Frontiers in Medicine | Regulatory Science

Original Research

Published on 26 Sep 2025

Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US

in Regulatory Science

Giorgio Reggiardo
Alessandra Natale
Nicola Santoro
Viviana Giannuzzi
Claudia Pansieri
Mariagrazia Felisi
Donato Bonifazi
Adriana Ceci

Frontiers in Medicine

doi 10.3389/fmed.2025.1642279

2,067 views

Original Research

Published on 23 Sep 2025

Harmonizing health: a global analysis of pharmaceutical regulatory activities by international regulatory organizations

in Regulatory Science

Agnes Dangy-Caye
Alice Mousset
Adem Kermad
Louise Bouché-Bazerolle
Magda Bujar
Maria-Lucia De Lucia
Neil McAuslane
Rebecca Lumsden

Frontiers in Medicine

doi 10.3389/fmed.2025.1636269

9,659 views
1 citation

Original Research

Published on 22 Sep 2025

Barriers and determinants of over-the-counter antibiotic sales de-escalation: perspectives of community pharmacists in Aseer, Saudi Arabia

in Regulatory Science

Sultan M. Alshahrani
Sirajudeen Shaik Alavudeen

Frontiers in Medicine

doi 10.3389/fmed.2025.1677246

2,375 views
1 citation

Original Research

Published on 17 Sep 2025

Performance analysis of EAC joint GMP inspections (2016–2022): a pathway to strengthening regulatory systems and building capacity in Africa’s less resourced authorities

in Regulatory Science

Jane Mashingia
Noel Aineplan
Kari Clase
Steven Bryn
Zita Ekeocha

Frontiers in Medicine

doi 10.3389/fmed.2025.1644446

1,880 views

Review

Published on 15 Sep 2025

Transforming the interrelated nature of human psychoneuroendocrine health and endocrine disrupting compounds in our planet’s water: from Wilhelm Waldeyer’s neuron theory to an artificial intelligence extension of the human body?

in Regulatory Science

Sophie Schweizer-Schubert
Götz von Waldeyer-Hartz
Susann-Elisabeth Schütze
Daniel Mahringer
Aki Sebastian Ruhl
Markus Graf
Jochen Kuckelkorn

Frontiers in Medicine

doi 10.3389/fmed.2025.1583203

2,127 views

Original Research

Published on 11 Sep 2025

Preparing for the European Health Data Space: an open-source compiler for fast, transparent, and portable health data transformations

in Regulatory Science

Stefan Beyer
Nikola Tanjga
Gabriel Kleinoscheg
Dieter Hayn
Klaus Donsa
Karl Kreiner
Günter Schreier

Frontiers in Medicine

doi 10.3389/fmed.2025.1661091

2,050 views
1 citation

Systematic Review

Published on 11 Sep 2025

Visual analysis of quality management in Chinese drug clinical trials based on CiteSpace and COOC

in Regulatory Science

Jiayan Xia
Xuemei Ning
Lamei Jiang
Peipei Li
Jie Huang
Wenxiu Jiang
Wen Li
Cheng Wang
Linsha Zheng
Ting Jiang

Frontiers in Medicine

doi 10.3389/fmed.2025.1600915

2,293 views
1 citation

Systematic Review

Published on 10 Sep 2025

Societal participation in the development of orphan drugs: a systematic review

in Regulatory Science

Sanae Akodad
Delphine De Smedt
Hilde Stevens

Frontiers in Medicine

doi 10.3389/fmed.2025.1653304

2,359 views
1 citation

Policy Brief

Published on 09 Sep 2025

Accelerating European electronic health record exchange format (EEHRxF) implementation across Europe: a policy perspective

in Regulatory Science

Nathan da Silva Carvalho
Alexia Papadimitriou
Robert Stegwee
Hans Gille
Michael Strübin
Christophe Maes
Giorgio Cangioli
Catherine Chronaki

Frontiers in Medicine

doi 10.3389/fmed.2025.1648170

2,600 views

Correction

Published on 05 Sep 2025

Correction: Summary of the best evidence for the use of antiseptics at various surgical sites to prevent postoperative infections

in Regulatory Science

Frontiers Production Office

Frontiers in Medicine

doi 10.3389/fmed.2025.1698325

1,048 views

Original Research

Published on 04 Sep 2025

Lessons from Ethiopian pharmaceutical regulation: a risk-based approach to overcome challenges and unlock opportunities

in Regulatory Science

Hassen Kebede Hassen
Yesuneh Tefera Mekasha
Addisu Afrassa Tegegne
Yildiz Ozalp

Frontiers in Medicine

doi 10.3389/fmed.2025.1484649

4,407 views

Perspective

Published on 02 Sep 2025

How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology

in Regulatory Science

Emanuel Krebs
Deirdre Weymann
Tania Bubela
Dean A. Regier

Frontiers in Medicine

doi 10.3389/fmed.2025.1563950

2,542 views

Editorial

Published on 29 Aug 2025

Editorial: Errors and biases in modern healthcare: public health, medico-legal and risk management aspects

in Regulatory Science

Simone Grassi
Francesco Ausania
Davide Ferorelli
Francesco De Micco

Frontiers in Medicine

doi 10.3389/fmed.2025.1676522

1,384 views

Original Research

Published on 29 Aug 2025

Possibilities for secondary data use of electronic health records with WiseSpace de-identification

in Regulatory Science

Olga Vovk
Ali Ghasempour
Gunnar Piho
Peeter Ross

Frontiers in Medicine

doi 10.3389/fmed.2025.1639342

1,825 views

Perspective

Published on 26 Aug 2025

Who moved my scan? Early adopter experiences with pre- and post-market healthcare AI regulation challenges

in Regulatory Science

Aviad Raz
Yael Inbar
Netta Avnoon
Liat Bela Lifshitz-Milwidsky
Barkan Hofman
Asaf Honig
Ziv Paz

Frontiers in Medicine

doi 10.3389/fmed.2025.1651934

1,737 views
1 citation

Review

Published on 14 Aug 2025

Symptoms and adverse events in controlled human infection models

in Regulatory Science

Karen Götz
Poleta Luga
Jörg Rengel
Mei Masur
Marcela Juárez-Hernández
Isabelle Bekeredjian-Ding

Frontiers in Medicine

doi 10.3389/fmed.2025.1578560

2,461 views

Original Research

Published on 13 Aug 2025

Automatic extraction of SmPC document for IDMP data model construction using foundation LLM and RAG: a preliminary experiment for pharmaceutical regulatory affairs

in Regulatory Science

Hocine Kadi
Alaa Abdellatif
Daniel Isaac Kemajou Njamen
Florian Pereme

Frontiers in Medicine

doi 10.3389/fmed.2025.1598979

3,320 views

Editorial

Published on 12 Aug 2025

Editorial: Regulatory science and meta science as components of regulation of medical products and practices

in Regulatory Science

Barbara K. Redman
Christine Gispen-de Wied
Thalia Arawi

Frontiers in Medicine

doi 10.3389/fmed.2025.1664402

1,528 views

Case Report

Published on 11 Aug 2025

Birth-related long bone fractures in otherwise healthy newborns and medical professional liability: literature review and case presentation

in Regulatory Science

M. Trabucco Aurilio
L. Fava
M. Chisari
M. Bolcato

Frontiers in Medicine

doi 10.3389/fmed.2025.1589417

2,093 views

Systematic Review

Published on 08 Aug 2025

Summary of the best evidence for the use of antiseptics at various surgical sites to prevent postoperative infections

in Regulatory Science

Qingqing Du
Shan Wu
Ziwei Jin
Li Ni

Frontiers in Medicine

doi 10.3389/fmed.2025.1630272

5,295 views
1 citation

Methods

Published on 05 Aug 2025

Implementation of a quality management system for decentralized manufacturing of cell and gene therapy products - technical and regulatory considerations

in Regulatory Science

Heiko von der Leyen
Julio Delgado
Chaya Mazouz
Michael Schmitt
Vered Caplan

Frontiers in Medicine

doi 10.3389/fmed.2025.1591751

3,428 views
1 citation

Original Research

Published on 30 Jul 2025

A roadmap for personalized medicine: the findings of the IC2PerMed project

in Regulatory Science

Flavia Beccia
Francesco Andrea Causio
Marzia Di Marcantonio
Ilda Hoxhaj
Chiara Cadeddu
Melissa Campagno
Lena Schleicher
Carmen Fotino
Maike Tauchert
Marta Lomazzi

Frontiers in Medicine

doi 10.3389/fmed.2025.1572921

3,102 views

Brief Research Report

Published on 24 Jul 2025

The route to financial sustainability of a large Public Private Partnership—the example of the clinical trial network conect4children (c4c)

in Regulatory Science

Laetitia Paumard
Heidrun Hildebrand
Marianne Engel
Pirkko Lepola
Esther Montero
Frank Tennigkeit
Magda Rosenmöller

Frontiers in Medicine

doi 10.3389/fmed.2025.1599997

2,202 views

Review

Published on 17 Jul 2025

A decade of review in global regulation and research of artificial intelligence medical devices (2015–2025)

in Regulatory Science

Siwen Zhang
Yujun Li
Wenxi Liu
Qi Chu
Shasha Wang
Jinyu Li
Yuwen Chen

Frontiers in Medicine

doi 10.3389/fmed.2025.1630408

9,793 views
6 citations

517 articles

articles

Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US

Harmonizing health: a global analysis of pharmaceutical regulatory activities by international regulatory organizations

Barriers and determinants of over-the-counter antibiotic sales de-escalation: perspectives of community pharmacists in Aseer, Saudi Arabia

Performance analysis of EAC joint GMP inspections (2016–2022): a pathway to strengthening regulatory systems and building capacity in Africa’s less resourced authorities

Transforming the interrelated nature of human psychoneuroendocrine health and endocrine disrupting compounds in our planet’s water: from Wilhelm Waldeyer’s neuron theory to an artificial intelligence extension of the human body?

Preparing for the European Health Data Space: an open-source compiler for fast, transparent, and portable health data transformations

Visual analysis of quality management in Chinese drug clinical trials based on CiteSpace and COOC

Societal participation in the development of orphan drugs: a systematic review

Accelerating European electronic health record exchange format (EEHRxF) implementation across Europe: a policy perspective

Correction: Summary of the best evidence for the use of antiseptics at various surgical sites to prevent postoperative infections

Lessons from Ethiopian pharmaceutical regulation: a risk-based approach to overcome challenges and unlock opportunities

How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology

Editorial: Errors and biases in modern healthcare: public health, medico-legal and risk management aspects

Possibilities for secondary data use of electronic health records with WiseSpace de-identification

Who moved my scan? Early adopter experiences with pre- and post-market healthcare AI regulation challenges

Symptoms and adverse events in controlled human infection models

Automatic extraction of SmPC document for IDMP data model construction using foundation LLM and RAG: a preliminary experiment for pharmaceutical regulatory affairs

Editorial: Regulatory science and meta science as components of regulation of medical products and practices

Birth-related long bone fractures in otherwise healthy newborns and medical professional liability: literature review and case presentation

Summary of the best evidence for the use of antiseptics at various surgical sites to prevent postoperative infections

Implementation of a quality management system for decentralized manufacturing of cell and gene therapy products - technical and regulatory considerations

A roadmap for personalized medicine: the findings of the IC2PerMed project

The route to financial sustainability of a large Public Private Partnership—the example of the clinical trial network conect4children (c4c)

A decade of review in global regulation and research of artificial intelligence medical devices (2015–2025)