Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)
http://hdl.handle.net/11394/5883
2024-03-29T05:45:11Z
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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.
http://hdl.handle.net/11394/10682
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.
Mukeshimana, Martin Kamuhanda
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.
>Magister Scientiae - MSc
2022-01-01T00:00:00Z
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Cannabidiol: A medicine, health supplement or foodstuff? Analysis of South African policies relating to the introduction of cannabidiol into the market
http://hdl.handle.net/11394/9254
Cannabidiol: A medicine, health supplement or foodstuff? Analysis of South African policies relating to the introduction of cannabidiol into the market
Boshoff, Suné
With the recent rise in the popularity of cannabidiol (CBD) around the world, there
are many cultivators, manufacturers, and sellers of CBD on the market. It is sold in
different dosage forms including oils, used to treat a wide variety of lifestyle diseases
and medical conditions. Despite the increasing availability of CBD and its products,
there are many controversies and uncertainties regarding the legality and regulation
thereof in various countries. The main question is whether CBD is regarded as a
medicine, health supplement or merely a foodstuff.
>Magister Scientiae - MSc
2022-01-01T00:00:00Z
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Situation analysis study on nanomedicines regulation and assessment practices in Zazibona active countries
http://hdl.handle.net/11394/8971
Situation analysis study on nanomedicines regulation and assessment practices in Zazibona active countries
Mudyiwenyama, Linda Gracious
Nanomedicines are loosely defined as medicines that seek to apply nanotechnology. Currently,
nanomedicines are available for clinical use, including treatments for cancer, high cholesterol,
hepatitis, COVID-19 vaccination, among other uses (Patra et al., 2018; Gao et al., 2021). Most
of the nanomedicines meet the definition of medicines according to various national
legislations. Consequently, these products are regulated as medicines. Nanomedicines present
major differences in biological details and increased complexity of clinical use. They integrate
different technology subsets from therapeutics to imaging and integrated non-invasive
diagnosis (Gaspar, 2007). These complexities require extra regulatory effort.
>Magister Scientiae - MSc
2021-01-01T00:00:00Z
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Exploration of the training/educational background and the roles of regulatory affairs associates/officers in selected South African based pharmaceutical companies in Gauteng province
http://hdl.handle.net/11394/8640
Exploration of the training/educational background and the roles of regulatory affairs associates/officers in selected South African based pharmaceutical companies in Gauteng province
Mukoma, Collins
Regulatory Affairs (RA), within the pharmaceutical business, could be a profession that covers different registration parameters of a pharmaceutical product. This is a profession that was developed to protect the public by providing smart, quality, safe and efficacious pharmaceutical products. However, it is not clear if the personnel possess the fundamental education and training required to perform the roles and responsibilities in this profession. The study aimed to explore the educational training and role of RA associates/officers in pharmaceutical corporations in Gauteng, South Africa. The study was a cross-sectional survey, which utilized Google forms with both open and closed-ended questions. Using descriptive statistics, it was found that the majority of the participants (78.3%) (RA assistants, officers, and scientists) indicated that the knowledge for most of the responsibilities they carry out was acquired through informal training (i.e., learning on the job).
Magister Pharmaceuticae - MPharm
2021-01-01T00:00:00Z