Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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Browsing by Author "Dube, Admire"

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    A Comprehensive Study on the Global Regulatory Requirements for the submission of a Post-Approval Change, specifically a Change in Manufacturing Site
    (University of the Western Cape, 2017) Hoey, Barbara; Dube, Admire
    Regulatory requirements for post-approval changes vary for different countries around the world. It is a challenging and costly process for pharmaceutical companies to manage changes to the approved regulatory dossier over the lifecycle of the product when it is registered in many countries. In practice the process can be complex, unpredictable and time consuming because of regional differences and frequent changes in regulatory procedures, requirements and timelines. The global regulatory requirements for the submission of a post-approval change, specifically a change in manufacturing site, were reviewed for six jurisdictions for this study. These include United States of America (US), Europe (EU), South Africa, Brazil, Russia and China. The study centred on the differences in the documentation required when submitting a post-approval change for a change in manufacturing site in these countries. The study compared and contrasted the differences and similarities between the jurisdictions. An analysis of the challenges for implementation of the change was performed. The study also examined what resources a company may need in order to meet the requirements. Some notable similarities but also many differences in the post-approval submission requirements between the countries were identified. Some of the similarities included classification of the type of variation, the submission application process, and the requirement to provide supportive stability data and updates to the common technical dossier (CTD). Differences highlighted were the types of application forms required, the amount of stability data required to support the change and the time lines for review of post-approval changes in each jurisdiction. The challenge for pharmaceutical companies arises in the effective management of these differences. Investment in a robust regulatory change management team is an essential resource requirement for pharmaceutical companies. Adoption of a QbD approach and careful consideration of the global requirements during the product development phase could potentially be of use in strategic planning within a company in order to ensure continued product access globally.
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    Ongoing development of guidelines for biosimilar medicines assessment in Uganda: Critical evaluation and recommendations for inclusion
    (University of Western Cape, 2020) Nantongo, Eva; Dube, Admire
    A Biosimilar is defined as a biologic product that is similar but not identical to the reference/originator biologic product. Biologic products have raised hopes of improving the quality of life especially in the treatment of chronic non-communicable diseases (NCDs). Of all the major health threats to emerge since the start of this century, none has challenged the very foundations of public health as profoundly as the rise of NCDs. However, the increasing cost of treatment of biologic products has raised many questions regarding its access in the context of multiple inequalities. The arrival of the patent cliff in this sector has given rise to biosimilars. The emergence of biosimilars is expected to go a long way in reducing the cost of care of NCDs. The use of biosimilars is based on the assumption that they are of assured quality and of the same pharmaceutical standard as the reference biologicals. Their quality should therefore be rigorously controlled and assured. Uganda has had biologicals on its market that are claimed to be copies of the originator biologicals also known as biosimilars. Most of these products have not been approved through a biosimilar approval procedure, but have instead been licensed (by the Uganda National Drug Authority (NDA)) using the same requirements as generics or small molecule medicines. According to the World Health Organization (WHO) Guidelines on the Evaluation of Similar Biotherapeutic Products, a biosimilar that has not been demonstrated to be similar to a reference product through head-to-head comparisons should not be described as similar or be called a biosimilar. Although these products are on the Ugandan market, based on the above, they cannot be referred to as biosimilars. In November 2017 however, NDA embarked on the process of developing guidelines for assessment of biologics, and a specific guideline for assessment of biosimilars.
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    Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)
    (University of the Western Cape, 2021) Dhanraj, Keshnee; Dube, Admire; Ward, Kim
    Medicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources at national medicines regulatory authorities (NMRAs) and some countries have adopted unified approaches to medicines registration legislation. Harmonised guidelines and initiatives have been adopted in South Africa and the Southern African Development Community (SADC). However, there are no studies that have identified the effects of these initiatives and guidelines on major stakeholders such as the pharmaceutical industry and regulators.
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    Situation analysis study on nanomedicines regulation and assessment practices in Zazibona active countries
    (University of Western Cape, 2021) Mudyiwenyama, Linda Gracious; Dube, Admire
    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.