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Scoping requirements for harmonised medicine regulatory MIS for SADC

World Bank / SADC -  Scoping system requirements for harmonised Southern African Development Community (SADC) medicine regulatory to increase access to safe, effective, and affordable essential medicines of acceptable quality.

SDG 3 - Good Health And Well-Being

Project Detail

Background

To increase access to safe, effective, and affordable essential medicines of acceptable quality, and protect public health, the Southern African Development Community (SADC) through its African Medicines Regulatory Harmonization (AMRH) initiative sought to implement effective medicines regulatory systems within the SADC region.

The SADC consists of 16 member states (Angola, Botswana, Union of Comoros, Democratic Republic of Congo (DRC), Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, eSwatini, Tanzania, Zambia, and Zimbabwe).

In 1999, the SADC Council of Ministers approved the harmonization of medicines regulation in the region in line with Article 29 of the Protocol on Health. This gave birth to the AMRH initiative (SADC MRH project) which focused on building effective medicines regulatory systems within the SADC region. The SADC Member States were at varying levels of development in terms of organizing and sharing regulatory information.

To achieve this goal, there was a need for the SADC MRH to put in place a system for sharing information to enhance the gains of medicines regulatory harmonization. 


Solution

Bewsys was contracted by the World Bank Group to develop system requirements for a web-based, e-Governance (e-Gov)  and to scope the activities needed to put the e-Gov in place. The team conducted a comparative study of existing e-Gov and Infrastructure to identify specific technical and user requirements needed to establish the most efficient e-Gov for the region.

During the study, the team worked in close collaboration with the National Medicines Regulatory Authorities (NMRAs) in all the member states to enable the team to produce a detailed roadmap implementation plan for the suggested solution.

The Bewsys consulting team considered the online and real-time availability of medicine regulation information in the process of generating recommendations for the best-fit e-Gov. The feasibility report that was prepared highlighted a proposed solution that will be built on the existing platforms and made room for compatibility and workflow processing. 


Impact

The proposed solution suggested to the SADC MRH by the Bewsys consulting team provided a structured roadmap for the SADC region to develop and implement an integrated IMS to enhance decision making and information sharing within the AMRH initiative.

This proposed solution sets the tone for policy dialogue and frameworks to create the much-needed harmonised medicine regulatory systems. This is a step in achieving sustainable access to safe and quality medicines across the SADC region.

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Testimonials

FAO

Working with Bewsys has been a tremendous journey. We have not reached our destination, but we are enjoying the ride. Although it was supposed to be a corporate function, at meetings, we built rapport and trust with the consultants, and at the same time, they enhanced efficiency and collaboration.

World Cocoa Foundation (WCF)

Bewsys sure knows what it’s about. I’m particularly thrilled with the use of technology to accomplish tasks and also with the packaging of deliverables.

Proforest

Great service. I will recommend any day anytime.

USAID

The Bewsys team worked professionally on our assignment and sought to deliver our needs with great patience and creativity. They are reliable, competent and I recommend them for any assignment.Bewsys sure knows what it’s about. I’m particularly thrilled with the use of technology to accomplish tasks and also with the packaging of deliverables.

Chemonics

Very professional in their work, and client communication. I was really impressed with their ability to meet all their deliverable schedules, and above all submit a comprehensive user manual. Will recommend them to other projects.

UNDP Phillipines

Bewsys has been able to deliver what was expected based on the agreed timelines. The inception mission in the Philippines has been successful, and discussions with various stakeholders have been fruitful. Bewsys showed eagerness to know more about the unique requirements of the portal upon hearing it from firsthand users. They were able to accommodate various questions, comments, suggestions, and recommendations with different stakeholders, mostly from the government side, with each agency with unique requirements.

International Organisation for Migration (IOM)

Bewsys staff are results-oriented and adapted a lot of tasks, and were flexible to ensure the solution they provided was the best. A feather in their cap!

Association of African Universities

There is a great need for digital systems development in Africa. I think it will be essential to continue supporting institutions such as Bewsys so they can do these jobs better. Also, we need to think about solutions that can be deployed quickly to support other institutions where there is a match in need.