DOI: 10.6084/m9.figshare.21275772
title: Questionnaire

description: The right to health is an international human right as stipulated in Article 25 of the Universal Declaration of Human Rights and Article 12 of the International Covenant on Economic, Social and Cultural Rights [1]. This right is also affirmed in Article 16 of the African Charter on Human and Peoples Rights. States Parties are obligated to protect the health of their population, and the State must improve access to good quality medicines for better treatment outcomes. Regulation of medical products assures quality, safety, and efficacy. It promotes and protects public health, resulting in better health outcomes. The African Union Assembly Decision {Assembly/AU/Dec.55(IV)} taken during the Abuja Summit in January 2005 requested the Africa Union (AU) Commission to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of the then New Partnership for Africa’s Development (NEPAD) [2]. The Africa Medicines Regulatory Harmonization (AMRH) Multi-Donor Trust Fund was established in 2011 by World Bank to help support regional harmonization efforts to remove barriers that hinder access to quality medicines. Managed by the AMRH, its primary objective is “to promote the harmonization of medicines regulation, to increase access to essential and quality medicines, by strengthening governance and regulatory systems of the pharmaceutical sector 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 [3]. The roadmap emphasizes the need to accelerate and strengthen regional medicines regulatory harmonization initiatives and lay the foundation for the African Medicines Agency (AMA). Since 2012, AMRH has been active in East, West, Southern Africa, and the Horn of Africa, assisting in their regional consensus-building efforts to harmonize requirements across countries, increase collaboration, strengthen regulatory capacity, and accelerate the registration of quality medicines. In 2015 the Executive Council Decision {(EX.CL/Dec.857 (XXVI)} endorsed the milestones for establishing the AMA in Africa within the context of the AMRH Initiative. The AMRH contributes to the PMPA and the development of human health capital to fulfill the African Union’s human and social development enshrined in Agenda 2063 [4]. The AMRH is also committed to the fulfillment of the vision of AMA. The goal of AMA is to ensure the coordination and strengthening of continental initiatives to harmonize medical products regulation, provide guidance and technical support to improve access to quality, safe and efficacious medical products and health technologies on the continent [5]. AMA will work within the continental architecture of Regional Economic Communities (REC) and Regional Health Organizations (RHOs) to support the AU Member States. In preparation for the establishment of the AMA, there is a need to connect and link the information management systems for medicines regulation on the continent. While some countries have robust information systems solutions for medicines regulation, others have nothing. This is further compounded by very few RECs having functional regional information systems solutions for ensuring that the less-resourced countries can tap into regulatory data, which is essential for ensuring the quality of medicines in their markets. This information gap underscores that more work needs to be done to fully realize our collective goals toward a more harmonized future for medicine regulatory harmonization in Africa [5]. To facilitate decision-making and information sharing amongst the member states and stakeholders, an integrated continental IMS will have to be developed for the continent by ensuring interoperability. In regions where there are no Regional Regulatory Information Management Systems (Regional-RIMS), building or establishing systems for Regional-IMS solutions will enable information sharing not only among countries in those regions but also across countries on the continent. Information sharing will enhance the gains of medicine regulatory harmonization. Furthermore, the technical aspects of medicine regulation and decision-making must also be supported by robust Regional-RIMS and Continental Regulatory Information Management System (Continental-RIMS) solutions. Hence, an integrated Continental-RIMS at the continental level connecting the Regional-RIMS and National Medicines Regulatory Agencies (NMRAs) will be an essential means of ensuring speedy access to medical products that are safe, efficacious, and of assured quality, to the African population as well as information on the same. A critical first step in establishing a Regional-RIMS and, ultimately, a Continental-RIMS solution is to assess the current Information Management System (IMS) solutions at national and regional levels and recommend specifications for a system, and scope the activities needed to operationalize the solution. In March 2020, the World Bank contracted Bewsys Limited, an Information Technology (IT) Consulting firm, to scope the current IMS solutions at 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. The advice from the scoping should provide the basis for policy dialogue at the AU, including the envisaged AMA as a continental medicines regulatory agency. This report by Bewsys Limited provides an assessment of medicine regulatory functions, the current IMS solutions, and supporting infrastructure in operationalizing the processes in the African states. It also proposed system requirements and a roadmap to establish the continent-wide integrated IMS solution to provide online real-time medicine regulation information and support workflow management in Africa.