Gugu Mahlangu's research while affiliated with Zimbabwe Revenue Authority (ZIMRA) and other places

Publications (14)

Article
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Introduction The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African D...
Article
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Introduction ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active member...
Article
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Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems of comparable size provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients' access to medicines. The aim of this study was to compare the medicines registration process of the M...
Article
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Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and...
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Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern Afric...
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There is a critical skills gap on the African continent in regulatory sciences, and an acknowledged need to develop a long‐term strategy for training and professional development of African regulatory personnel. Capacity building programs for African regulators should link education, training and research with career development in an approach that...
Article
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Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development C...
Preprint
There is a critical skills gap on the African continent in regulatory sciences, and an acknowledged need to develop a long-term strategy for training and professional development of African regulatory personnel. Capacity building programs for African regulators should link education, training and research with career development in an approach that...
Article
Full-text available
Purpose The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges an...
Article
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Background: Access to quality-assured, safe and efficacious medical products is fundamental for Universal Health Coverage and attaining Sustainable Development Goal 3: Ensure Healthy Lives and Well-being for All. To guarantee this right, there is a need for robust and efficiently performing national regulatory systems for the regulation of medical...
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Substandard and/or falsified medical products may result in treatment failure and/or death. The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiativ...
Article
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The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, reflects on what has been realized in six years of operation and what still needs to be achieved. Statistics...
Article
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Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually....

Citations

... Following the successful assessment of the ZaZiBoNa and EAC-MRH initiatives in 2021 and the impending launch of the African Medicines Agency, it is timely that the WA-MRH initiative is assessed at this time and hence the implementation of this study (Sithole et al., 2022;Ngum et al., 2022). The study aimed to assess the effectiveness and efficiency of the West Africa Medicines Regulatory Harmonization Initiative by the member countries. ...
... Gene therapy, cell therapy, and tissue engineering, known as "advanced therapies" are the new frontiers for personalized treatments for currently untreatable diseases [1][2][3][4][5][6]. Respective Advanced Therapy Medicinal Products (ATMPs) are biopharmaceuticals, whose development is associated with novel challenges for production, quality control (QC), transport, storage and application [7][8][9]. Even when ATMPs are often produced for one production and transplantation within 60 min, a proof-of-principle study in rabbits has been performed; the rabbit has been chosen as model due to comparable size of the eye. ...
... Six authorities studied by Sithole and colleagues are using reliance (verification and abridged reviews) and this will hopefully improve access to medical products in these countries (Sithole et al., 2021a). Another comparative study of the registration process of the medicines control authority of Zimbabwe (MCAZ) with Australia, Canada, Singapore, and Switzerland indicated that reliance is key in agencies that rely mainly on industry fees for sustainability like MCAZ (Sithole et al., 2021b). These authorities are already demanding a high fee for applications for products to enter the market and do not have the opportunity to increase these fees again to support resources for regulatory reviews. ...
... This presents NRAs in Africa with the difficult task of performing benefit-risk assessments using incomplete safety and efficacy data in the African population [5]. The limited staff in some African NRAs also perform multiple roles and one reviewer can be responsible for the review of quality, pre-clinical and clinical data [5,24]. ...
... The review and registration of medical products is one of the key functions of regulatory authorities that influences access to medical products (Sithole et al., 2021a). There are several bottlenecks that impact the registration of medical products in African countries by pharmaceutical companies (Narsai et al., 2012). ...
... Although a specialised field that advances public health and ensures sustainable drug innovation, regulatory science faces challenges due to inflexible recruitment processes, an absence of career structure, job descriptions that do not sufficiently detail the required competencies for positions, incoherent or impromptu regulatory workforce trainings, lack of incentives, and a brain drain [2,3]. There are also limited opportunities for training in regulatory science in Africa as evidenced by the few academic institutions that provide postgraduate regulatory science programmes and the human resource supply from such programmes is inadequate [2,4,5]. ...
... After submission, the application goes through the screening process and a response is sent within 90 days of receipt. In cases where the product fails the screening, the applicant is required to submit additional information before a substantive review of the application [4]. Product applications that pass screening progress to the evaluation stage. ...
... Previous studies reported that regulatory authorities in African countries have similar challenges to effectively undertaking core regulatory functions. (1,28) In addition to regulating local manufacturers and importers, strengthening the regulatory system is essential to prevent the circulation of counterfeit and substandard products in the light of increasing risk and the porous nature of the region. Because of the crossborder nature of the pharmaceutical business and regulatory functions, initiatives for harmonizing regulatory standards and functions have been started in different regions including Africa. ...
... The presence of nitrosamine impurities may also affect medicine shortages due to imposed embargos whilst reviews are conducted. The ZaZiBoNa collaborative medicines registration initiative was established in 2013 to facilitate work-sharing between NRAs in SADC to reduce duplication of efforts and facilitate access to medical products for the public (17). Countries actively participating in ZaZiBoNa include Zambia, Zimbabwe, Botswana, Namibia, South Africa, Democratic Republic of Congo, Tanzania, Malawi, and Mozambique, with other countries, namely; Angola, Seychelles, Swaziland, and Madagascar, participating as non-active members/observers (17). ...