
Bill & Melinda Gates
Foundation
UK Department for
International Development
(DFID)
Clinton Health Access Initiative
(CHAI)
• Mobilising political support, and
financial and technical resources for
AMRH programme
• Promoting and facilitating inter-REC
communication, coordination, technic
al consistency and shared learning
• Building a continental
initiative, assisting in priority setting
and plans for regulatory
harmonization
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13. AMRH…
• Overall Objective
– To improve public health by increasing access to quality,
safe and efficacious essential medicines for the
treatment of priority diseases
– Contribute to socio-economic development agenda for
Africa
• Specific Objective
– To reduce the time taken to register priority medicines
– Registration as pathfinder to a broader
harmonization of other regulatory functions and
products
13

14. AMRH Approach…
Building on the existing regional
efforts, political mandates and plan
14

15. AMRH …
 ~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation
across Africa
Today
 Lack/inadequate medicines policies and laws
 Regulators' capacity highly variable: Financial, HR, Institutional
 Different requirements and formats, lack of clear guidelines
 Minimal transparency, No clear timelines
 Reference evaluations1 underleveraged
 Between 5-7 regional economic communities (RECs)
covering the entire African continent1
Streamlined
(harmonized)
future
 Harmonized medicines policies and Laws
 Stronger, institutionalized regulatory capacity & systems
strengthening programmes
Earlier
approval
of more
medicines &
vaccines
 Single set of requirements, Clear guidelines, Fewer
dossiers to prepare
 Transparent regulatory processes with clear timelines
 Resource pooling and information sharing
1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP)
15
15

16. Critical Milestones
1. Harmonised requirements and standards
Fully Harmonised
Not Harmonised
Member States
Operating
independently
Member States
Collaborate on selected
topics
Harmonised
standards and
broad collaboration
Centralized
Procedure
• each country has
its own technical
requirements
and format for
registration
applications
Regional harmonised
guidelines & procedures:
• Guidelines for
registration of
medicines
• Procedures for
evaluation of
medicines
• GMP guidelines &
Inspection procedures
•
Centralized
registration on
behalf of
participating
member states
•
•
•
Joint evaluations
and inspections
Sharing
assessment and
inspection reports
Quality
Management
Systems
Information
Management
Systems
Regional
Medicines
Agencies e.g. EACMFSA
National sovereignty is respected:
Medicines registration decisions remaining firmly that of sovereign nations
Robust & transparent regulatory processes
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17. Critical Milestones
2. Regulatory capacity development
Ad-hoc training programmes
Working Member States
independ Collaborate on
ently
training
programmes
Existing
training
program
mes for
NMRA
staff
based on
donor
funding
Institutionalised training programmes
Harmonised training
standards and broad
collaboration
• Evaluation &
registration of
medicines
• GMP
Inspections
• Quality
Management
Systems
• Management
Information
Systems
•
Utilise Existing Regional structures
& expertise: NMRAs & Academic
institutions
• Harmonised
training curriculum
• Certification
• Evaluation of
training
programmes
• Potential partners:
Short Term:
• Twinning/Exchange
programmes among NMRAs
within & outside the continent
• Regional Centres of Regulatory
Excellence (RCORE)
Long-Term:
• Engagement of academic
institutions to offer post
graduate courses in Regulatory
Science
WHO, US-FDA,
PQM, AfDB,
EDCTP, ANDi,
PDPs, SIAPS
Increased regulatory workforce in Africa
17

18. Critical Milestones
3. Policy and Regulatory Reforms
Inadequate policies & laws
Harmonised policies & Laws
Current status
Country level
• Lack/Weak
medicines laws
• Medicines
regulated within
territories
• Varying
comprehensivenes
s of laws
• No sanctions on
non compliance to
regional treaties
• Adoption
• Binding
• At least 5 regions have
and
regional
adopted regionally
domesticati
legal
harmonized policies and
on of model
instruments
legislative frameworks
law on
• At least 20 countries
medicines
implementing the regionally
regulation
harmonized policies and
legislative frameworks
• Mutual
• At least 2 regional medicines
recognition
agencies established
agreements
•
Regional level
Continental level
Increased adoption of regionally agreed standards
• Mutual recognition of regulatory decisions
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19. 3. AMRH Achievements
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20. 1. GMRH Multi-Donor Trust Fund
• The World Bank administration of a Global Medicines
Regulatory Harmonization Multi-Donor Trust Fund
(GMRH-MDTF)
• Initial funds to cover EAC Medicines Registration
Harmonization Project and AMRH Partners
• US$ 12.5 million
• Bill & Melinda Gates Foundation provided initial start-up
grant while other interested donors are engaged
• Strategically mobilize resources to cover other RECs
• Sustainable domestic financing options
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20

21. 2. CONTINENTAL PROGRESS
• AMRH Advisory Committee established
– NEPAD Agency Secretariat: Coordination and Political advocacy
– Provides strategic and policy advise on AMRH programme
implementation
– Composed of representatives from RECs, NMRAs, AUC, PAP,
NEPAD, WHO, World Bank, industry associations, civil society
• Technical Working Groups
– Regulatory Capacity Development
– Medicines Policies & Regulatory Reforms
• Draft Model Law for Medicines Regulation Harmonization
in Africa developed
– Stakeholders consultations planned for 2013
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22. CONTINENTAL PROGRESS…
Related Continental Frameworks
• July 2012: 19th AU Assembly decision on Roadmap for
Shared Responsibility and Global solidarity for the
AIDS, TB and Malaria response in Africa
– Emphasis - accelerate and strengthen regional
medicines regulatory harmonization initiatives
– Establishment of regional medicines agencies
– Foundation for a single African Regulatory Agency
– Lead Partners: AUC, UNAIDS & NEPAD Agency
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23. 3. REGIONAL PROGRESS
East African Community
•
Launch & subsequent implementation of EAC Medicines Registration
Harmonization (MRH) Project since March 2012
•
5 EAC Partner States (6 NMRAs) participating in the AMRH Initiative:
Burundi, Kenya, Rwanda, Tanzania, Uganda
•
MRH Project Steering Committee Established
•
Technical Working Groups (TWG) established to develop registration
and GMP guidelines and procedures in line with internationally
acceptable standards
•
Partner States NMRAs taking lead
•
•
•
•
Tanzania: TWG on medicines evaluation & registration
Uganda: TWG on good manufacturing inspection
Kenya: TWG on quality management systems
Rwanda: TWG on Information Management System (IMS)
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23

24. REGIONAL PROGRESS…
West African region:
• 15 participating member states
• 2011: Development of MRH Project framework in
consultation with industry
• August – Nov 2012:
– WAHO, UEMOA, WHO & NEPAD Agency High Level consultation
meetings
– Experts consultation meetings
– WAHO engagement of 7 countries (5 Anglophone & 2 Lusophone)
– UEMOA engagement of 8 Francophone countries
• 2013: WAHO/UEMOA Regional coordination framework, plan of action
and Memorandum of Understanding
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25. REGIONAL PROGRESS…
Central African region
• 10 participating member states
• 2009-11: Situation analysis and development
of a project framework for OCEAC/ECCAS
• 2012: Consultation with OCEAC and ECCAS
• 2013: Consultation on OCEAC/ECCAS
Regional coordination framework, plan of
action and memorandum of understanding
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26. 4. PHARMA INDUSTRY PARTICIPATION
• 2010-2012: NEPAD commissioned situation
analysis of medicines regulation & harmonization
across African RECs and countries
– National & regional policy & legislative frameworks
– NMRAs assessment
• 3 categories based on agreed criteria; i) Existing NMRA; ii) Existing
legal framework; iii) performance of full regulatory functions
(registration, GMP); iv) Existing Management Information System; v)
Available HR
– Industry perception on AMRH
• Consultation through National & regional industry associations
• General agreement
• EAC, SADC, ECOWAS consultation meetings
– Development of regional MRH Frameworks
26

27. AMRH Coverage Roughly 85% of Sub-Saharan
Africa
REC Status/Progress
Countries
covered
Population
(Mill)
Pharma
market
(US$ Bill
p.a.)
EAC
ECCAS/OCEAC
ECOWAS-WAHO/UEMOA
SADC
UMA/CENSADC/COMESA/IGAD
5
10
15
15
9
133.1
120
~300
267.58
N/A
N/A
N/A
3.5 (2010)
3 (2006)
N/A
Total:
54
•
We are pushing forward with RECs that are
willing
Industry participation in stakeholders
consultation is key
National & regional industry association a good
platform for engagement
RECs
•
•
Source: BCG analysis
EAC
ECCAS/
OCEAC
SADC
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27

28. AMRH contribution to Pharma Industry Development dev
Prevention and treatment of
infections diseases (overall)
Short term
Intermediate
term
Long term


Enhanced access to
new health technologies
Broad economic
development in the
region
Increased access to
generics treating many
important diseases
Broader, more rapid
access to vaccines and
other therapies


Extension to all regulatory
functions



More efficient
launches for vaccines and
other PDP products
Greater impact of new lifesaving technologies
Foundation for
African pharma industry
(PMPA)
• Benefit to Regional
Economic & Trade Treaties
• Increased market access
Healthier, more
productive workforce
28
28

29. 5. WAY FORWARD
• Regional Stakeholders consultation
– EAC harmonised guidelines & procedures
– AMRH Model Law
• Institutionalization of the regulatory training programmes in
the continent
– Establishment of Regional centres of regulatory Excellence
(RCOREs)
– Training for regulators & industry
– Key for sustainability
• Expanding the scope for harmonization to clinical trials
oversight and safety monitoring
• Governance and effective coordination regionally &
continentally
– Establishment of Partnership Platform Accountability Framework
– Impact assessment of policy & regulatory reforms in Africa
29

30. WAY FORWARD…
• 1st Scientific conference for medicines regulation in
Africa
– Theme:
“Building Partnerships for Sustainable Capacity Development in
Medicines Regulation in Africa”
– Target group: African regulatory authorities, researchers,
academic institutions and industry
• Necessity of working together to address socio-economic issues
affecting the African populace
– Call for Abstracts
• Read: AMRH-PMPA Policy Brief
• Visit: www.amrh.org
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31. CONCLUSION
• AMRH is a strategic initiative for pharmaceutical sector
development in Africa
• Strong political constituency and partnerships built
– AU organs (AUC, NEPAD Agency, PAP), RECs, NMRAs,
pharmaceutical industry & Civil Society
– Donors, development partners & international agencies
• Cooperation, collaboration and commitment by all
stakeholders is key for success
– Need practical alignments & engagement between African
NMRAs, industry, academia and researchers
• EAC MRH Project provides a Model for replication to other
RECs
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32. Thank You!
Merci!
Obrigado!
Ahsanteni Sana!
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