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The Parliamentary Roundtable Midrand, South Africa 25-27 March 2014 Lessons and experiences: EAC Medicines Regulatory

The Parliamentary Roundtable Midrand, South Africa 25-27 March 2014 Lessons and experiences: EAC Medicines Regulatory Harmonization (MRH) Project Mr. Paul K. Tanui, Senior Programme Officer-Technical Support AMRH/NEPAD Agency . Outline . Background

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The Parliamentary Roundtable Midrand, South Africa 25-27 March 2014 Lessons and experiences: EAC Medicines Regulatory

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  1. The Parliamentary Roundtable Midrand, South Africa 25-27 March 2014 Lessons and experiences: EAC Medicines Regulatory Harmonization (MRH) Project Mr. Paul K. Tanui, Senior Programme Officer-Technical Support AMRH/NEPAD Agency

  2. Outline • Background • EAC Medicines Registration Harmonization Project • Progress made • Next Steps • Conclusion

  3. Background • EAC is a regional intergovernmental organization of 5 Partner States • Republics of Burundi, Kenya, Rwanda, Uganda and the United Republic of Tanzania • 6 NMRAs including the Zanzibar Food and Drugs Board • Population: 135.4 million (2012) • GDP (current market prices): $84.7 billion (2012) • EAC Headquarters: Arusha, Tanzania

  4. Legal Framework on EAC Regional Cooperation on Health • Chapter 21 (Article 118) of the EAC Treaty 7th July 2000 • Provides for harmonization of drug registration and regulation • Harmonize drug registration procedures • Develop Common Drug Policy, and establish quality control capacities, good procurement practices • Harmonize national health policies and regulation to promote the exchange of information on health issues in order to achieve quality health within the Community.

  5. EAC MRH Programme • The East African Community MRH Programme was officially launched on 30th March, 2012, in Arusha, Tanzania. • Purpose: To improve access to safe, efficacious and good quality essential medicines for the treatment of conditions of public health importance • Goal: To have a harmonized and functioning medicines regulatory system in accordance with national and internationally recognized policies and standards [WHO & ICH]

  6. Milestones for the EAC MRH Programme An agreed common technical document for evaluation and registration of medicines domesticated in EAC Partner States by end of year three (3) of the programme A common integrated IMS established and linked in all EAC Partner States and EAC Secretariat by the end of year four (4) of the programme Quality management system implemented .Regional and national capacity built to implement MRH:- Three (3) NMRA’s ISO certified by the end of year five (5) of the programme

  7. Milestones for the EAC MRH Programme cont.. 4. Two regional centres of excellence in training assessors and GMP inspectors established in the EAC region by the end of year five (5) of the programme 5. Rwanda and Burundi semi-autonomous NMRA’s established by the end of year three (3) of the programme 6. EAC Regional Platform for Information Sharing on regulatory matters established by the end of year three (3) of the programme 7. EAC Legal Framework for mutual recognition of regulatory decisions developed by the end of year five (5) of the programme

  8. Implementation Arrangements for EAC MRH Programme EAC Sectoral Council of Ministers of Health NEPAD Agency • Advocacy • Coordination • EAC Sectoral Committee on Health Work Plans • Regional Annual WHO Project Steering Committee • Consolidated Budget & procurement plan • Interim Finance Reports • Guidelines for • T A • Annual Audit harmonization EAC Project Coordination Team Technical Working Groups • NMRA Annual Work Plans • Nomination of experts • Annual Budgets • Participation in • Procurement Plans consultations • Quarterly performance Reports NMRA 1 NMRA 2 NMRA 3 NMRA 4 NMRA 5 NMRA 6

  9. Progress and work covered by the 4 TWGs July 2012 to Feb 2014

  10. Graphic presentation

  11. Next steps that need to be supported • Review, update and establish a harmonized regional policy and legal framework • Establish East African Community Medicines and Food Safety Commission by 2016 • Review of the existing National Pharmaceutical Policies and Legislations in the Five (5) EAC Partner States • 9th Ordinary Sectoral Council of Ministers for Health 13th to 17th April meeting in Zanzibar to approve the draft guidelines for implementation at Partner States NMRAs • To continue developing a few pending SOPs and guidelines • Conduct stakeholders sensitization and advocacy at EAC regional level and national level in EAC Countries

  12. Conclusion • EAC MRH Programme is promising for medicines regulation harmonization and more support and advocacy should continue • Success requires continued commitment of Partner States, NMRAs and AMRH Programme Partners • Continued monitoring of success indicators will be of importance

  13. ONE PEOPLE ONE DESTINY THANK YOU ASANTE

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