Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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Browsing by Author "Egieyeh, Samuel A"

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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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    Monitoring and evaluation of medical products regulatory systems and harmonization in west Africa
    (University of the Western Cape, 2023) Hettige, Navoda Lakshani; Egieyeh, Samuel A
    The Food & Drug Authority (FDA) defined regulatory harmonization as a process where regulatory agencies align technical guidelines for marketing and the development of pharmaceutical products all over the world. Regulatory harmonization can increase efficiencies in regulatory agencies worldwide and reduce duplication of efforts. The African Medicines Regulatory Harmonization (AMRH) initiative is recognized as the bedrock of medicine regulations in the African region. As the first step, the AMRH initiative established the East African Community Medicines Regulation Harmonization (EAC-MRH) program in 2012 in the East African Community (EAC). The Medicines Regulatory Harmonization project harmonized the different aspects and legal frameworks within that regional economic community and proposed a reliance model for medicine registration. As a result, there was increased access to quality medicines and the emergence of medicine manufacturers in Africa. In 2015, the AMRH initiative established the Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) program in Ghana to enhance medicine regulation in West Africa with the collaboration of the World Health Organization (WHO) and the New Partnership for Africa's Development (AUDA-NEPAD). The AMRH initiative conducts monitoring & evaluation studies to assess the performance of quality management systems (QMS), good manufacturing practices (GMP), information management systems (IMS), and registration systems in national medicines regulatory authorities of countries within a respective regional economic community. This study aimed to analyze the monitoring and evaluating data from the ongoing implementation of the Medicines Regulatory Authorities’ (MRAs) regulatory systems and harmonization program in the ECOWAS region by AUDA-NEPAD. The data were collected by administering a previously validated questionnaire to the heads of the departments in each National Medicines Regulatory Authority (NMRA) and Regional Economic Community (REC) Secretariat. The questionnaire was designed based on nine categories following the WHO Global Benchmarking Tool (GBT). All these nine categories were further divided into sixteen indicators for ease of understanding. This project used the data collected by AUDA-NEPAD as a secondary data source. The data collected were qualitative and quantitative; therefore, a mixed-method approach was used to analyze the data.