east african community medicines registration harmonization project prepared by: margareth...
TRANSCRIPT
East African Community
Medicines Registration Harmonization Project
Prepared by:Margareth Ndomondo-SigondaAfrican Union NEPAD Agency13th February 2013
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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
Est.: OAU – May 1963 AU – July 2002Tel: +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
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
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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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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 FrameworkAim: to contribute to a sustainable supply of quality essential medicines to improve public health and promote industrial and economic development on the continentAMRH 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 implemented04/19/23 10
Consortium of key partners established to accelerate and ensure African Medicines Regulatory Harmonization
(AMRH)
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Consortium and majorstakeholders convened inFebruary and November
2009
Consortium Partners
Other Stakeholders NMRA Representatives
Regional Economic Communities and Organizations (RECs)
COHRED
• 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
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 …
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Earlier approvalof more
medicines & vaccines
Today
~ 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
Streamlined (harmonized)
future
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 sharing1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP) 13
Critical Milestones
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
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1. Harmonised requirements and standards
Not Harmonised Fully Harmonised
National sovereignty is respected: Medicines registration decisions remaining firmly that of sovereign nations
Robust & transparent regulatory processes
Critical Milestones
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
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2. Regulatory capacity building & systems strengthening
Ad-hoc training programmes Institutionalised training programmes
• Increased regulatory workforce in Africa
Critical Milestones
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
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3. Policy and Regulatory Reforms
Inadequate policies & laws Harmonised policies & Laws
• Increased adoption of regionally agreed standards• Mutual recognition of regulatory decisions
• Establishment of regional medicines agencies
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East African Community (EAC) Project on Medicines Registration Harmonization
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 budgets04/19/23 23
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– Stakeholders consultations planned for 2013
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!
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