1. Africa Pharma Conference 2019
Johannesburg , South Africa 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
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”.

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 AMRH
The Abuja Declaration on ATM & other diseases (2001)
Agenda 2063
Africa Health Strategy ( )
Continental Free Trade Area (CFTA)
AMRH
AU Science, Technology, and Innovation Strategy for Africa ( ) 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
~ 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

8. 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)

11. > 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

12. 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

13. 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

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

17. 4th Scientific Conference on medical Product Regulation in Africa (SCoMRA IV); AVAREF Assembly; African Medicines Regulators Conference (AMRC) Victoria Falls, Zimbabwe 30th September – 04 0ctober 2019

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

19. شكرا
Thank you
Obrigado
Merci
Gracias
Asante