Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices

Sithole, Tariro; Salek, Sam; Mahlangu, Gugu; Walker, Stuart

doi:10.1080/17512433.2022.1987883

Cited by 7 publications

(17 citation statements)

References 25 publications

(41 reference statements)

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“…Our findings on observations of poor-quality PPE and COVID-19-related medical products in Zimbabwe are consistent with evidence of increased circulation of substandard and falsified medical products in past pandemics,4 and several recent studies which have highlighted the risks of substandard and falsified medical products from the current COVID-19 pandemic 3 4 35–37. Given Zimbabwe’s stringent regulatory authority,25 26 many participants perceived that the quality of other essential medical products, besides COVID-19-related medical products, had been maintained during the pandemic. However, this may not be the case in other countries where there are less stringent regulatory authorities and where there are reports of other substandard and falsified medical products in addition to PPEs and COVID-19-related medical products 2 4 38.…”

Section: Discussionsupporting

confidence: 86%

“…Zimbabwe, an LMIC in Southern Africa, has a strong technical capacity for medical product quality assurance. This is evidenced by Zimbabwe having one of the few WHO prequalified national medical product quality control laboratories in sub-Saharan Africa 23–25. Zimbabwe’s NMRA, the Medicines Control Authority of Zimbabwe, is recognised as a regional centre of regulatory excellence by the African Union and provides training to other regulators in the region 26 27.…”

Section: Introductionmentioning

confidence: 99%

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Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

et al. 2023

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ObjectiveTo explore the impact of the Coronavirus disease 2019 (COVID-19) pandemic on the quality of medical products in Zimbabwe, including market risks for substandard and falsified products and impacts on quality assurance activities.DesignQualitative study based on in-depth key informant interviews.SettingHealth system stakeholders across the medical product supply chain in Zimbabwe.Participants36 key informants were interviewed between April and June 2021.ResultsWe found that the COVID-19 pandemic disrupted quality assurance and regulatory activities of medical products in Zimbabwe, resulted in observations of poor-quality personal protective equipment (PPE) and other COVID-19-related products and led to increased risks to quality. Risks to quality due to COVID-19-related disruptions included increased layers of agents in the supply chain and an influx of non-traditional suppliers. COVID-19-related movement restrictions reduced access to health facilities and thus may have increased the usage of the informal market where smuggled and unregistered medical products are sold with less oversight by the regulator. Most reports of poor-quality medical products were for PPE, such as masks and infrared thermometers, used for the COVID-19 response. Besides these reports, many participants stated that the quality of essential medicines in the formal sector, not related to COVID-19, had largely been maintained during the pandemic due to the regulator’s stringent quality assurance process. Incentives for suppliers to maintain quality to retain large donor-funded contracts, and the need for local wholesalers and distributors to comply with quality-related aspects of distribution agreements with global manufacturers of brand-name medical products, mitigated threats to quality.ConclusionsThe COVID-19 pandemic presented opportunities and market risks for circulation of substandard and falsified medical products in Zimbabwe. There is a need for policymakers to invest in measures to safeguard the quality of medical products during emergencies and to build resiliency against future supply chain shocks.

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Section: Discussionsupporting

confidence: 86%

Section: Introductionmentioning

confidence: 99%

Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

et al. 2023

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“…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 low- to middle-income countries ( 16 – 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.…”

Section: Discussionmentioning

confidence: 74%

Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

et al. 2022

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IntroductionThe 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 Development Community ZaZiBoNa, established in 2013. A recent study was carried out with the nine active member regulatory authorities of the ZaZiBoNa to determine their views on its operational effectiveness and efficiency. Having obtained the authorities’ views, the aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative including the challenges it faces as well as identifying opportunities for improvement from the applicants’ perspective.MethodsApplicants who had submitted registration/marketing authorisation applications for assessment under the ZaZiBoNa initiative during 2017–2021 were recruited into the study. Data was collected in 2021 using the Process, Effectiveness and Efficiency rating questionnaire (PEER-IND) developed by the authors. The questionnaire was completed by a representative responsible for ZaZiBoNa submissions in each company.ResultsThe pharmaceutical industry was of the view that the ZaZiBoNa initiative has achieved shorter timelines for approval of medicines, resulting in increased availability of quality-assured medicines for patients in the SADC region. Harmonisation of registration requirements and joint reviews have reduced the workload for both the pharmaceutical industry and the regulatory authorities. Some of the challenges identified were the lack of a centralised submission and tracking system, and the lack of information for applicants on the process for submission of ZaZiBoNa dossiers/applications in the individual countries, including contact details of the focal person. The establishment of a regional unit hosted in one of the member countries to centrally receive and track ZaZiBoNa dossiers/applications was identified as the best strategy for moving forward in the interim with the long-term goal being the establishment of a regional medicines authority.ConclusionThere was consensus between the pharmaceutical industry and the regulatory authorities as to the way forward to improve the effectiveness and efficiency of the ZaZiBoNa initiative. Implementation of the recommendations identified in this study will lead to enhanced regulatory performance.

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“…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.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward

et al. 2022

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Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspect pharmaceutical manufacturing sites and streamline decision-making processes. This initiative enables the cost-effective use of limited resources and efficient and effective delivery of regulatory services to be determined, thus instilling transparency and accountability in all stakeholders, optimising the pharmaceutical market and economic development and improving access to safe, high-quality, effective medicines in the region. The aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative, including challenges faced and to identify opportunities for improvement.Methods: The Process Effectiveness and Efficiency Rating (PEER) questionnaire, which was used to identify the benefits, challenges, and suggestions for improving performance of EAC-MRH initiative, was completed by assessors representing seven EAC authorities in the joint assessment procedure. Semi-structured interviews were also carried out to validate the responses.Results: This initiative has been of considerable value as it moves toward achieving its main objectives of shorter timelines for approval of medicines, information sharing among regulators and capacity building for assessments, resulting in quicker access and increased availability of medicines for patients in the region. However, the key challenges identified that have hindered effectiveness and efficiency were the lack of a centralised submission and tracking system; inadequate human resources, manufacturers’ failure to submit the exact same dossier to all countries of interest; lack of an integrated information management system; lack of information on national medical regulatory authority or EAC websites; and challenges in monitoring and tracking assessment reports.Conclusion: The use of a robust information technology system for the central tracking of EAC products is essential to address the identified challenges and improve regulatory effectiveness and efficiency. One central point for payment is needed to expedite the process and to ensure transparency and the availability of information on decision making on national and regional websites. Other key strategies for enhancement include improving the capacity of assessors, work and information sharing and a coordination mechanism for the regional joint assessment, with the eventual establishment of a regional medicine agency.

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Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices

Cited by 7 publications

References 25 publications

Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

Impact of the COVID-19 pandemic on the quality of medical products in Zimbabwe: a qualitative study based on key informant interviews with health system stakeholders

Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward

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