A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency

Keyter, Andrea; Salek, Sam; Banoo, Shabir; Walker, Stuart

doi:10.34172/ijhpm.2020.213

Cited by 4 publications

(14 citation statements)

References 9 publications

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“…For example, in 2010, SAHPRA received 1204 applications and could only register 425, resulting in 779 backlog applications. The collective backlog by May 2016 was 7902 applications and only 3779 were registered between 2006 and 2015 [ 27 ]. There were 3505 in-process applications in the initial phase for identification of their status and 4397 applications not yet allocated for review in the second phase [ 27 ].…”

Section: Resultsmentioning

confidence: 99%

“…The collective backlog by May 2016 was 7902 applications and only 3779 were registered between 2006 and 2015 [ 27 ]. There were 3505 in-process applications in the initial phase for identification of their status and 4397 applications not yet allocated for review in the second phase [ 27 ]. The results from these two phases were investigated and the outcomes are detailed below.…”

Section: Resultsmentioning

confidence: 99%

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The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA)

Moeti

Litedu²,

Joubert

2023

Pharm Med

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Background An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South African Health Products Regulatory Authority (SAHPRA) inherited from the Medicine Control Council (MCC). Revising and implementing new regulatory pathways is one of the strategic mechanisms that SAHPRA employs to circumvent this problem. Objectives To alleviate the backlog, the use of a new review pathway termed the risk-based review on the scientific quality and bioequivalence assessments was explored. The objective of the study was to articulate the risk-based assessment (RBA) pathway, to determine robust criteria for the classification of the levels of risk for medicines, and to define the improved process to be followed in the assessment and approval of medicines. Methods In 2015, an extensive exercise was conducted by SAHPRA to identify the unknown status of in-process applications. The RBA pilot project commenced in 2016 and further piloted in 2021 using the knowledge gained from the 2016 study for optimisation of efficiency. Results By 2015 the backlog was quantified as 7902 applications in the pre-registration phase. The 2015 project entailed two phases. The initial phase was conducted to identify the status of 3505 in-process applications, which resulted in the registration of 198 applications. The second phase commenced in 2016 on 4397 applications not yet reviewed whereby the RBA approach was explored. With the developed criteria for risk classification and refined end-to-end registration process, the pilot resulted in a finalisation time with a median value of 90 calendar days and a median approval time of 109 calendar days. The throughput of the RBA pilot study conducted in 2021 was 68 calendar days finalisation time for the 63 applications used. These finalisation times are lower in comparison to the 501 calendar days for the current process employed by SAHPRA for the backlog clearance programme initiated in 2019. Both the 2016 and 2021 studies had similar approval times calculated from the date of allocation of scientific assessments. The reported evaluation timelines for both studies were within 6–7 h for a low-risk quality assessment, 9–10 h for a high-risk quality assessment, 7–8 h for a bioequivalence assessment, and 2–3 h for a biowaiver and initial response assessment. Conclusions The refined processes used in the risk-based pilot studies to alleviate the SAHPRA backlog are described in detail. The process managed a reduction of the finalisation time to 68 calendar days in comparison to 501 calendar days for the current process that was employed by SAHPRA for the backlog clearance programme initiated in 2019. The RBA approach, therefore, reduces the finalisation and approval times for quality and bioequivalence assessments for regulatory authorities without compromising on the quality, safety and efficacy of the medicinal products. In addition...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA)

Moeti

Litedu²,

Joubert

2023

Pharm Med

View full text Add to dashboard Cite

show abstract

“… 11 - 15 , 18 - 20 , 26 - 60 The research design included literature review (n = 3), 28 , 32 , 49 expert interview (n = 1), 48 empirical analysis (n = 2), 43 , 52 comparative analysis (n = 7), 12 , 15 , 35 , 42 , 47 , 58 , 59 retrospective analysis (n = 2), 19 , 41 questionnaire (n = 10), 14 , 20 , 26 , 27 , 37 - 40 , 55 , 56 description analysis (n = 6), 11 , 13 , 33 , 36 , 45 , 60 and mixed methods (n = 12). 18 , 29 - 31 , 34 , 44 , 46 , 50 , 51 , 53 , 54 , 57…”

Section: Resultsmentioning

confidence: 99%

Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice and Recommendations

Shi,

Chen,

et al. 2023

Int J Health Policy Manag

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Background: Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening. This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon. Method: This study employed an integrative and critical review of the literature and documents on benchmarking drug regulatory capacities identified from 6 databases and 5 websites of related organizations and government agencies in compliance with the Preferred Reporting Items for Systematic Review (PRISMA) guidelines. Results: Forty-three studies and 6 documents about regulatory benchmarking published between 2005 and 2022 were included in this review. Five benchmarking assessment tools or programmes recommended or adopted by international organizations or government agencies had been identified, which collectively covered 12 major regulatory functions (4 at system level and 8 at operational level) involving 9 indicator categories and 382 sub-indicators. Benchmarking drug regulatory systems was reportedly employed at national, regional and international levels for either internal assessment (mostly on regulatory system establishment, drug review process and post marketing surveillance) or external evaluation (mostly on regulatory standards, drug review process and pharmacovigilance systems) to assess current status, monitor performance, determine major challenges and inform actions for capacity building. Priority of actions in areas such as regulatory process, resources allocation, cooperation and communication, and stakeholder engagement have been suggested for strengthening drug regulatory systems. Nevertheless, the evidence about benchmarking in optimizing regulatory capacities remained underreported. Conclusion: This integrative review depicted a framework for decision-makers about why and how benchmarking drug regulatory systems should be undertaken. For effective benchmarking, well-informed decisions about the goals, the scope, the choice of reference points and benchmarking tools are essential to guide the implementation strategies. Further studies about the positive effects of regulatory benchmarking are warranted to engage continuous commitment to the practice.

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“…Currently, most African governments have developed regulatory bodies, such as the Uganda National Drugs Authority in Uganda ( 47 ) and South African Health Products Authority ( 48 ) in South Africa, to ensure the protection and efficiency of new medical devices. Such bodies are required to act in a well-organized and appropriate style so as to save and benefit patients.…”

Section: Challenges Affected By Medical Devices Clinical Trials In Af...mentioning

confidence: 99%

Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations

Matovu

Takuwa

Mpaata

et al. 2022

Front. Med. Technol.

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Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.

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A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency

Cited by 4 publications

References 9 publications

The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA)

The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA)

Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice and Recommendations

Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations

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