East African Community
Medicines Registration Harmonization Project
Prepared by:
Margareth Ndomondo-Sigonda
African Union NEPAD Agency
13th February 2013
4/13/2015
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Presentation Outline
1. Brief background of the AMRH initiative
2. Progress on EAC Medicines Registration
Harmonization Project
3. Continental progress
4. Conclusion
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1. Background
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Created by: Mrs. Andriëtte Ferreira – NEPAD Secretariat, 1258 Lever Road, Headway Hill,
Midrand, Johannesburg, South Africa, Email: andriettef@nepad.org
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Ethiopia
Algeria
Angola
Libya
Benin
Madagascar
Botswana
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
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 (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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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
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
 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
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2. AMRH Vision, Mission & Strategic
Directions
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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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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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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
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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
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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)
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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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Critical Milestones
2. Regulatory capacity building & systems strengthening
Ad-hoc training programmes
Working Member States
independ Collaborate on
ently
training
programmes
Existing
training
program
mes for
NMRA
staff
based on
donor
funding
• Evaluation &
registration of
medicines
• GMP
Inspections
• Quality
Management
Systems
• Management
Information
Systems
•
Institutionalised training programmes
Harmonised training
standards and broad
collaboration
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
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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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East African Community (EAC) Project on
Medicines Registration Harmonization
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LOCATION MAP OF EAST AFRICA
N
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
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 2005-2009
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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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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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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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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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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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
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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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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
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– Stakeholders consultations planned for 2013
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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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Thank you for your attention!
M
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c
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