Journal of Pharmaceutical Policy and Practice最新文献

{"title":"A scoping review of the views and experiences of health professionals in the Middle East and North Africa regions regarding social media use.","authors":"Maan Ababneh, Derek Stewart, Scott Cunningham, Sarah Pedersen, Zachariah Nazar","doi":"10.1080/20523211.2026.2647042","DOIUrl":"10.1080/20523211.2026.2647042","url":null,"abstract":"<p><strong>Background: </strong>Integrating social media into healthcare practice presents opportunities and poses key challenges for health professionals. While multiple reviews have been published, Western contexts receive the most attention, despite the distinct cultural and regulatory contexts that may shape social media use in other regions. The aim of this review was to scope the views and experiences of health professionals in the Middle East and North Africa region regarding social media use.</p><p><strong>Methods: </strong>Six databases were systematically searched from inception to November 2022 (updated search in March 2025). Studies published in English reporting the views and experiences of health professionals regarding social media use in 24 MENA countries were included. Two reviewers independently screened articles for selection, followed by data extraction and synthesis.</p><p><strong>Results: </strong>Thirty-eight studies were included; the majority adopted cross-sectional methodology (<i>n</i> = 36), with physicians the most studied group (<i>n</i> = 18) and mostly from Saudi Arabia (<i>n</i> = 22). Only two studies included theory in the development of data collection tools. Positive and negative views and experiences were reported along with the need for education and policies and guidance. Positive themes related to aspects of knowledge and skills, networking, patient communication, marketing, and perceptions of improved practice and enhanced patient care. Negative themes were less well reported and focused on data protection, social media being a distraction, and the perceived impact on well-being.</p><p><strong>Conclusions: </strong>Despite the substantial volume of existing studies, the evidence remains largely descriptive and lacking in theoretical grounding. More rigorous, in-depth research encompassing all health professional groups is needed to clarify the mechanisms through which social media influences practice. Such work is essential for informing robust policies, practical guidelines, and targeted educational strategies that can mitigate risks while maximising the professional and clinical benefits of social media use.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2647042"},"PeriodicalIF":2.6,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13288534/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148317813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating factors associated with pharmaceutical price variation, dispersion and higher-tier pricing in Malaysia's public segmented procurement system: exploring market competition.","authors":"Farahwahida Mohd Kasim, Ernieda Hatah, Lokhman Hakim Osman, Adliah Mhd Ali, Zaheer-Ud-Din Babar","doi":"10.1080/20523211.2026.2677778","DOIUrl":"10.1080/20523211.2026.2677778","url":null,"abstract":"<p><strong>Background: </strong>Effective procurement is crucial for securing affordable medicines, yet limited evidence exists on pricing influences in Malaysia's dynamic pharmaceutical market. This study analysed factors associated with purchased price variation, bidder price dispersion, and higher-tier drug prices within the Ministry of Health's (MOH) segmented procurement system, focusing on market competition dynamics.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on eight high-expenditure therapeutic subgroups (2017-2021) using data from 19 MOH facilities across five regions. Price variation was calculated as the ratio of observed to minimum brand price, and bidder dispersion as the ratio of highest to lowest quoted price. Higher-tier prices exceeded the median price for a given brand. The Kruskal-Wallis H test was applied to examine distributional differences in purchased drug prices and bidder-quoted prices across categorical variables, while logistic regression was used to identify factors associated with higher-tier pricing (<i>p</i> < 0.05). Factors analysed included geographical zones, facility types, procurement values, therapeutic subgroups, purchased product types, dosage forms and the number of competing agents and products.</p><p><strong>Results: </strong>Among 97 drugs from 4,702 purchase records involving 28 suppliers, East Malaysia showed significantly higher price variation, and all regions had greater odds of higher-tier pricing than the Central region (<i>p</i> < 0.05). Lower procurement values were linked to greater price variation and higher-tier pricing (<i>p</i> < 0.05). Imported generics exhibited higher price variation (<i>p</i> < 0.001) but lower prices than innovators and local generics. Procurements with ≥3 competing agents had lower price variation (<i>p</i> < 0.008) but greater bidder dispersion (<i>p</i> < 0.001), while up to five agents increased the likelihood of higher-tier pricing (<i>p</i> < 0.05) compared to 7-12 agents.</p><p><strong>Conclusion: </strong>Findings highlight that both market and non-price competition influence procurement efficiency and price stability.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2677778"},"PeriodicalIF":2.6,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13288543/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148317815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of the 9-item Patient Satisfaction Questionnaire (PSQ-9) for use in community pharmacy settings.","authors":"Fouad Sakr, Mariam Dabbous, Jihan Safwan, Mona El Bakri, Mohamad Rahal, Pascale Salameh","doi":"10.1080/20523211.2026.2686185","DOIUrl":"10.1080/20523211.2026.2686185","url":null,"abstract":"<p><strong>Background: </strong>Patient satisfaction is a key indicator of healthcare quality and a driver of medication adherence and trust in community pharmacy practice. However, validated instruments that specifically assess patients' satisfaction with community pharmacists and pharmacies remain scarce. This study aimed to develop and validate the 9-item Patient Satisfaction Questionnaire (PSQ-9), a concise tool tailored to community pharmacy settings, and to identify factors associated with patient satisfaction.</p><p><strong>Methods: </strong>A cross-sectional online survey of 501 adults from all Lebanese districts was conducted between February and May 2025. The PSQ-9 was derived from the modified 18-item PSQ using exploratory (EFA) and confirmatory (CFA) factor analyses on two independent subsamples. Psychometric testing included internal consistency, test-retest reliability, construct validity, and multigroup CFA to assess measurement invariance. Multivariable linear regression identified correlates of satisfaction.</p><p><strong>Results: </strong>The PSQ-9 demonstrated a two-factor structure, Interpersonal Care and Professional Engagement and Affordability and Informational Assurance, with excellent model fit (CFI = 0.984, RMSEA = 0.056, SRMR = 0.027) and reliability (α = 0.904, ω = 0.910, ICC = 0.729). Measurement invariance was established across gender, health status, and access to care. Higher satisfaction was associated with easier access to healthcare (B = 1.470, <i>P</i> = 0.012), pharmacist counselling from time to time (B = 1.616, <i>P</i> = 0.004) or regularly (B = 1.864, <i>P</i> = 0.008), longer counselling (>10 min; B = 2.441, <i>P</i> = 0.004), higher patient expectations (B = 0.356, <i>P</i> = 0.001) and perceptions (B = 0.110, <i>P</i> = 0.002), and fewer communication barriers (B = -0.235, <i>P</i> = 0.005).</p><p><strong>Conclusion: </strong>The PSQ-9 is a valid, reliable, and contextually adapted instrument for assessing patient satisfaction with community pharmacy services. Its brevity and psychometric robustness make it ideal for large-scale surveys and benchmarking, supporting patient-centered and equitable pharmacy practice improvement.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2686185"},"PeriodicalIF":2.6,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13276807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148295479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methodological quality of health literacy instruments used among school children in Asian countries: a systematic review.","authors":"Nur Aziemah Mohd Fauzi, Mahmathi Karuppannan, Li Shean Toh, Luke Sawyers","doi":"10.1080/20523211.2026.2679556","DOIUrl":"10.1080/20523211.2026.2679556","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to examine the methodological quality of measurement properties of health literacy instruments used in children, specifically in Asian countries, and to identify the most suitable instrument for field application.</p><p><strong>Methods: </strong>This systematic review was conducted following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Health literacy studies conducted between 2013 and 2023 and involving children aged 6-18 years old were identified through searches in PubMed, Scopus and Web of Science. Only studies that assessed methodological qualities were included. Quality appraisal was conducted using COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN).</p><p><strong>Result: </strong>A total of 10 studies met the inclusion criteria from the screening process. The quality of measurement properties in these studies varied. With 9 items on the COSMIN checklist and 10 studies assessed, this resulted in a total of 90 checklist items evaluated. Based on this, 25 items were classified as very good (primarily for structural validity and general criteria), 7 as adequate (mainly for content validity), 14 as inadequate (mostly for internal consistency), 10 as doubtful (mostly for reliability) and 34 as unknown (primarily for measurement error, cross-cultural validity and responsiveness). Nearly 40% (37.7%) of measurement quality ratings were either unknown or not reported. Among the tools assessed, the 8-item Health Literacy Assessment Tool Chinese version (C-HLAT-8) demonstrated very good quality across most measurement properties compared to others. C-HLAT-8 includes functional, interactive and critical health literacy domains and has been assessed in children aged 11-17 in China.</p><p><strong>Conclusion: </strong>Despite the global interest in health literacy, studies focusing on methodological quality in the context of school children and Asian countries remain limited. The C-HLAT 8 emerges as a promising tool for field application due to its strong methodological quality and adaptability.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2679556"},"PeriodicalIF":2.6,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13335402/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148436818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Access to essential medicines for mothers and children: regulatory challenges and gender justice.","authors":"Aga Natalis, Abdul Jalil","doi":"10.1080/20523211.2026.2683095","DOIUrl":"10.1080/20523211.2026.2683095","url":null,"abstract":"","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2683095"},"PeriodicalIF":2.6,"publicationDate":"2026-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13276805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148295487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mixed-methods evaluation of the quantitative and perceived impact of Brexit on UK oncology clinical trial initiation between 2011 and 2020.","authors":"Meena Arora, Sean Elliott, Adrian Kilcoyne, John Bolodeoku, Assem El Baghdady","doi":"10.1080/20523211.2026.2673689","DOIUrl":"10.1080/20523211.2026.2673689","url":null,"abstract":"<p><strong>Introduction: </strong>This study explored the perceived impact of Brexit on oncology clinical trial initiation in the UK, with comparative analysis against Spain and France, and evaluated potential impact on the UK's leadership position in clinical research. A mixed-methods approach was employed comprising: (1) analysis of oncology clinical trial registrations (2011-2020) using ClinicalTrials.gov for the UK, Spain, and France; (2) a stakeholder survey on Brexit-related impacts (<i>n</i> = 22); and (3) a systematic literature review (SLR) conducted in line with PRISMA guidelines using PubMed, Web of Science, Google Scholar, and Embase (2011-2021), with critical appraisal via CASP criteria.</p><p><strong>Discussion and analysis: </strong>Clinical trial volume in the UK declined from 2017, returning to 2011 levels; a trend not mirrored in Spain and only transiently observed in France. From survey results (<i>n</i> = 22), stakeholders acknowledged a negative impact on EU collaboration, highlighting the importance of Horizon Europe programme funding and the role of European Research Networks (ERNs). The SLR identified concerns about increased trial costs, regulatory burden, and reduced patient access to innovative treatments in the UK post-Brexit. Alignment between UK and EU clinical trial regulation was widely seen as essential. UK trial activity shows a marked post-Brexit decline compared to France and Spain. Stakeholder and literature data suggest this trend may affect the UK's access to clinical trials for patients. The negative perception of Brexit's impact on collaboration, funding, and regulatory coherence warrants further investigation and policy response.</p><p><strong>Conclusion: </strong>The decline in UK clinical trial volume to pre-2011 levels poses a risk to patient access and the UK's status as a global leader in drug development. Sustained collaboration with the EU is viewed as vital for mitigating these effects and maintaining research competitiveness.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2673689"},"PeriodicalIF":2.6,"publicationDate":"2026-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13270869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148271989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of China's National Drug Centralized Procurement Policy on pharmaceutical firm innovation: evidence from a staggered difference-in-differences analysis.","authors":"Ying Chen, Wen Feng","doi":"10.1080/20523211.2026.2680235","DOIUrl":"10.1080/20523211.2026.2680235","url":null,"abstract":"<p><strong>Background: </strong>China's National Drug Centralized Procurement Policy (NDCPP) aims to reduce drug prices through a 'price-for-volume' mechanism. While effective in cost containment, its impact on pharmaceutical firms' innovation remains debated, with existing studies often focusing on short-term or static effects.</p><p><strong>Methods: </strong>This study utilises an unbalanced panel of 160 listed Chinese pharmaceutical firms from 2015 to 2023. We employ a multi-period staggered difference-in-differences (DID) model to identify the causal impact of the NDCPP on innovation input (R&D investment intensity) and output (authorised invention patents). Mediation models are constructed to test the roles of cost and operational efficiency.</p><p><strong>Results: </strong>Baseline estimates indicate that the NDCPP significantly increases innovation activities. The implementation of the NDCPP led to an increase in innovation input by 0.0118 units (representing a 1.18 percentage point increase in R&D intensity, or a 22.06% increase relative to the mean) and innovation output by 0.847 units (representing an average annual increase of 0.847 authorised invention patents per firm, or a 14.20% increase relative to the mean). Dynamic analyses reveal an immediate response and continuous enhancement, with promotional effects strengthening from the first to fourth years after policy implementation respectively. Mediation analyses show that cost efficiency significantly mediates innovation output, while strategic inventory management mediates R&D investment. Heterogeneity analyses demonstrate strong responses among private, large, and chemical pharmaceutical firms, with traditional Chinese medicine (TCM) firms also showing significant gains in innovation input.</p><p><strong>Conclusion: </strong>The result indicates a strategic reorientation of pharmaceutical firms, incentivizing a resource reallocation from marketing activities toward substantive R&D activities. The 'price-for-volume' effect offsets price deductions through rapid reorganisation of resources. Future policies should consolidate this momentum and guide enterprises toward high-quality, sustainable innovation.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2680235"},"PeriodicalIF":2.6,"publicationDate":"2026-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148218299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-dose Vitamin D₃ supplementation and glycaemic control in adult males with Type 2 diabetes: a randomised placebo-controlled trial.","authors":"Muhammed Hassan Nasr, Bassam Abdulrasool Hassan, Noordin Othman, Mahmathi Karuppannan, Shalam Mohamed Hussain, Noorizan Binti Abdulaziz, Mohammed Ahmed Alsarani, Ali Haider Mohammed, Siew Li Teoh, Azhar S Al-Zubaidi","doi":"10.1080/20523211.2026.2680824","DOIUrl":"10.1080/20523211.2026.2680824","url":null,"abstract":"<p><strong>Background: </strong>Vitamin D deficiency is common among individuals with type 2 diabetes mellitus (T2DM) and has been linked to insulin resistance and poor glycaemic control. However, findings from randomised controlled trials remain inconsistent.</p><p><strong>Objective: </strong>To evaluate the effect of high-dose vitamin D₃ supplementation on insulin resistance and glycaemic parameters in adult males with T2DM.</p><p><strong>Methods: </strong>This double-blind, randomised, placebo-controlled clinical trial was conducted at Taibah University, Saudi Arabia. Sixty adult males with established T2DM were randomly assigned to receive oral vitamin D₃ (cholecalciferol) 50,000 IU once weekly (n = 30) or a matching placebo (n = 30) for 24 weeks. Fasting blood samples were collected at baseline and post-intervention. The primary outcome was insulin resistance assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes included fasting blood glucose, plasma insulin, glycated haemoglobin (HbA1c), body mass index, lipid profile, and serum 25-hydroxyvitamin D concentrations. Data were analysed using SPSS version 29 (IBM Corp., Armonk, NY, USA).</p><p><strong>Results: </strong>Vitamin D₃ supplementation significantly increased serum 25-hydroxyvitamin D concentrations in the intervention group, with no meaningful change in the placebo group. Despite correction of vitamin D deficiency, there were no statistically significant between-group differences at 24 weeks in insulin resistance, fasting blood glucose, plasma insulin, HbA1c, body mass index, or lipid profile. Within-group changes in metabolic parameters were modest and not statistically significant.</p><p><strong>Conclusion: </strong>In adult males with established T2DM, weekly high-dose vitamin D₃ supplementation for 24 weeks effectively corrected vitamin D deficiency but did not improve insulin resistance or glycaemic control. Vitamin D supplementation should therefore be considered primarily for correcting deficiency rather than for glycaemic management.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2680824"},"PeriodicalIF":2.6,"publicationDate":"2026-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13244506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148211700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From transaction to transformation: a binational perspective on integrating community pharmacy into the digital health ecosystem of Southern European health systems.","authors":"Diamantis Klimentidis, Zaheer Ud-Din Babar, Michael Petrides, Aliki Peletidi","doi":"10.1080/20523211.2026.2677777","DOIUrl":"10.1080/20523211.2026.2677777","url":null,"abstract":"<p><strong>Background: </strong>Community pharmacists (CPs) in the binational Southern European countries of Greece and Cyprus (CG) are among the most accessible healthcare professionals, serving as key points of contact within their health systems; however, despite widespread e-prescription adoption, they remain constrained by limited access to comprehensive patient clinical data. This gap limits their ability to deliver coordinated, evidence-based care and exposes patients to avoidable medication-related harm. Within the evolving framework of the European Health Data Space (EHDS), integrating community pharmacy into national digital infrastructures represents a strategic opportunity for both nations to transition from transactional to transformative practice. This study examines international evidence and policy exemplars to advocate for granting CPs in CG full, role-appropriate, read-and-write access to patients' Electronic Health Records (EHRs), positioning them as integral actors in the digital health ecosystem.</p><p><strong>Methods: </strong>A narrative review of global literature (2021-2025) was undertaken using PubMed, Google Scholar, and institutional sources. Studies and policies were selected for relevance to interoperability, patient safety, and governance. High-impact models, including the UK's read-write EHR pilot, Denmark's Shared Medication Record, and Estonia's national e-health infrastructure, were appraised for transferability to the CG contexts.</p><p><strong>Findings: </strong>International evidence shows that pharmacist participation in interoperable, read-write EHRs enhances medication safety, adherence, and collaboration. Conversely, fragmented or siloed digital infrastructures - such as Greece's limited e-prescription platform or the underutilised national electronic health record system in Cyprus - fall short of enabling genuine clinical integration and coordinated, patient-centred care. A phased roadmap for both countries includes legal recognition of CPs as authorised EHR users, HL7-FHIR-based interoperability, and workforce training in digital competencies. Embedding pharmacoepidemiological indicators in pilots will yield measurable improvements in safety, efficiency, and adherence.</p><p><strong>Conclusion: </strong>For Greece and Cyprus, granting CPs interoperable EHR access is not just digital progress but structural reform, fully integrating pharmacy into Southern Europe's digital health ecosystem.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2677777"},"PeriodicalIF":2.6,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13235219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transitioning regulatory authorities in South Africa: a comparative review of the organisational structure and management practices.","authors":"Anri Hattingh, Jacques Joubert, Michelle Viljoen","doi":"10.1080/20523211.2026.2673693","DOIUrl":"10.1080/20523211.2026.2673693","url":null,"abstract":"<p><strong>Background: </strong>South Africa's transition from the Medicines Control Council (MCC) to the South African Health Products Regulatory Authority (SAHPRA) in 2018 marked a critical shift in the regulatory landscape. The MCC faced prolonged timelines, inadequate resources and a growing application backlog. This review comparatively examines how organisational, governance, managerial and procedural reforms introduced under SAHPRA (2018-2022) addressed these structural and performance limitations, and assesses their implications for regulatory policy and future system strengthening.</p><p><strong>Method: </strong>A mixed-method literature review combining qualitative thematic synthesis and quantitative descriptive analysis was conducted, drawing on publicly available sources, including government reports, academic journal articles, and organisational websites. Quantitative data (e.g. median approval timelines, backlog volumes and approval numbers) were systematically extracted from included studies and official reports without primary statistical modelling. Keywords included 'SAHPRA', 'MCC', 'management structures', 'organisational structures', 'regulatory review process', 'approval timelines', 'medicine approval', and 'regulatory authorities'. Screening followed predefined inclusion and exclusion criteria, and data extraction captured governance structures, funding models, quality systems, reliance pathways, review timelines and backlog metrics.</p><p><strong>Results: </strong>SAHPRA's implementation of reliance-based review pathways and risk-based assessments, alongside streamlined operations, reduced median approval times from 2,124 in 2018 to 783 days in 2020, and increased new chemical entity registrations from 15 to 155 over the same period. The inherited backlog (8,220 new applications in 2018) was cleared by 2022. The transition improved financial independence, enhanced institutional autonomy and reduced administrative bottlenecks. SAHPRA also demonstrated responsiveness during the COVID-19 pandemic through expedited review pathways.</p><p><strong>Conclusion: </strong>The transition from MCC to SAHPRA represents a structural and procedural modernisation of South Africa's regulatory framework. While improving efficiency and access to essential medicines, findings should be interpreted cautiously due to reliance on secondary data and variation across sources. Continued digital reform, capacity development and strengthening post-marketing surveillance remain key priorities.</p>","PeriodicalId":16740,"journal":{"name":"Journal of Pharmaceutical Policy and Practice","volume":"19 1","pages":"2673693"},"PeriodicalIF":2.6,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13235249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}