Reliance is key to effective access and oversight of medical products in case of public health emergencies

Saint‐Raymond, Agnès; Valentin, Marie; Nakashima, Nobumasa; Orphanos, Nick; Santos, Gustavo Alves Andrade dos; Balkamos, Georgios; Azatyan, Samvel

doi:10.1080/17512433.2022.2088503

Cited by 8 publications

(11 citation statements)

References 1 publication

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“…The current study has indicated that the execution of many regulatory functions during the Covid-19 pandemic was facilitated by the application of knowledge, skills and principles gathered from the training, particularly the concepts of recognition and reliance, as well as horizon scanning. These findings were similar to the recent reports on the presence of big changes in regulatory practices brought about by the Covid-19 pandemic and necessitate detailed training on regulatory preparedness in public health emergencies ( 12 , 13 , 34 , 35 ).…”

Section: Discussionsupporting

confidence: 90%

“…Among other highlighted lessons from the training, an increased understanding of the concept of reliance in regulatory activities is crucial in fighting the wrong notions that matured NRAs are self-sufficient or that relying on others signifies weakness. In that respect, recent findings have shown the growing use of reliance across many regulatory agencies ( 12 , 13 ). Moreover, lessons on having functional regulatory systems encourage the shift in regulators’ focus towards the creation and strengthening of suitable systems for increased regulatory proficiency.…”

Section: Discussionmentioning

confidence: 99%

“…The reported implementation of various learnt aspects by the trainees underscores the role of regulatory training in the strengthening of regulatory systems in the LMICs. In that, the NRAs in the LMICs can potentially attain more robust and thorough regulatory processes towards better access to safe, effective, and good-quality medical products ( 12 , 13 ). Moreover, the shared success stories from the trainees signify the possibility of implementing sustainable changes in the whole regulatory landscape and in turn gaining more confidence and satisfaction from stakeholders, customers, and the public ( 14 , 18 – 20 ).…”

Section: Discussionmentioning

confidence: 99%

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Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Dehaghi,

Khadem Broojerdi,

Paganini

et al. 2023

Front. Med.

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IntroductionTraining opportunities for health product regulators are among the critical aspects in the strengthening of regulatory systems across the world. The need for training is reasonably higher among the National Regulatory Agencies (NRAs) in the Low- and Middle-Income countries (LMICs) which are faced with many regulatory challenges mostly rooted in the low availability of resources. The current study aimed at evaluating the suitability, impacts, and challenges related to the training of regulators from LMICs offered by the Swissmedic in collaboration with the World Health Organization (WHO).MethodologyAn exploratory case study design using a qualitative approach was adopted to collect data from a total of 17 NRAs in different WHO regions using in-depth interviews and qualitative questionnaires.ResultsThe participation of the trainees in the training was revealed to be motivated by the need to apply the obtained knowledge in addressing various challenges within their NRAs. Many lessons covering all key areas of health products regulation were reported by the trainees, whereby most of the lessons were already being implemented within their respective NRAs. However, challenges related to human, financial, and infrastructural resources were highlighted to hinder the ongoing efforts in putting the learned aspects into practice. Additionally, areas in which further regulatory assistance and suggestions for improving the training activities were pointed out.ConclusionThe highlighted gains from the WHO-Swissmedic collaborative training program call for other agencies and organizations to join hands in offering much-needed support towards addressing critical challenges facing the regulatory sector in the LMICs.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Dehaghi,

Khadem Broojerdi,

Paganini

et al. 2023

Front. Med.

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“…To ensure the validity of the questions, the questions were adapted from the GBT. The GBT is the globally accepted standard for benchmarking regulatory authorities (14,15).…”

Section: • Laboratory Testing Andmentioning

confidence: 99%

“…• promote more consistent and robust responses to crises (15). The WHO prequalification programme informs procurement of quality-assured IVDs in RLS.…”

Section: (Which Was Not Certified By Peer Review)mentioning

confidence: 99%

Regulation of Medical Devices in Zimbabwe: A qualitative study with key stakeholders

Chiku,

Maruta,

Mbiba

et al. 2023

Preprint

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Introduction: Medical devices play a crucial role in promoting public health. However, there is a disparity in the availability and readiness of medical device regulations in Resource-Limited Settings (RLS) compared to the global average. We conducted a study to explore the medical device regulation landscape and stakeholder perceptions in Zimbabwe. Methodology: Between June and November 2022, we administered questionnaires to representatives of the Medicines Control Authority of Zimbabwe (MCAZ), the Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCScCZ), and the National Microbiology Reference Laboratory (NMRL). We also conducted semi-structured interviews with 12 national-level critical stakeholders from these institutions to understand the current status of medical device regulations and the relationships between them. Additionally, we interviewed regulators from the South African Health Products Regulatory Authority, Tanzania, and World Health Organisation to learn about best practices in transitioning to medical device regulations. We used a thematic approach and an inductively developed common coding framework to analyse emerging themes. Results: Our findings indicate that the current legal framework needs to be revised to regulate medical devices effectively, as it does not specify the institution(s) responsible for regulating them. While the MCAZ regulates condoms and gloves, the MLCScCZ coordinates with the NMRL to register In Vitro Diagnostic Medical Devices for priority diseases. Other medical devices are not regulated. Furthermore, conformity assessments for product registration are not proportional to the risk classification of medical devices, and post-market surveillance activities are ineffective. Stakeholders recognise the need to collaborate and improve the regulation of medical devices. Conclusion: Zimbabwe must improve its regulatory framework for medical devices to ensure that safe medical devices of acceptable quality and performance are accessible. A solid legal foundation is necessary for harmonisation and reliance practices to reduce the regulatory burden on economic operators and ease the workload on regulators.

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Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group

Chandler,

Balakrishnan,

Brasseur

et al. 2024

BMJ Glob Health

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This analysis describes the successes, challenges and opportunities to improve global vaccine safety surveillance as observed by the Vaccine Safety Working Group from its role as a platform of exchange for stakeholders responsible for monitoring the safety of vaccines distributed through the COVAX mechanism. Three key elements considered to be essential for ongoing and future pandemic preparedness for vaccine developers in their interaction with other members of the vaccine safety ecosystem are (1) the availability of infrastructure and capacity for active vaccine safety surveillance in low-income and middle-income countries (LMICs), including the advancement of concepts of safety surveillance and risk management to vaccine developers and manufacturers from LMICs; (2) more comprehensive mechanisms to ensure timely exchange of vaccine safety data and/or knowledge gaps between public health authorities and vaccine developers and manufacturers; and (3) further implementation of the concept of regulatory reliance in pharmacovigilance. These aims would both conserve valuable resources and allow for more equitable access to vaccine safety information and for benefit/risk decision-making.

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Reliance is key to effective access and oversight of medical products in case of public health emergencies

Cited by 8 publications

References 1 publication

Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Regulation of Medical Devices in Zimbabwe: A qualitative study with key stakeholders

Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group

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