Frontiers in Medicine | Regulatory Science

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

326 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

326 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

647 views

Original Research

Accepted on 03 Sep 2025

Considerations on the implementation of DCT: A SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan

in Regulatory Science

Hiroyuki Taruno
Koji Ikeda
Marika Oikawa
Takahiro Sato
Yuka Suzuki
Mayumi Shikano

Frontiers in Medicine

doi 10.3389/fmed.2025.1521135

346 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

762 views

Original Research

Accepted on 01 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

298 views

Systematic Review

Accepted on 01 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

408 views

Systematic Review

Accepted on 29 Aug 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

191 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

654 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

667 views

Original Research

Accepted on 28 Aug 2025

Harmonizing Health: A Global Analysis of Pharmaceutical Regulatory activities by international regulatory organizations

in Regulatory Science

Agnès Dangy-Caye
Alice Mousset
Adem Kermad
Louise BOUCHE BAZEROLLE
Magda Bujar
Maria De Lucia
Neal McAuslane
Rebecca Lumsden

Frontiers in Medicine

doi 10.3389/fmed.2025.1636269

359 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

836 views

Perspective

Accepted on 20 Aug 2025

The regulatory and scientific context in the study of the Medicinal use of Cannabis in Peru

in Regulatory Science

Pedro Wong-Salgado
Jeel Moya-Salazar
Hans Contreras-Pulache
Claudio Pardo- Villarroel

Frontiers in Medicine

doi 10.3389/fmed.2025.1598227

271 views

Original Research

Accepted on 15 Aug 2025

Analysis of Timelines for EAC Joint GMP Inspections, 2016-2022: A Pathway for Regulatory System Strengthening in Africa and Capacity Building of Less Resourced National Regulatory Authorities (NRAs)

in Regulatory Science

Jane Humphrey Mashingia
Noel Aineplan
Kari L Clase
Steven Bryn
Zita Ekeocha

Frontiers in Medicine

doi 10.3389/fmed.2025.1644446

234 views

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

1,378 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

1,703 views