East African Community Medicines Registration Harmonization Project Prepared by: Margareth Ndomondo-Sigonda African Union NEPAD Agency 13th February 2013 4/19/2017

Presentation Outline Brief background of the AMRH initiative Progress on EAC Medicines Registration Harmonization Project Continental progress Conclusion 4/19/2017

Background 4/19/2017

Member Countries of the African Union (AU) 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 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, Email: andriettef@nepad.org Information source: www.africa-union.org

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) 4/19/2017

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

2. AMRH Vision, Mission & Strategic Directions 4/19/2017

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 4/19/2017

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 4/19/2017

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

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

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

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

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

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

East African Community (EAC) Project on Medicines Registration Harmonization 4/19/2017

LOCATION MAP OF EAST AFRICA

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 4/19/2017

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 4/19/2017

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 4/19/2017

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 4/19/2017

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 4/19/2017

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

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 4/19/2017

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 4/19/2017

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 4/19/2017

Thank you for your attention! Merci!