Browsing by Author "Gwaza, Luther"

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    Perspectives on systematic capacity building in pharmaceutical regulation for regulators of medical products
    (Frontiers Media, 2024) Dube, Admire; Gwaza, Luther; Chemwolo, Andrew
    Having a robust, integrated regulatory system is important for ensuring the availability of safe and efficacious medical products of good quality and for protecting public health. However, less than 30% of countries globally have reached the required regulatory maturity level three, with low- and middle-income countries facing challenges in attracting and retaining qualified staff. World Health Organization (WHO) advocates for systematic workforce development, including competency-based education, to address these gaps. We provide perspectives on a systematic approach to capacity building of medicine regulators based on the experience and lessons learnt in developing and piloting the WHO global competency framework for medicine regulators through three scenarios. A systematic approach to capacity building, such as the human performance technology model, can be used to implement the WHO competency framework as part of organizational performance improvement while ensuring that initiatives are well-defined, targeted, and aligned with organizational goals. The competency framework can be used in different contexts, such as improving organization performance for individual regulatory authorities, strengthening regional collaborations, harmonization and reliance on medical products assessment and joint good manufacturing practices inspections of pharmaceutical manufacturers, and developing learning programs for medicine regulators. A competency-based learning approach for regulatory professionals ensures the transfer of learning to the workplace by integrating real-world practices in learning activities and assessments. Further work is required to develop and validate the assessment instruments, apply the competency framework in other contexts, expanding the learning programmes while continuously providing feedback for further refinement of the competency framework and implementation support tools.
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    The transition of regulatory services from drug regulatory unit to Botswana medicines regulatory authority: an evaluation of the changes in regulatory services from the industry’s perspective
    (University of the Western Cape, 2023) Maloisane, Rebecca M; Egieyeh, Samuel; Gwaza, Luther
    The Drug Regulatory Unit (DRU) was established by the Ministry of Health (MoH) to enforce the Drugs and Related Substances Act of 1992 in line with the Botswana National Drug Policy (BNDP) adopted in 2002 and the National Health Policy (NHP) to attain health for all. However, as with many National Regulation Authorities (NRAs) in low and middle-income countries, the DRU had major challenges in inefficient legislation and regulation to address the supply of substandard and falsified medicines, and financial and human resource constraints to maintain and sustain regulatory oversight. The Government of Botswana through the MoH restructured DRU into a semi-autonomous regulatory body, Botswana Medicines Regulatory Authority (BOMRA). To aid the NRAs in building and strengthening regulatory systems' capacity to regulate medicinal products effectively and efficiently, the World Health Organization (WHO) has generated a Global Benchmarking Tool (GBT) for member states. As of December 2019, a total of 26 countries underwent formal benchmarking while 54 countries including Botswana completed self-assessments using the WHO-GBT. Despite this self-assessment, there might be a need to assess the efficiency of the regulatory service delivery of BOMRA from the industry’s perspective. The study aimed to assess and compare the changes in the regulatory system for the WHO-recommended regulatory functions and service delivery following the transition of DRU to BOMRA from the industry’s perspective.