Frontiers in drug safety and regulation最新文献

{"title":"Editorial: Pandemic preparedness in vaccine safety and regulation.","authors":"Manal M Younus, Florence van Hunsel","doi":"10.3389/fdsfr.2026.1824880","DOIUrl":"10.3389/fdsfr.2026.1824880","url":null,"abstract":"","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1824880"},"PeriodicalIF":0.0,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13121365/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147795920","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":"Physiological actions of \"medical devices made of natural materials\" (such as vegetal matrices) and non-pharmacological actions of \"medical devices made of substances\" (and as such artificial derivatives) as innovations introduced by Regulation 2017/745.","authors":"Marcella Marletta","doi":"10.3389/fdsfr.2026.1807588","DOIUrl":"10.3389/fdsfr.2026.1807588","url":null,"abstract":"<p><p>The European Union's shift from Directive 93/42/EEC to Regulation 2017/745 changes how products made of chemically-defined substances and those made of natural materials should be conceived, evaluated, and regulated. In this study, it is argued that \"medical devices made of substances\" should be distinguished from \"medical devices made of natural materials\" (e.g., vegetal matrices) because the regulatory logic linked to \"substances\" is largely chemistry-centered and may be poorly suited to chemically variable systems whose performance, having the specific medical purpose of restoring a physiological state, emerges from supramolecular, network-level interactions. Regulation 2017/745 provisions addressing devices made of substances require well-defined compositions and identified constituents, consistent with reductionist approaches. In European regulatory practice, \"substance\" is commonly operationalized through well-defined molecular constituents as key players in pharmacological reasoning. In contrast, devices made of \"natural materials\" may modulate interconnected biofunctions and regulatory pathways in ways that cannot be reduced to a single constituent or to the sum of isolated constituents. This \"matrix effect,\" associated with redundancy and functional resilience, shifts quality/performance away from compositional markers and pharmacological, immunological or metabolic means toward a network interaction best framed as a physiological mode of action. Under Regulation 2017/745's \"New Approach,\" manufacturers must justify applicable requirements, classification rules, and validation methods for the specific product. Although devices made of \"substances\" act via non-pharmacological, immunological, or metabolic means, \"substance\"-oriented requirements should not automatically be extended to natural-material devices whose quality and performance arise from whole-matrix properties. Clear differentiation will support proportionate regulation, innovation, and patient benefit.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1807588"},"PeriodicalIF":0.0,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13111906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147795935","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":"Risk of neurodevelopmental disorders after fetal topiramate exposure: a systematic review.","authors":"Renate Eikevåg Lundøy, Anniken Sigvathsen, Marte-Helene Bjørk, Nils Erik Gilhus, Jenny Linnea Victoria Lindroos","doi":"10.3389/fdsfr.2026.1761506","DOIUrl":"10.3389/fdsfr.2026.1761506","url":null,"abstract":"<p><strong>Introduction: </strong>Recent studies suggest an association between fetal topiramate exposure and an increased risk of neurodevelopmental disorders (NDD), such as autism spectrum disorders (ASD), intellectual disability (ID) and attention deficit hyperkinetic disorder (ADHD). This systematic review aimed to evaluate the evidence for such an association.</p><p><strong>Methods: </strong>A systematic literature search was conducted in Medline, Cochrane, and Embase on 16 December 2024, with automatic updates running until submission. Articles were examined if they included any number of offsprings of persons with epilepsy of childbearing potential (PWECP) exposed to topiramate during pregnancy. The main comparison was offspring of pregnant people without epilepsy and no antiseizure medication use, or alternatively antiseizure medication apart from topiramate. The search was limited to English language articles 2014-2024. The study followed PRISMA guidelines for reporting.</p><p><strong>Results: </strong>14 studies were included. The number of topiramate-exposed children ranged from 2 to 1,000. Most studies had a small group exposed to topiramate, and a large control group. Seven studies found a relationship between NDD outcomes and topiramate, three studies found no increased risk, and four studies were inconclusive. However, the risk seems mainly to be increased relative to no ASM use, and in many studies the risk was similar for lamotrigine and seemed lower than for valproate. Methodological approaches varied. Eleven studies were considered to be of good or fair quality, whereas three studies were considered to be of poor quality.</p><p><strong>Conclusion: </strong>This systematic review shows that topiramate prescribing requires caution in PWECP and that topiramate use during pregnancy warrants special attention to the neurodevelopment of the child. The risk seems to be increased relative to no ASM use, is not necessarily higher than the risk for lamotrigine, and lower than the risk of valproate.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1761506"},"PeriodicalIF":0.0,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13066123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680276","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":"Systematic review of AI-based models in pharmacoepidemiology for adverse drug event prediction and detection.","authors":"Apostolia Karampatea, Konstantinos Kassandros, Theodoros Constantinides, Christos Kontogiorgis","doi":"10.3389/fdsfr.2026.1773186","DOIUrl":"10.3389/fdsfr.2026.1773186","url":null,"abstract":"<p><strong>Introduction: </strong>Artificial intelligence (AI) has increasingly been applied in pharmacoepidemiology, yet the methodological landscape of adverse drug event (ADE) prediction remains heterogeneous and insufficiently mapped.</p><p><strong>Methods: </strong>This systematic review aimed to characterize contemporary AI-based approaches used to detect or predict ADEs in real-world clinical data. Following PRISMA 2020 guidelines and a registered protocol (PROSPERO: CRD420251159394), 281 records were screened and 15 studies met the inclusion criteria.</p><p><strong>Results: </strong>All included studies relied primarily on structured electronic health records (EHRs) or administrative claims, while only a minority incorporated natural language processing (NLP) components, and none used spontaneous reporting systems as the primary analytic datasets. Tree-based ensemble models (e.g., Random Forests, XGBoost) and regularized regression were the most commonly adopted algorithms, whereas deep learning architectures appeared less frequently and typically required temporal or representation-based inputs. Through studies, external or temporal validation was rarely performed and explainability methods were inconsistently applied, limiting generalizability. No standardized benchmarks were identified, and reporting practices varied substantially.</p><p><strong>Discussion: </strong>Future work should emphasize rigorous validation, transparent model reporting, and the careful integration of NLP and explainability frameworks to support clinically reliable and scalable pharmacoepidemiological applications.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1773186"},"PeriodicalIF":0.0,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13035781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147597747","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":"Federating AI-related regulations for human therapeutics: an AI-enabled, continuously updating regulatory intelligence system.","authors":"Rominder Singh, Mukesh Pareek, Michael Prokle, Eduardo Sanchez, Uwe Hohgrawe, Jared R Auclair","doi":"10.3389/fdsfr.2026.1718379","DOIUrl":"10.3389/fdsfr.2026.1718379","url":null,"abstract":"<p><p>Global regulation of artificial intelligence (AI) in healthcare remains highly fragmented. Over 1,000 national AI-related regulations and policy frameworks have been introduced across more than 70 countries, most originating from high-income nations. While major drug regulatory authorities, including those in the United States and European Union, and others like WHO, have issued guidance on AI-enabled systems, platforms, and products, no unified source exists that compiles or compares how these bodies govern the broader AI-enabled therapeutic ecosystem. This lack of alignment contributes to disparities in interpretation and implementation, potentially delaying global access to novel AI-based therapies. To address this gap, we developed AI-enabled, continuously updated regulatory intelligence system (AICURIS), a comprehensive AI-enabled regulatory intelligence system trained initially on AI-related regulations from sentinel regulatory authorities (e.g., FDA, EMA, WHO), designed to continuously monitor and classify AI-relevant regulatory content and to enable structured comparison, identification of alignment and divergence, and evidence-informed discussion on regulatory convergence as its coverage expands across jurisdictions. Using over 400,000 regulatory documents published since 2019, an AI-enabled hybrid semantic similarity and keyword scoring model achieved 95% recall for high-confidence AI-related content. The following results summarize the key findings from the analysis of AI-related regulatory documents across three major agencies (United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO)). The findings are presented in six parts: (1) document corpus composition and filtering outcomes, (2) model optimization, (3) classification model performance, (4) classification ensemble model validation, (5) cross-agency bias mitigation, and (6) real-time monitoring capabilities. This study demonstrates that AI-powered, data-driven approaches can effectively federate AI-related drug regulations across jurisdictions, reducing global disparities, and enabling more equitable, collaborative, and efficient human therapeutics innovation.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"6 ","pages":"1718379"},"PeriodicalIF":0.0,"publicationDate":"2026-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13006491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147518347","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":"Hepatobiliary adverse drug reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system.","authors":"Elena-Mirabela Velişcu, Cecilia Cagnotta, Maria Giuseppa Sullo, Antonietta Anatriello, Francesco Salvo, Cristina Scavone","doi":"10.3389/fdsfr.2025.1736759","DOIUrl":"10.3389/fdsfr.2025.1736759","url":null,"abstract":"<p><strong>Background: </strong>olaparib is a Poly ADP-Ribose Polymerase inhibitor approved for the treatment of BRCA-mutated tumors, and has been associated with hepatotoxicity, as highlighted by the Pharmacovigilance Risk Assessment Committee.</p><p><strong>Objectives and methods: </strong>to describe Drug-Induced Liver Injury (DILI) cases related to olaparib stratifying them by liver damage origin in \"cholestatic\", \"cytolytic\", \"mixed\", \"liver related investigation\" and \"not specified\" cases, by analyzing data from EudraVigilance (EV) database.</p><p><strong>Results: </strong>344 Individual Case Safety Reports (ICSRs) reporting olaparib-induced liver injury cases were retrieved from the EV. They referred more frequently to female patients belonging to the age group 18-64 years. The majority of ICSRs (66.0%) reported serious Adverse events (AEs), classified as \"Other Medically Important Condition\", while 23 ICSRs reported fatal AEs. Among the 344 DILI cases, 19.5% were classified as \"cytolytic\", 3.5% as \"cholestatic\" and 1.5% as \"mixed\" origin. Most DILI cases were temporally associated with \"liver-related investigations\" (39.8%) and 15.1% were classified as \"not specified\". A further 20.6% of cases involved PTs related to liver neoplasms (benign or malignant).</p><p><strong>Conclusion: </strong>Further pharmacovigilance studies are needed to evaluate the hepatic safety profile of olaparib. Investigating the pathophysiological mechanisms underlying olaparib-induced liver injury could offer clinicians valuable insights for its prevention and management.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1736759"},"PeriodicalIF":0.0,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12827739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055957","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":"Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women.","authors":"Emeline Maisonneuve, Nicoletta Luxi, Chiara Bellitto, Francesco Ciccimarra, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H Thurin, Francisco Batel-Marques, Kathryn Morton, Fergal O'Shaughnessy, Brian Cleary, Simona Sonderlichová, Andreea Farcas, Camelia Bucsa, Guillaume Favre, Satu J Siiskonen, David Baud, Miriam C J M Sturkenboom, Gianluca Trifirò, Alice Panchaud","doi":"10.3389/fdsfr.2025.1689349","DOIUrl":"10.3389/fdsfr.2025.1689349","url":null,"abstract":"<p><strong>Background: </strong>COVID-19 vaccination is still accepted by only half of pregnant women. Further scientific evidence on the safety of the COVID-19 vaccine could help overcome vaccine hesitancy in this population.</p><p><strong>Objectives: </strong>The aim of this study is to describe and compare the incidence of solicited and unsolicited adverse drug reactions (ADRs) and serious adverse reactions following the booster dose of different COVID-19 vaccines in pregnant women versus the general female population.</p><p><strong>Methods: </strong>We conducted a web-based prospective observational cohort study. In eight European countries, pregnant women and non-pregnant women from the same source population who received a first or second booster dose of COVID-19 vaccine between February 2021 and February 2023 were included in the study if they registered within 48 h after vaccination and completed at least the baseline questionnaire and one follow-up questionnaire. The exposure was a mRNA COVID-19 vaccine of different brands used for a booster dose. The proportion of solicited and unsolicited ADRs following the booster dose by vaccine brand was computed across participating countries in pregnant and non-pregnant women. We performed descriptive analyses of medical characteristics of vaccinees. We compared the proportions of local and systemic solicited ADRs and unsolicited ADRs in pregnant vaccinees with a random sample (1:4 ratio) of age- and vaccine brand-matched vaccinees from the general female population.</p><p><strong>Results: </strong>Overall, 358 pregnant women were matched with 1,432 women from the general population. The proportion of women who reported at least one solicited adverse event was significantly lower in the pregnant group in the non-pregnant group (56.4% [95%CI 51.3%-61.5%] versus 72.3% [95%CI 70.0%-74.6%], p = 0.01). Regarding local ADRs, pregnant women reported significantly less pain and swelling. As for systemic ADRs, pregnant women reported all symptoms less frequently than non-pregnant women, except nausea. The proportion of women who reported at least one unsolicited adverse event was less frequent in the pregnant group (7.8% [95%CI 5.0%-10.6%] versus 24.9% [95%CI 22.7%-27.1%], p = 3.10^-10). Serious adverse events were reported in 0.8% and 0.3% of pregnant and non-pregnant women respectively.</p><p><strong>Conclusion: </strong>This prospective study on COVID-19 vaccine safety monitoring showed that pregnant women from the general population reported solicited and unsolicited ADRs less frequently than non-pregnant women.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1689349"},"PeriodicalIF":0.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12791168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145967951","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 narrative review on the environmental impact of medicines: from water analysis and <i>in vivo</i> studies to prescribing appropriateness, based on European and Italian legal frameworks.","authors":"Irene Cristini, Elisabetta Poluzzi, Federica Soardo, Salvatore Crisafulli, Stefano Polesello, Ursula Kirchmayer, Marco Milani, Francesca Russo, Michele Nicoletti, Giovanna Scroccaro, Paola Deambrosis, Shima Tavakolian Haghighi, Jacopo Grisotto, Ugo Moretti, Giovanna Paolone, Gianluca Trifirò","doi":"10.3389/fdsfr.2025.1681648","DOIUrl":"10.3389/fdsfr.2025.1681648","url":null,"abstract":"<p><p>The environmental impact of medicines has become a growing concern within the One Health framework, which emphasizes the interconnection of human, animal, and environmental health. This narrative review, based on discussions from a 2025 Italian multistakeholder roundtable, explores current strategies for assessing and reducing such impact, including water monitoring, <i>in vivo</i> studies using animal models, prescribing appropriateness, and the relevant European and Italian legal frameworks. The review highlights the crucial role of different stakeholders, including pharmaceutical industries, regulatory agencies, health authorities, researchers, and citizens, in implementing preventive measures to reduce the environmental impact of medicines. It underscores the urgency of integrating environmental sustainability into clinical practice and health policies, encouraging green pharmaceutical innovation, environmentally conscious prescribing, and coordinated governance, in line with the One Health principles. Future research to assess and minimize the environmental footprint of medicines should prioritize the development of standardized metrics for environmental impact, evaluate the long-term efficacy of preventive and mitigation strategies, included those on access to treatments and sustainability of production, and strengthen interdisciplinary collaboration to translate One Health into actionable policies and practices.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1681648"},"PeriodicalIF":0.0,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12756347/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145902245","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":"Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts.","authors":"Camille V Cook","doi":"10.3389/fdsfr.2025.1599217","DOIUrl":"10.3389/fdsfr.2025.1599217","url":null,"abstract":"<p><p>Tokenization is a crucial technology for ensuring the security and privacy of patient data in clinical research, pharmacovigilance, and drug safety monitoring. As healthcare increasingly integrates diverse data sources-ranging from clinical records to non-clinical data such as social determinants of health (SDOH)-it is essential to protect sensitive patient information while improving data quality and analysis (National Institutes of Health, 2006). This article emphasizes tokenization's critical role in safeguarding privacy, particularly in pharmacovigilance activities including safety monitoring, risk assessment, and post-market surveillance. Beyond security, tokenization enriches research datasets by enabling integration of external information, thereby enhancing the rigor and reliability of pharmacovigilance outcomes. With effective tokenization, researchers can better protect patients while gaining deeper insights into clinical and pharmacological research (Cruz et al., 2024). Recent global applications validate tokenization as a foundational privacy-preserving technology in pharmacovigilance. An applied example from a psoriasis clinical trial demonstrated referential tokenization's capacity to securely link electronic health records (EHRs) and claims data across systems with greater than 99% linkage precision while maintaining privacy standards (D'Andrea et al., 2024). These capabilities align with emerging international frameworks, including the European Health Data Space (2025), reinforcing tokenization's value in generating regulatory-grade evidence for pharmacovigilance across national and multinational research environments. In many jurisdictions, tokenization that meets de-identification or pseudonymization standards may not require individual patient consent, though this varies based on data sensitivity, jurisdictional law, and the study's intent (Office for Civil Rights, 2023; EDPB, 2021).</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1599217"},"PeriodicalIF":0.0,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12756134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145902232","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":"Pharmacovigilance and bioethics: the importance of a neglected relationship.","authors":"Giuseppe Alvaro, Michael Müller, Richa Chhibber, Robert Fuentes","doi":"10.3389/fdsfr.2025.1698515","DOIUrl":"10.3389/fdsfr.2025.1698515","url":null,"abstract":"<p><p>This study examines the critical, yet often neglected, link between bioethics and pharmacovigilance-disciplines that collectively aim to ground drug therapies in robust evidence and respect for patient rights. Despite their shared mission, scholarly dialogue between these fields remains sparse. This gap is bridged by tracing their historical foundations and addressing key ethical challenges in pharmacovigilance through the lens of four core bioethical principles: autonomy, beneficence, non-maleficence, and justice. For each principle, pivotal questions and illustrative examples are outlined, offering guidance on embedding ethical reasoning into pharmacovigilance practice. It is argued that while regulations, standard operating procedures, and digital tools are indispensable, they cannot alone resolve the ethical dilemmas posed by rapid scientific innovation, resource constraints, and global inequities, and they may reduce safety professionals to mere task executors. Consequently, it is imperative that alongside technical and regulatory progress, pharmacovigilance fosters the study and application of ethical principles in every aspect of its operation. This transformation will recast it from a purely technical function into an equitable guardian of public health, ensuring sound decision-making, promoting public trust, and delivering maximal benefit while upholding human dignity worldwide.</p>","PeriodicalId":521057,"journal":{"name":"Frontiers in drug safety and regulation","volume":"5 ","pages":"1698515"},"PeriodicalIF":0.0,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12754728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145890838","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}