Pharmaceutical Coordinator African Medicines Regulatory - - PowerPoint PPT Presentation

Margareth Sigonda Pharmaceutical Coordinator African Medicines Regulatory Harmonization Programme (AMRH) New Partnership in African Development (NEPAD) Planning and Coordinating Agency African Union

NEPAD Planning and Coordinating Agency

African Medicines Regulatory Harmonization Initiative

…Collaboration Among Countries

CPTR Workshop, Washington DC, 24-25 September, 2014

Presentation Outline

• The AMRH Background & Vision
• AMRH Progress
• AMRH Collaborative Procedures
• Conclusion

Background

2005-2007: AU Pharmaceutical Manufacturing Plan for Africa (PMPA)

AU- PMPA AU-Roadmap

• n Shared

Responsibility & Global Solidarity for ATM response in Africa Creating an Enabling Regulatory Environme nt Pharmaceuti cal sector development

(Optimizing the African Market for new medical products and technologies)

Increased access to medical products and technologi es

The AMRH Background & Vision…

Effective and Efficient regulation of medical products:

• Investment incentive for industry
• Key for attainment of Universal Health Coverage
• Hampered by prevailing capacity limitations in Africa, World

Health Organization (WHO) Study Report 2004:

– 4% of countries with moderate capacity – 33% some capacity to carry out most functions – 24% basic capacity to carry out minimum functions – 39% of countries with limited capacity

The African Medicines Regulatory Harmonization Initiative

The African Medicine Regulatory Harmonization (AMRH) initiative aims to accelerate the access to products by improving the fragmented system of product registration in Africa Main focus

• Develop common requirements /

guidelines / format

• Work sharing among countries
• Streamlined regional decision making at

the regional level Current Partners RECs, NEPAD, WHO, World Bank, BMGF, DfID

• Initial stakeholder

engagement (NEPAD)

• Regional proposals

developed

• Multi-donor trust-

fund established

• EAC harmonization

launched

• Focus on

WAHO/UEMOA and SADC Region projects consolidation 2009 2010/ 2011 2011 2012 2013/ 2014

Vision for AMRH Programme

55 countries 1 continent

African Medicines Agency

5regions

IGAD / AMU / CEN-SAD

EAC

SADC/CO MESA ECCAS/ OCEAC WAHO / UEMOA Vision: East African Community Medicines and Food Safety Commission MRH Project launched March 2012

9/30/2014 8

Roughly 85% of Sub-Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels

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%

REC progress

SADC

We are pushing forward those RECs that are ready while continuing to work with the remaining regions

• REC
• EAC
• OCEAC/ECCAS
• WAHO/UEMOA
• SADC
• North/Northeast

Africa

• Status
• Comments
• Implementation
• In progress
• In progress
• In progress
• Ongoing discussions
• Launched 2012
• Launch of Steering

Committees Expected 2014

8 EAC ECCAS/OCEAC CEN-SAD/UMA/COMESA IGAD

EAC Plan for Joint Assessment

• Borrow the idea from WHO PQ
• Lead country, TFDA prepares a call for Expression of

Interest – with agreed list of products

– Simultaneous submission to EAC Partner States’ NMRAs – Secretariat coordinates joint assessment sessions – Country approvals of jointly accepted products

NOTE………

– EAC Harmonized guidelines for registration of medicines and GMP inspection have been approved by the Council of Ministers – 20 September 2014 – Effective date for implementation - 1st January 2015

9

In Conclusion

• AMRH provides a platform for collaboration among African

countries in the implementation of harmonised regulatory requirements and standards

• Work sharing among countries, trust building and streamlined

regional decision making at the regional level among participating member states belonging to a regional economic community is key for success

• CPTR can borrow leaf from the working models and employ the

same methodology for TB drugs

Thank You