Tariro Sithole's research while affiliated with University of Hertfordshire and other places

Publications (8)

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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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
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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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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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...
Article
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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
Dissolution media based on bicarbonate buffers closely mimic the environment of intestinal fluids and thus improve in vitro in vivo correlation compared to phosphate buffers. Purging gases into the medium is used as a method to stabilise bicarbonate buffers; however, this causes issues due to the disturbance of the hydrodynamics in the dissolution...
Article
Full-text available
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...

Citations

... The results of this study show that applicants perceive that there has been a high degree of success and benefit from the ZaZiBoNa initiative for applicants, patients and regulators. A similar study was conducted with regulators (15) and the responses compared. Regulators and industry commonly agreed that information sharing among regulators and harmonisation of registration requirements across the region were the top benefits of the ZaZiBoNa initiative. ...
... 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. ...
... Views of the regulators (15) and industry were compared and there was agreement on the challenges such as lack of information for applicants on country websites, failure by applicants to meet deadlines for submission of responses, Interestingly, only a minority of the regulators and industry were of the view that self-funding by countries created a sustainable resource base for this initiative; therefore, there is still a need for partner support or other sources of funding at present. This is supported by studies in the literature highlighting the inadequacy of resources currently available to authorities in lowto middle-income countries (16)(17)(18)(19)(20). Challenges highlighted by the industry but not identified in the regulators study (15) are the difficulties faced by applicants when they need to follow up on pending dossiers/applications or seek arbitration in situations in which individual authorities were uncooperative. ...
... 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). ...
... This could be due to the significantly lower resources; for example, the number of assessors, available to ZaZiBoNa countries when compared with countries in the other initiatives. Most of the active member countries in ZaZiBoNa are faced with the challenge of limited resources and a high number of applications (4,10,(15)(16)(17) for the national procedure, which negatively impacts the worksharing initiative. The use of a regional unit to coordinate assessments would also assist in addressing the identified challenges, particularly in a resource-constrained setting. ...
... 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). ...
... e most representative one was Li Gao's comment in his Yong Yao Fa Xiang that "pills are slow, soothing, and healing." Modern pharmacological studies have also confirmed the ability of solid oral agents to deliver live phages to the gastrointestinal tract [12], and the release of active ingredients from the pills was relatively slow in the intestinal fluid environment simulated by the bicarbonate buffered dissolution medium [13]. erefore, the application of pills not only allowed the active ingredients to remain in the body for a longer period of time but also allowed for more precise targeting of herbal medicine. ...