ArticleInternational journal of health policy and management2022
A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency.
Article in International journal of health policy and management, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Benchmarking Drug Regulatory Systems for Capacity Building: An Integrative Review of Tools, Practice, and Recommendations.International journal of health policy and management · 2023Pooled it
- Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference.Clinical pharmacology and therapeutics · 2026Article
- Transitioning regulatory authorities in South Africa: a comparative review of the organisational structure and management practices.Journal of pharmaceutical policy and practice · 2026Review
- Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities.Therapeutic innovation & regulatory science · 2025Article
- Assessment of compliance with good review practices by medicine assessors within the Zambia medicines regulatory authority.Frontiers in medicine · 2025Article
- The Implementation of a Risk-Based Assessment Approach by the South African Health Products Regulatory Authority (SAHPRA).Pharmaceutical medicine · 2023Article
- Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.Frontiers in medical technology · 2022Review
- South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access.Frontiers in pharmacology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNational regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new regulatory review model for improved regulatory performance, underpinned by the parameters of the World Health Organization Global Benchmarking Tool (WHO GBT) that support strengthening of regulatory systems.
methodsA new enhanced model for regulatory review, was developed based on the key recommendations from 6 studies, previously conducted by the authors, that were identified as fundamental elements in enhancing regulatory performance. The elements selected to define the new regulatory review model were endorsed through the integration of the parameters of the WHO GBT that, when embedded within regulatory systems, support enhanced regulatory performance.
resultsOpportunities for improvement in regulatory performance were identified and include quality measures; monitoring and evaluating review times; a risk-based evaluation; transparency and communication; and training and education. An improved model for the South African regulatory review and benefit-risk (BR) assessment supported by quality decision-making was proposed as well as recommendations for the application of risk-stratification strategies, strengthening of reliance networks, reinforcing good regulatory practices (GRPs) and enhancing transparency.
conclusionIf implemented the proposed improved regulatory model may pave the way towards more efficient and transparent, streamlined review processes, coupled with increased consistency, evidence-based decision-making practices, reduced timelines and improved patients' access to new medicines in South Africa.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.