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Events

 

 3rd Biennial Scientific Conference on Medical Products Regulation in Africa. "Sustaining the Momentum for Regulatory Harmonization in Africa"  27th - 28th November 2017Accra, Ghana.

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National Drug Authority was represented by ;

  • Mr. Daniel Kalibbala

  • Mr. Apollo Angole 

  • Dr. Evans Tusuubira

 Introduction

The current method of capturing data in National Medicines Regulatory Authorities

(NMRA's) is variable and unreliable in Africa. Some member states like Djibouti, Somalia, South Sudan and others do not have a functioning information management system (IMS) while other member states like Ethiopia, Uganda, Nigeria, Kenya and Sudan have national IMS platforms that are not linked to regional or continental levels.


As a result, it is difficult to integrate with national (stand-alone) IMS platforms in the region. There is currently no system for sharing information between African-NMRAs.











IGAD MRH website.

 Acknowledgement

We would like to thank the organizers of the 3nd Biennial Scientific Conference on Medical Products Regulation in Africa: namely AMRH Partners, Government of Ghana, Ghana FDA, FAPMA, IFPMA and ECOWAS/WAHO. We would also like to thank in a special way Mr. Apollo Muhairwe of World Bank for agreeing to fund the portal development project. Dr. Toroitich, Dr. Fatuma and Mr. Mbugua for spearheading and advising on the project aspects and the entire IGAD secretariat.       

Harmonization and Information Sharing

To sustain the momentum for regulatory harmonization in Africa, particularly by facilitating a platform to share lessons learnt and best practices in regulatory systems strengthening, it is necessary to implement a common information management system (IMS) that links Africa. The IMS will be a useful tool for data storage and sharing especially to support NMRAs that lack basic minimum guides like a medicine products register.












IGAD information Sharing Portal  -  All countries
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Table on the portal that allows data export and printing - data for Kenya as a sample.

For example, the recently launched Information-sharing platform by IGAD is important because it allows authenticated users to collect, manage and share structured and unstructured data sets in order facilitate two way communication between IGAD-NMRAs and IGAD Secretariat while providing stepping stones for other member states that have no systems in place.

Information sharing will certainly increase mutual trust and remove operational and technical silos among NMRAs in Africa. High quality data will lead to improved and timely regulatory decision-making, work sharing among NMRAs, reduced burden of submitting applications by applicants, harmonized requirement, procedures and tools for decision making and increased access to essential medicines in the Africa. It is also important to ensure the effectiveness, efficiency and up datedness of the systems.




Country Specific Data - Data for Uganda as a sample.





Establishment of the Information Sharing Portal for NMRAs


The information sharing portal is developed in stages and having simple and measurable deliverable per stage. To achieve this IGAD-NMRAs came up with a five-milestone plan. The milestones are:

  • Portal Development for Static data sharing. This was completed on 28th April 2017 the portal address is mrh.igad.int,
  • Application Programming Interfaces (API) Based data sharing for real-time data sharing,
  • Reports exchange and simple file sharing with user authentication,
  • User Capacity Building and
  • Key Performance Indicators incorporation.

Further Information

Visit the portal at http://mrh.igad.int and directly at  http://mrh.igad.int/production/


Visit the National Drug Authority of Uganda at www.nda.or.ug and Pharmacy and Poisons Board of Kenya at pharmacyboardkenya.org


Kalibbala, Daniel - Head ICT  - NDA

Murimi, Gedion - Head ICT Department - PPB