1. East African Community Medicines Registration Harmonization Project
Prepared by:
Margareth Ndomondo-Sigonda
African Union NEPAD Agency
13th February 2013
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2. Presentation Outline Brief background of the AMRH initiative
Progress on EAC Medicines Registration Harmonization Project
Continental progress
Conclusion
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3. Background
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4. Member Countries of the
African Union (AU)
Est.: OAU – May AU – July 2002
Tel: Fax: Website:
Head Office Address: P.O. Box 3243, Roosevelt Street (Old Airport Area), W21K19, Addis Ababa, Ethiopia
Algeria
Angola
Benin
Botswana
Burkina Faso
Burundi
Cameroon
Cape Verde
C/African Rep.
Chad
Comoros
DRC
Congo
Côte d’Ivoire
Djibouti
Egypt
Equatorial Guinea
Eritrea
Ethiopia
Gabon
Gambia
Ghana
Guinea
Guinea-Bissau
Kenya
Lesotho
Liberia
Libya
Madagascar
Malawi
Mali
Mauritania
Mauritius
Mozambique
Namibia
Niger
Nigeria
Rwanda
Sharawi Arab DR
São Tomé & Prínc.
Senegal
Seychelles
Sierra Leone
Somalia
South Africa
Sudan
Swaziland
Tanzania
Togo
Tunisia
Uganda
Zambia
Zimbabwe
Created by: Mrs. Andriëtte Ferreira – NEPAD Secretariat, 1258 Lever Road, Headway Hill, Midrand, Johannesburg, South Africa,
Information source:

5. 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: 895,800,000
8 Regional Economic Communities:
Arab Maghreb Union (UMA), Common Market for Eastern and Southern Africa (COMESA), Community of Sahel Saharan States (CEN-SAD), 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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6. 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

7. PMPA-AMRH Genesis
African Union Assembly Decision 55 of 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
AMRH critical 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

8. 2. AMRH Vision, Mission & Strategic Directions
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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
Knowledge Management
Knowledge assets on medicines regulation at country, regional and continental levels created
Community of Practice
1st Biennial Scientific Conference
Enabling environment for AMRH
Partnership Platform Accountability Framework
M&E and impact assessment tool implemented
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11. Presentation made on 19th July, 2012 at MSH Office, Arlington, USA
Consortium of key partners established to accelerate and ensure African Medicines Regulatory Harmonization (AMRH)
Consortium Partners
Other Stakeholders
NMRA Representatives
Consortium and major
stakeholders convened in
February and November
2009
COHRED
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

12. Presentation made on 19th July, 2012 at MSH Office, Arlington, USA
AMRH…
Approach:
Building on the existing regional efforts, political mandates and plan
Registration as pathfinder to a broader harmonization of other regulatory functions and products
Overall aim:
Improve public health by increasing access to safe and effective medicines of good quality for the treatment of priority diseases

13. Streamlined (harmonized) future of more medicines & vaccines
AMRH …
~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation across Africa
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
Today
Between 5-7 regional economic communities (RECs) covering the entire African continent1
Harmonized medicines policies and Laws
Stronger, institutionalized regulatory capacity & systems strengthening programmes
Single set of requirements, Clear guidelines, Fewer dossiers to prepare
Transparent regulatory processes with clear timelines
Resource pooling and information sharing
Streamlined (harmonized) future
Earlier approval
of more medicines & vaccines
1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP) 13

14. Presentation made on 19th July, 2012 at MSH Office, Arlington, USA
Critical Milestones
Harmonised requirements and standards
Not Harmonised
Fully 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
Joint evaluations and inspections
Sharing assessment and inspection reports
Quality Management Systems
Information Management Systems
Centralized registration on behalf of participating member states
Regional Medicines Agencies e.g. EAC-MFSA
National sovereignty is respected:
Medicines registration decisions remaining firmly that of sovereign nations
Robust & transparent regulatory processes

15. Presentation made on 19th July, 2012 at MSH Office, Arlington, USA
Critical Milestones
2. Regulatory capacity building & systems strengthening
Ad-hoc training programmes
Institutionalised training programmes
Working independently
Member States Collaborate on training programmes
Harmonised training standards and broad collaboration
Utilise Existing Regional structures & expertise: NMRAs & Academic institutions
Existing training programmes for NMRA staff based on donor funding
Evaluation & registration of medicines
GMP Inspections
Quality Management Systems
Management Information Systems
Harmonised training curriculum
Certification
Evaluation of training programmes
Potential partners: WHO, US-FDA, PQM, AfDB, EDCTP, ANDi, PDPs, SIAPS
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
Increased regulatory workforce in Africa

16. Presentation made on 19th July, 2012 at MSH Office, Arlington, USA
Critical Milestones
3. Policy and Regulatory Reforms
Inadequate policies & laws
Harmonised policies & Laws
Current status
Country level
Regional level
Continental level
Lack/Weak medicines laws
Medicines regulated within territories
Varying comprehensiveness of laws
No sanctions on non compliance to regional treaties
Adoption and domestication of model law on medicines regulation
Mutual recognition agreements
Binding regional legal instruments
At least 5 regions have adopted regionally harmonized policies and legislative frameworks
At least 20 countries implementing the regionally harmonized policies and legislative frameworks
At least 2 regional medicines agencies established
Increased adoption of regionally agreed standards
Mutual recognition of regulatory decisions
Establishment of regional medicines agencies

17. East African Community (EAC) Project on Medicines Registration Harmonization
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18. LOCATION MAP OF EAST AFRICA

19. EAC…
A regional grouping of 5 countries: Burundi, Kenya, Rwanda, Tanzania, Uganda
Population:133.1 million
GDP: USD 79.2 billion
GDP per capita ($685) as of 2011
Public health challenges:
Preventable communicable diseases responsible for the highest morbidity and mortality
Limited access to essential medicines for the treatment of preventable diseases
High prices, different drug registration requirements, Reliance on importation
Varied capacity of the six (6) EAC NMRAs
Chapter 21 (Article 118) of the EAC treaty concerning health issues in the Partner States priorities on health
Provides for regional cooperation among EAC Partner states on health, trade e,t,c
Harmonization of national health policies and regulations and promote the exchange of information on health issues
Harmonization of drug policies, registration and regulation

20. EAC Key Decisions… 2
Directive of the EAC Council of Ministers of 2000:
Research, Policy and Health Systems Working group to draft common Drug Policy and Harmonized drug regulation procedures
Meeting of Technical staff from NMRAs in EAC, Dar es Salaam 2001
Guidelines and application forms for registration of Veterinary Drugs
EAC Customs Union, January 2005
Common External Tariffs on raw materials and products
African Drug Regulators Conference, Addis Ababa 2005 recommendations
Promote harmonization using existing RECs, e.g, EAC, SADC, ECOWAS/WAHO, ECSA, etc
Various NMRA meetings held between

21. EAC MRH Process
May 2009: Submission of MRH project proposal to AMRH Consortium
May - September 2009
Approval of preparation of the EAC-MRH expended project by the 18th EAC Council of Ministers
Expanded EAC DRH Project Proposal EAC/NEPAD/WHO Meeting
May 2010 Zanzibar & Arusha, Tanzania
regional workshop to provide feedback & comments from AMRHI Consortium of Partners into the Expanded EAC MRH Project Proposal organised by EAC-WHO-NEPAD
EAC Secretariat and EAC NMRAs and the pharmaceutical industry, AU/NEPAD Agency and WHO incorporated comments and repackaged EAC MRH proposal
Sept - Nov 2010; Arusha, Tanzania and Nairobi, Kenya
EAC NMRAs, EAC Secretariat, AU/NEPAD, WHO, the World Bank , GIZ
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22. EAC MRH Process…
World Bank establishment of the Global Medicines Regulatory Harmonization Multi-Donor Trust Fund
Bill and Melinda Gates commitment US$ 12.5mill as start-up fund
May 2011: Fiduciary & Procurement Assessment of EAC conducted by World Bank
10th - 22nd October 2011: Project Appraisal Missions in EAC Partner States conducted
27th January 2012: Joint EAC/World Bank Negotiations of the Financial Grant Agreement conducted on Friday
30th March 2012
EAC MRH Project Launch, Arusha, Tanzania
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23. EAC-MRH Project Governance
Project Steering Committee supported by technical Working Groups
Provide oversight on MRH Project implementation
Composed of EAC Heads of NMRAs, Chief Pharmacists from Ministries of Health, members of four project Technical Working Groups & AMRH Partners (as observers)
2 meetings held in June 2012 & November 2012 in Bujumbura, Burundi and Arusha, Tanzania, respectively
Objectives:
receive progress reports from the EAC Partners States NMRAs and EAC Secretariat on the implementation of MRH Project activities;
Receive progress on the four Technical Working Groups (TWGs);
Review and approve annual work plans and budgets
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24. Technical Working Group on Medicines Evaluations & Registration
Tanzania Food and Drugs Authority (TFDA) – Lead; supported by Burundi Department of Pharmaceuticals and Medical Laboratories (DPML)
Key Milestones:
Draft EAC guidelines on format and content of labels for medicinal products
Draft EAC guidelines on the format and content of patient information leaflet (PIL) for Medicinal Products
Draft EAC guidelines on the format and content of summary of product characteristics for medicinal products (SmPC)
Draft EAC Guidelines on Stability requirements
Final draft of the EAC Application Form for registration of human medicines
Stakeholders consultation on draft guidelines planned for March 2013
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25. The Technical Working Group on Good Manufacturing Practises (GMP)
Uganda National Drug Authority (NDA) – Lead; supported by Rwanda Pharmacy Task Force (PTF)
Key Milestones:
Preparation of Terms of Reference for the TWG
Finalization of EAC GMP Inspection Manual,
EAC Standard Operating procedures (SOP) for conducting GMP inspection,
EAC GMP Report Writing Format,
EAC GMP Format for Executive Summary
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26. Technical Working Group on Information Management Systems (IMS)
Rwanda Pharmacy Taskforce (PTF) – Lead; supported by Pharmacy and Poisons Board (PBB), Kenya
Key Milestones:
Completion of Terms of Reference for the consultancy to conduct an assessment of the current state of the existing IMS aimed to:
design and develop technical specifications for a harmonized IMS in the EAC Partner States, NMRAs and the EAC Secretariat
Revised ToRs for the TWG
Completed draft guidelines for the development of the common IMS
4/19/2017

27. Technical Working Group on Quality Management Systems (QMS)
Pharmacy and Poisons Board (PBB) of Kenya – Lead; supported by Zanzibar Food and Drugs Board (ZFDB)
Key Milestones:
Finalised ToRs for QMS TWG
Completed draft documents on:
EAC Quality Management Requirements
Guidelines for implementation of EAC QMS requirements
EAC QMS Manual
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28. Continental Progress AMRH Advisory Committee established
NEPAD Agency Secretariat
Coordination and Political advocacy
Technical Working Groups
Regulatory Capacity Development
Medicines Policies & Regulatory Reforms
July 2012: 19th AU Assembly decision on Roadmap for Shared Responsibility and Global solidarity for the AIDS, TB and malaria response in Africa
emphasises on the need to accelerate and strengthen regional medicines regulatory harmonization initiatives
lay foundations for a single African regulatory agency
Draft Model law for Medicines Regulation Harmonization in Africa developed
Stakeholders consultations planned for 2013
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29. Conclusion
AMRH is a strategic initiative for pharmaceutical sector development in Africa
Strong political constituency and partnerships built
NMRAs, pharmaceutical industry & Civil Society, RECs and AU organs (AUC, NEPAD Agency, PAP)
Strong partnerships built with donors & international institutions
WHO, World Bank, UNAIDS, AFDB, DFID, Bill and Melinda Gates Foundation
Cooperation, collaboration and commitment by all stakeholders is key for success
EAC MRH Project provides a Model for replication to other RECs
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30. Thank you for your attention!
Merci!