1 / 19

Africa Pharma Conference 2019 Johannesburg , South Africa 04-05 June 2019

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

chaisson
Download Presentation

Africa Pharma Conference 2019 Johannesburg , South Africa 04-05 June 2019

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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)

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

  3. Context: African aspirations 8 55| AU Member States 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”. Regional economic groups recognised by African Union

  4. 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.

  5. AU Policy Frameworks 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)

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

  7. AMRH vision Today

  8. AMRH vision… Streamlined (harmonized) future Earlier approval of more medical products & vaccines 1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP)

  9. WAHO/UEMOA EAC ECCAS/OCEAC > 85% of Sub-Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels REC progress CEN-SAD/UMA/COMESA • Status • Comments • REC IGAD • Implementation • In progress • Implementation • Implementation • Preparatory Phase • EAC • CEMAC-OCEAC • WAHO/UEMOA • SADC • IGAD • Launched March 2012 • Launch Nov. 2016 • Launched Feb 2015 • Launched July 2015 • 2016 SADC AVAREF alignment with AMRH on clinical trials ethics and regulatory oversight; EAC Pharmacovigilance Project, 3S, PAVIA, PROFORMA 11

  10. 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

  11. AMRH Governance Framework African Medicines Regulators Conference (AMRC) ASSEMBLY AUC-NEPAD-WHO Joint Secretariat AMRH Partnership Platform AMRH Steering Committee NEPAD/WHO Secretariat Technical Working Groups (TWGs) FBRA TWG on Blood and Blood products APAG TWG on Pharmacovigilance TWG on Regulatory Capacity Development 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

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

  13. 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, Zimbabwe30th September – 04 0ctober 2019

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

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

More Related