Frontiers in Medicine | Regulatory Science

Methods

Accepted on 04 Jul 2025

Implementation of a Quality Management System for decentralized manufacturing of cell and gene therapy products -technical and regulatory considerations_ von der Leyen et al. -1 -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

Original Research

Published on 04 Jul 2025

Towards a clinical pathway to food for special medical purpose in China: current progress based on a cross-sectional survey

in Regulatory Science

Jie Gong
Mengyan Wang
Jiankui Guo
Yishu Lyu
Dongyu Mu
Lei Shi
Wen Hu
Fengmei Yu

Frontiers in Medicine

doi 10.3389/fmed.2025.1538105

145 views

Systematic Review

Published on 01 Jul 2025

Global trends of big data analytics in health research: a bibliometric study

in Regulatory Science

Li Yao
Yan Liu
Tingrui Wang
Chunyan Han
Qiaoxing Li
Qinqin Li
Xiaoli You
Tingting Ren
Yinhua Wang

Frontiers in Medicine

doi 10.3389/fmed.2025.1456286

719 views

Editorial

Accepted on 30 Jun 2025

Research Topic: The Changing Focus of Regulatory Frameworks Around the Globe and the Opportunities for Harmonization -Editorial

in Regulatory Science

Armando Magrelli
Daniel O'Connor
Violeta Stoyanova-Beninska

Frontiers in Medicine

doi 10.3389/fmed.2025.1645278

155 views

Review

Accepted on 27 Jun 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
Yuwen Chen

Frontiers in Medicine

doi 10.3389/fmed.2025.1630408

264 views

Perspective

Accepted on 27 Jun 2025

Beyond Human Limits: The Ethical, Social, and Regulatory Implications of Human Enhancement

in Regulatory Science

Chiara Gerardi
Christodoulos Xinaris

Frontiers in Medicine

doi 10.3389/fmed.2025.1595213

103 views

Original Research

Published on 26 Jun 2025

Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency

in Regulatory Science

Simonita Alaburde
Justinas Ivaska
Greta Kaspute
Tatjana Ivaskiene

Frontiers in Medicine

doi 10.3389/fmed.2025.1623689

442 views

Original Research

Published on 18 Jun 2025

Using ChatGPT to assist in judging the indications for emergency ultrasound: an innovative exploration of optimizing medical resource allocation

in Regulatory Science

Zhirong Xu
Jiayi Ye
Jiemin Chen
Xiaoqian Zhang
Jiawei Wang

Frontiers in Medicine

doi 10.3389/fmed.2025.1567608

480 views

Original Research

Published on 16 Jun 2025

Promoting the development and approval of new traditional Chinese medicines in China: a pooled analysis of data from 2013 to 2024

in Regulatory Science

Xiaohong Long
Jie Zhang
Li Yang

Frontiers in Medicine

doi 10.3389/fmed.2025.1559703

574 views

Original Research

Accepted on 11 Jun 2025

Comparison of the review models and regulatory timelines of seven countries participating in the ECOWAS-MRH initiative: Identifying opportunities for improvement

in Regulatory Science

Mercy Owusu-Asante
Delese Mimi Darko
Seth Seaneke
Aminata Nacoulma
Oula Ibrahim Olivier Traore
Christianah Mojisola Adeyeye
Abayomi Akinyemi
Coulibaly Assane
Clarisse Epse Kaul Meledje Clamoungou
Oumy Kalsoum Ndao

Frontiers in Medicine

doi 10.3389/fmed.2025.1587761

168 views

Original Research

Published on 11 Jun 2025

From data to medical context: the power of categorization in healthcare

in Regulatory Science

Batoul Msheik
Hamid Mcheick
Sara Hariri
Mehdi Adda
Mohamed Dbouk

Frontiers in Medicine

doi 10.3389/fmed.2025.1575195

844 views

Brief Research Report

Accepted on 10 Jun 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
Marianne Engel
Pirkko Lepola
Esther Montero
Frank Tennigkeit
Heidrun Hildebrand
Magda Rosenmoller

Frontiers in Medicine

doi 10.3389/fmed.2025.1599997

190 views

Methods

Published on 09 Jun 2025

Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network

in Regulatory Science

Sabah Attar
Francisca P. Figueiras
Carla Peacock
Hazel Wohlfahrt
Birgitta C. P. Hüsken
Susan Andrews
Pirkko Lepola
Margaret Patton
Regis Hankard
Eren Halil

Frontiers in Medicine

doi 10.3389/fmed.2025.1531276

1,029 views

Policy and Practice Reviews

Accepted on 06 Jun 2025

New medicines for childhood-onset Systemic Lupus Erythematosus: an EU perspective on paediatric drug development

in Regulatory Science

Roberto De Lisa
Fernando de Andres Trelles
Ralph Bax
Sara Galluzzo
Brian Aylward
Andrew Thomson
Dominik Karres
Hermine Brunner
Nicolino Ruperto
Gunter Egger

Frontiers in Medicine

doi 10.3389/fmed.2025.1583140

275 views

Review

Published on 04 Jun 2025

Training and practice for drug inspectors in China: experiences, challenges, and developments

in Regulatory Science

Jinyao Sun
Lubo Guo
Zhixiang Shi
Fang Wu
Yongze Zhang

Frontiers in Medicine

doi 10.3389/fmed.2025.1571922

1,117 views

Original Research

Accepted on 03 Jun 2025

To treat or not to treat? Oncologists' perceptions and experiences regarding overtreatment in end stage cancer patients

in Regulatory Science

Saritte Perlman
Aviad Raz
Pesach Shvartzman
Raphael Catane
Tamar Freud
Moriah E Ellen

Frontiers in Medicine

doi 10.3389/fmed.2025.1607479

261 views