Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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https://hdl.handle.net/10566/14971

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Browsing by Subject "Africa"

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    A critical review of the who global report on traditional and complementary medicine 2019: implications for harmonization of traditional and complementary medicine regulation in Africa.
    (University of the Western Cape, 2022) Mukeshimana, Martin Kamuhanda; Egieyeh, Samuel A
    A broad range of Traditional and Complementary Medicine (TCM) practices and products is available and accessible to the population in many countries in Africa, and worldwide. Therefore, an effective and harmonized medicines regulatory system is required for TCM. The World Health Organization (WHO, 2019) global report on TCM highlighted the progress that was globally achieved in the regulation of TCM by countries that have implemented and adopted TCM services over the past two decades. Within the African continent, the African Medicines Regulatory Harmonization (AMRH) Initiative aims to strengthen regulatory capacity, encourage harmonization of regulatory requirements, and expedite access to good quality, safe, and effective medicines. However, several studies have shown a limited capacity to regulate TCM and medical products in general, hence the need to assess. Aim: This study assessed the status of TCM regulation in some African countries and deduced how the current status can advance the harmonization efforts in Africa. Method: A desk research on the status of African countries in adopting and implementing the WHO, 2019 TCM indicators was conducted, and a qualitative descriptive approach was used to analyze the data. Results: A total of 28 African countries responded to the (WHO, 2019) global report. The results showed remarkable progress on some WHO indicators such as the National policy and the National Office for TCM. For the primary WHO indicators that are fundamental to achieving harmonization such as the regulation and monitoring of the manufacturing of herbal medicine, results showed less than 50% of implementation by African countries.
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    Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in Africa: a review of current literature
    (Universty of the Western Cape, 2024) Nkuku, Khanyisile Zachia; Egieyeh, Samuel
    Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such as radiation emitting devices and devices incorporating a substance, are held to a high standard of quality and safety. Hence, the regulation of medical devices is required to optimize their use in healthcare within Africa. To successfully transition from the existing unregulated medical device sector to a thorough regulatory framework, many nations lack both the financial and technological resources. Consequently, organizations attempting to manufacture and market medical devices confront numerous obstacles, such as navigating the regulatory frameworks of various other nations and creating sustainable business models for imported medical devices. Many nations, including countries in Africa such as South Africa, Nigeria, and Ghana, require Conformitè Europëenne (CE) marked products which can only be obtained in Europe, making it extremely costly for local African manufacturers of medical devices to bring their products onto the market in these African countries. This study examined the feasibility of establishing an African-based equivalent of Conformitè Europëenne mark (CE mark) with a similar standard to that in Europe for indigenous African medical device manufacturers. The study also explored how such African-based CE mark will encourage innovation and expand access to medical devices in Africa.
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    Mobile phone applications targeted towards medicine adherence in Africa: A systematic review
    (University of Western Cape, 2020) Masoga, Nora Makgwara; Parker, Mariam
    According to the WHO (2017), non-communicable diseases (NCDs) which include stroke, cancer, heart disease, chronic respiratory disease and diabetes is the leading cause of death and is responsible for seventy one percent of deaths worldwide. Beaglehole et al., (2009) reported that management of chronic diseases depends primarily on early detection of early disease, identification of high-risk status, interventions including pharmacological and psychosocial intercessions and long term follow up with monitoring and promotion of adherence to treatment.