THE AFRICAN MEDICINES REGULATORY HARMONIZATION (AMRH) INITIATIVE Accomplishments, Challenges and Path Forward

THE AFRICAN MEDICINES REGULATORY HARMONIZATION (AMRH) INITIATIVE Accomplishments, Challenges and Path Forward

THE AFRICAN MEDICINES REGULATORY HARMONIZATION (AMRH) INITIATIVE Accomplishments, Challenges and Path Forward Cape Town Pre-ICDRA 27 November 2016

Objective To provide background and overview of the AMRH Initiative Accomplishments Challenges and Path Forward

2005: AU Decision55 on Development of the Pharmaceutical Manufacturing Plan for Africa (PMPA) within the NEPAD Framework Background Creating an Enabling Regulatory Environment---AMRH 2007: AU Ministers Decision on PMPA 2012: PMPA Business Plan & AU-Roadmap on Shared Responsibility & Global Solidarity for ATM response in Africa 2015: AU Executive Council Decision on AMRH as foundation for African Medicines Agency (AMA) Pharmaceutical sector development (Optimizing the African Market for new medical products and technologies) Increased access to medical products and technologies

AMRH OVERVIEW Is a partnership initiative formalized in 2009 and launched in the East African Community countries in 2012 (Tanzania, Uganda, Kenya, Burundi, Rwanda) Partnership includes African countries (regulatory authorities) and regional economic communities, WHO, PAP, AUC, NEPAD, Gates Foundation, DFID, PEPFAR/USG, GAVI, World Bank Aims to improve the fragmented regulatory system for product registration in Africa by changing from a country-focused approach to a collaborative regional and simplified approach Stepwise approach - start by harmonizing and streamlining technical requirements for product registration, leading to increased and timely product access Creates a platform to build African regulatory capacity by region ECOWAS UEMOA ECCAS OCEAC IGAD / AMU / CEN-SAD EAC SADC COMESA Initial focus Regional regulatory platforms Harmonized standards (technical requirements / guidelines) Joint and regional dossier assessments / GMP inspections Work sharing / pooling of resources Streamlined decision-making processes Reduced registration cycle time......starting with generics...extending to other product categories (NCEs, vaccines, diagnostics) Extending to other regulatory functions over time (clinical trials, safety surveillance, etc.) Extending to other African regional blocs 5

Accomplishments

Roughly 85% of Sub-Saharan Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels REC EAC CEMAC-OCEAC WAHO/UEMOA SADC North/North- Eastern Africa Completed or in-process RECs EAC & OCEAC EAC, OCEAC, ECOWAS EAC, OCEAC, ECOWAS, SADC REC progress Status Comments Implementation In progress Implementation Implementation Preparatory Stage Launched March 2012 Launch Nov. 2016 Launched Feb 2015 Launched July 2015 Countries covered 12 (20%) 26 (46%) 41 (74%) Total members* We are pushing forward those RECs that are ready while continuing to work with the remaining regions 11 26 41 % pop covered 17% 45% 72% ECCAS/OCEAC SADC CEN-SAD/UMA/COMESA IGAD EAC 11/29/2016 7 7

East African Community (EAC) The Model Region Progress attained EAC MRH Launch in March 2012 Harmonized standards (technical guidelines and requirements) approved by Council of Ministers Registration of medicines Good Manufacturing Practices (GMP) Quality Management System (QMS) Information Management System (IMS) Came into force from Jan. 2015, countries at different levels of implementation Twinning programme Burundi - Tanzania (Mainland) Rwanda Uganda Zanzibar Kenya (&TFDA) Systemically expanding to other regulatory functions and products Pharmacovigilance (PV) Medical devices & diagnostics, Clinical Trials Oversight Vaccine registration harmonization Lead country approach: Tanzania (TFDA) - product evaluation & registration Uganda NDA - GMP inspections Kenya PPB - QMS & PV Rwanda - IMS Joint assessments and inspections 27 applications assessed jointly, 4 products registered reduced registration time to <6months Streamlined GMP inspections 8

West Africa Region Progress attained ECOWAS and WAEMU launched a Medicines Regulatory Harmonization (MRH) Project in February 2015 Economic Community of West African States (ECOWAS) and the West African Economic and Monetary Union (WAEMU) Communique signed by 15 heads of ECOWAS National Regulatory Authorities on 3 rd July 2014 1 st Meeting of Joint MRH Project Steering Committee, February 2015 2 nd Steering Committee meeting, 20 April, 2016 Alignment of WAHO and WAEMU Common Technical Document (CTD) Development of the technical requirements based on the harmonized CTD Operationalization of the 7 Expert Working Groups (EWG) Recruitment of MRH Project Staff 9

Southern Africa Development Community (SADC) Region Progress attained March 2011: MRH Framework Agreed by SADC NMRAs October 2013 implementation of MRH Framework Breakthrough Activities under DfID (SARPAM) Funding of ZaZiBoNa scheme 2014 Official Integration of ZAZIBONA Scheme into SADC Framework for Regulatory Harmonization 21-24 July 2015, SADC Regulators Forum Official Endorsement of Implementation of MRH Programme DfiD-funded collaboration initiative between Zambia, Zimbabwe, Botswana and Namibia (ZaZiBoNa) for work-sharing in assessing registrations files submitted by pharmaceutical manufacturers. Between October 2013 and February 2016, the initiative has: Evaluated 116 products, resulting in 46 (40%) products being recommended for registration; and 26 (22%) products recommended for rejection; The mean time from assessment to recommendation was 8.84 months, representing both the regulator and applicants time. 10

Other Regions: Progress and Priorities Region Progress attained Central Africa: Regional pharmaceutical policy in 6 CEMAC Member States 1 st MRH Project Steering Committee convened 15-16 November 2016 The Economic and Monetary Community of Central Africa (CEMAC) Member States include; Cameroon, Congo (Brazzaville), Gabon, Equatorial Guinea, the Central African Republic (CAR) and Chad In 2013, the Heads of State of the CEMAC member states adopted the Common Pharmaceutical Policy (CPP) The Organization for the Fight Against Endemic Diseases in Central Africa (OCEAC) responsible for coordination of health programmes in the region North/North Eastern Africa Dec 2010: Consultation on AMRH 03-05 August 2015, Addis Ababa, Ethiopia: IGAD Conference of NMRAs and partners IGAD 2 nd Regulators Meeting, Khartoum, Sudan, April 26-27, 2016 IGAD Call for Action agreed among other things: A mechanism for collaboration and harmonization of regulation of medical products agreed in alignment with Pharmaceutical Manufacturing Plan for Africa (PMPA) and the African Medicines Regulatory Harmonization (AMRH) Initiatives of the African Union. The roles of NMRAs, IGAD Secretariat and collaboration and development partners agreed Support the development of an overarching pharmaceutical policy and the adoption of a modern legislative framework, based on the AU Model Law. 11

AU Model Law on Medical Products Regulation 2009 2010: Situation analysis Varied comprehensiveness of medicines laws, some laws outdated, mostly territorial in nature 2011: Decision by Pan-African Parliament to come up with a Model Law on Medical Product regulation: 2011-2015: Model law development process: Optional analysis and Drafting April 2015: Conclusion of regional consultation process involving 5 regions and 47 AU Member States 13-17 April 2015: Consideration by the AU Specialised Technical Committee on Health, Population and Drug Control (STC-HPDC) November 2015: Considered by the STC on Justice and Legal Affairs 30-31 January 2016: Twenty-Sixth Ordinary Session of Heads of State & Government of AU adopted the AU Model Law & called upon Member States to act as expeditiously as possible to enable the domestication of the model law at national level Countries adopted and/or adapted before AU endorsement e.g. Ivory Coast, Zimbabwe, Lesotho, United Republic of Tanzania (Zanzibar), Seychelles and the Gambia.

Partnerships between regulators, academia and/or research institutions to provide systematic and structured regulatory science training with a view to increase regulatory workforce in Africa 1 WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance; University of Ghana Medical School - RCORE in Pharmacovigilance 2 Kilimanjaro School of Pharmacy; St. Luke s Foundation Tanzania -RCORE in training in core regulatory functions 3 WHO Collaborating Centre for the Quality Assurance of Medicines NWU - Potchefstroom Campus South Africa - RCORE in Quality Assurance and Quality Control of medicines 4 Centre for Drug Discovery, Development & Production University of Ibadan Nigeria -RCORE in training in core regulatory functions 5 Medicines Control Authority of Zimbabwe (MCAZ) -RCORE in medicine registration and evaluation, Quality Assurance/Quality Control and clinical trials oversight 6 National Drug Authority (NDA), Uganda -RCORE in licensing of the manufacture, import, export, distribution and; inspection and surveillance of manufacturers, importers, wholesalers and dispensers of medicines 7 Direction General de la Pharmacie du Medicament et des Laboratoires / University of Ouagadougou Burkina Faso - RCORE in clinical trials oversight 8 Food & Drugs Authority (FDA) Ghana -RCORE in medicine evaluation and registration and clinical trials oversight 9 Pharmacy & Poisons Board (PPB) Kenya - RCORE in pharmacovigilance 10 Tanzania Food & Drugs Authority (TFDA) / School of Pharmacy MuhimbiliUniversity of Health and Allied Sciences (MUHAS) - RCORE in medicine evaluation and registration 11 National Agency for Food and Drug Administration and Control (NAFDAC) Laboratory RCORE in Quality Assurance and Quality Control of Medicines

Challenges Human resource and financial constraints at the national and regional level Heterogeneous starting point of NMRAs Sovereignty concerns related with reliance between member-states Engagement of local manufacturing industry harmonized procedures imply an alignment with WHO international quality standards with increased stringency Broad bilateral and multi-lateral partnerships

Path Forward

African Union Vision AMA Milestones: January 2015 AU Executive Council Decision on AMRH as a foundation for AMA Third AMA Task Team, 03 Dec 2016, Cape Town Legal, institutional framework and business plan drafted AUC,, WHO & NEPAD Agency Joint Secretariat WAHO / UEMOA West Africa Medicines Agency ECCAS/ OCEAC SADC/ COMESA 2018: AMA Launch IGAD / AMU / CEN-SAD EAC East African Community Medicines and Food Safety Commission African Medicines Agency 54 countries 5regions 1 continent 16

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