Africa Pharma Conference 2019 Johannesburg , South Africa 04-05 June 2019 African Medicines Regulatory Harmonization (AMRH) Paul Tanui Senior Programme Officer-Technical Support, AMRH AUDA-NEPAD African Union Development Agency (AUDA-NEPAD)

OUTLINE Context: African Aspirations Continental Policy & Regulatory Frameworks The African Medicines Regulatory Harmonization Progress made Africa Medicines Agency

Context: African aspirations Regional economic groups recognised by African Union 55| AU Member States 8 1.13 billion Number of people on the African Continent 5 AU geographic regions Agenda 2063 Aspiration 1: A Prosperous Africa, based on Inclusive Growth and Sustainable Development Goal 1: A high standard of living, quality of life and wellbeing for all citizens Goal 3: Healthy and well-nourished citizens “achieve access to safe, effective, quality and affordable essential medicines and vaccines for all”.

AUDA Mandate Co-ordinate the implementation of priority continental and regional projects to promote regional integration. Strengthen the capacity of AU Members States and regional bodies to implement Africa’s priority development programs within the framework of Agenda 2063. Provide knowledge-based and technical advisory support to AU Member States and regional economic communities for the implementation of AU common policies and strategies. Monitor and evaluate the implementation of Africa’s development programs for best practice and sharing lessons to promote sustainable development. Serve as the continent’s technical interface with Africa’s development stakeholders, including development partners, for integrated and inclusive development.

AU Policy Frameworks AMRH The Abuja Declaration on ATM & other diseases (2001) Agenda 2063 Africa Health Strategy (2016-2030) Continental Free Trade Area (CFTA) AMRH AU Science, Technology, and Innovation Strategy for Africa (2014-2024) in short STISA:2024 Pharmaceutical Manufacturing Plan for Africa (PMPA) --Business Plan (2012) AU Catalytic Framework to end AIDS, TB and Eliminate Malaria in Africa By 2030 Program for accelerated Industrial Development of Africa (AIDA)

PMPA 2005: AU Decision55 on development of the Pharmaceutical Manufacturing Plan for Africa (PMPA) within the NEPAD Framework

AMRH vision Today ~ 55 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation across Africa Regulators' capacity highly variable, some with almost no capacity at all Different requirements and formats, lack of clear guidelines Minimal transparency, No clear timelines Reference evaluations (1) underleveraged

Streamlined (harmonized) future AMRH vision… Streamlined (harmonized) future Between 5-7 regional economic communities (RECs) covering the entire African continent1 Stronger, institutionalized regulatory capacity & systems strengthening programmes Single set of requirements, Clear guidelines, Fewer dossiers to prepare (one per REC) Transparent regulatory processes with clear timelines Resource pooling and information sharing Faster registration Earlier approval of more medical products & vaccines 1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP)

> 85% of Sub-Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels REC progress WAHO/UEMOA EAC ECCAS/OCEAC CEN-SAD/UMA/COMESA Status REC Comments IGAD EAC CEMAC-OCEAC WAHO/UEMOA SADC IGAD Implementation In progress Preparatory Phase Launched March 2012 Launch Nov. 2016 Launched Feb 2015 Launched July 2015 2016 Completed or in-process RECs Countries covered Total members* % pop covered EAC & OCEAC EAC, OCEAC, ECOWAS EAC, OCEAC, ECOWAS, SADC 12 (20%) 26 (46%) 41 (74%) 11 26 41 17% 45% 72% While EAC has made progress in the development of harmonized guidelines for registration, GMP inspection, quality management system and information management system, West African (ECOWAS/UEMOA) and Southern African (SADC) regions are to launch their MRH Project Steering Committees before end of 2014 SADC AVAREF alignment with AMRH on clinical trials ethics and regulatory oversight; EAC Pharmacovigilance Project, 3S, PAVIA, PROFORMA 11

AMRH transition into the African Medicines Agency The AU Executive Council Decision, {EX.CL/Dec.857 (XXVI))} in January 2015 which endorsed the Milestones for the setting up of a single medicines regulatory agency in Africa within the context of the AMRH Initiative, and as part of the PMPA Framework 11 February 2019; AU Summit adopted a Treaty for establishment of the African Medicines Agency Q3-Q4 Advocacy for ratification by at least 15 member States

AMRH Governance Framework African Medicines Regulators Conference (AMRC) ASSEMBLY AMRH Partnership Platform AUC-NEPAD-WHO Joint Secretariat AMRH Steering Committee NEPAD/WHO Secretariat Technical Working Groups (TWGs) TWG on Regulatory Capacity Development APAG TWG on Pharmacovigilance FBRA TWG on Blood and Blood products TWG on Medicines Policy and Regulatory Reforms AVAREF TWG on Clinic Trials TWG on GMP AMQF TWG on Market Surveillance PAHWP TWG on Medical Devices

AMRH Partnership Platform (Africa Chapter of WHO-coordinated Global CIP and TWGs)

4th Scientific Conference on medical Product Regulation in Africa (SCoMRA IV); http://www.nepad.org/scientificconference/ AVAREF Assembly; African Medicines Regulators Conference (AMRC) Victoria Falls, Zimbabwe 30th September – 04 0ctober 2019

If you want to go quickly, go alone. If you want to go far, go together. ~ African proverb

شكرا Thank you Obrigado Merci Gracias Asante www.nepad.org