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Africa’s centralised medicine regulatory MIS requirements gathering

World Bank / AU - Establishing system requirements to improve access to quality, safe and efficacious medical products and health technologies on the continent.

SDG 3 - Good Health And Well-Being

Project Detail

Background

To improve access to good quality medicines and ensure regulation of medical products assure quality, safety, and contribute to the promotion and protection of public health and better health outcomes, the African Medicines Agency (AMA) under the jurisdiction of the Africa Medicines Regulatory Harmonisation Multi-Donor Trust Fund (AMRH) and the African Union (AU), with financial support from the World Bank, sought to establish a continental management information system to help facilitate the sharing of regulatory data and information on medicines among countries in Africa.

In 2012, the 19th African Union Assembly Decision {Assembly AU/Dec.442(XIX)} on the AU Roadmap for Shared Responsibility and Global Solidarity for the AIDS, TB and Malaria response in Africa was adopted. This roadmap emphasised the need to accelerate and strengthen regional medicine regulatory harmonisation initiatives and lay the foundation for the AMA.

The AMRH was established in 2011 to help support this objective by harnessing regional harmonisation efforts to remove barriers that hinder access to quality medicines. Managed by the World Bank, the AMRH has successfully increased collaboration, strengthened regulatory capacity, and accelerated registration of quality medicines by harmonising requirements across countries in East, West, and Southern Africa. The AMA was introduced to provide guidance and technical support to improve access to quality, safe and efficacious medical products and health technologies on the continent. While some countries had IMS systems in place for medicines regulation, others had nothing.

To facilitate decision making and information sharing amongst Member States and stakeholders within the continent, there was a need to link the information management systems (IMS) for medicines regulation for interoperability. 


Solution

Bewsys was contracted by the World Bank Group to scope the existing IMS at both the national and regional levels and make policy and technical recommendations on potential solutions to facilitate the sharing of regulatory data and information on medicines among countries in Africa. In delivering the requirements of this task, the consulting team assessed the existing Regulatory Information Management System solutions and associated supporting infrastructure in all the Member States’ National Medicines Regulatory Authorities (NMRAs).

A situational analysis was conducted on existing continental e-governance initiatives and/or platforms in the health sector in the AU and AU Member States to access the interoperability of the requirements specifications for the continental IMS with existing continental platforms.

The team also reviewed country policies and regulatory frameworks to propose policy considerations necessary for a regional and continental IMS. The data collated helped the team to build a roadmap for the proposed IMS that was intended to enable information sharing among and across countries on the continent. The technical team also provided a comprehensive report that outlined the technical, user requirements, and specifications for the suggested IMS for medicine regulation that linked the NMRAs in their respective RECs and the continent-wide R-MIS.

The report highlighted modules such as the Product Registration; Inspections Module for both GDP and GMP; Laboratory Information Management System; Pharmacovigilance; Clinical Trials; Import and Export; Licensure – Professionals and Premises; Track and Trace; Monitoring and Evaluation; Finance modules. In working closely with the World Bank and New Partnership for Africa’s Development (NEPAD teams), the Bewsys team successfully presented an executive report highlighting the basis for policy dialogue at the AU and how it positions the AMA as a single continental medicines regulatory agency.


Impact

The recommendations from the Bewsys consulting team provided a guideline to the AU on the best solution to adopt in facilitating the sharing of regulatory data and information on medicines among countries in Africa. This is a crucial step in establishing a continental IMS that can support the less-resourced countries to tap into functional regional regulatory data. This focuses on sustainably achieving good health and wellbeing and access to quality long term treatment within the African continent.

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