Frontiers in Medicine | Regulatory Science

Review

Published on 12 Mar 2025

Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia

in Regulatory Science

Yesuneh Tefera Mekasha
Habtamu Getahun
Addisu Afrassa Tegegne
Gemmechu Hasen

Frontiers in Medicine

doi 10.3389/fmed.2025.1452875

4,043 views
2 citations

Review

Published on 05 Mar 2025

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

in Regulatory Science

Francisco D. Rodríguez-Gómez
Dominique Monferrer
Oriol Penon
Pilar Rivera-Gil

Frontiers in Medicine

doi 10.3389/fmed.2025.1544393

10,142 views
76 citations

Perspective

Published on 04 Mar 2025

Valuing patients’ high unmet need to drive innovative therapies for inherited retinal degenerations: insights from the RIWC 2024 workshop on value

in Regulatory Science

Nabin Paudel
Avril Daly

Frontiers in Medicine

doi 10.3389/fmed.2025.1481670

1,595 views

Perspective

Published on 28 Feb 2025

Healthcare AI, explainability, and the human-machine relationship: a (not so) novel practical challenge

in Regulatory Science

Claudia Giorgetti
Giuseppe Contissa
Giuseppe Basile

Frontiers in Medicine

doi 10.3389/fmed.2025.1545409

2,676 views
4 citations

Review

Published on 25 Feb 2025

Data altruism and the “consent” question: a study into the “consent” models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data

in Regulatory Science

Maria Christofidou
Theodoros N. Arvanitis
Dipak Kalra
Nathan Lea
Mahsa Shabani
Pascal Coorevits

Frontiers in Medicine

doi 10.3389/fmed.2024.1489925

3,681 views

Editorial

Published on 21 Feb 2025

Editorial: Ecosystems-centered health and care innovation

in Regulatory Science

Adamantios Koumpis
Panagiotis D. Bamidis
Elisio Costa
Evdokimos Konstantinidis

Frontiers in Medicine

doi 10.3389/fmed.2025.1567993

1,960 views
1 citation

Review

Published on 20 Feb 2025

Defining the value proposition in diagnostic technology: challenges and opportunities for its understanding and development – a review with a multiperspective reflective analysis

in Regulatory Science

Tayana Soukup
Bernarda Zamora-Talaya
Shayan Bahadori
Rosario Luxardo
Patrick Kierkegaard
Omar Butt
Hannah Kettley-Linsell
Katerina-Vanessa Savva
Massimo Micocci
Shanshan Zhou

Frontiers in Medicine

doi 10.3389/fmed.2025.1498618

4,098 views
1 citation

Original Research

Published on 19 Feb 2025

Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance

in Regulatory Science

Renato Ferreira-da-Silva
Mariana Fernandes Lobo
Ana Margarida Pereira
Manuela Morato
Jorge Junqueira Polónia
Inês Ribeiro-Vaz

Frontiers in Medicine

doi 10.3389/fmed.2025.1501921

13,154 views
5 citations

Original Research

Published on 11 Feb 2025

Acceptance of artificial intelligence clinical assistant decision support system to prevent and control venous thromboembolism among healthcare workers: an extend Unified Theory of Acceptance and Use of Technology Model

in Regulatory Science

Jingxian Wang
Yun Zhou
Kai Tan
Zhigang Yu
You Li

Frontiers in Medicine

doi 10.3389/fmed.2025.1475577

3,260 views
1 citation

Original Research

Published on 11 Feb 2025

Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process

in Regulatory Science

Breanne Stewart
Pirkko Lepola
Gunter F. Egger
Fahimeda Ali
Albert J. Allen
Alysha K. Croker
Andrew J. Davidson
Pamela Dicks
Saul N. Faust
Dionna Green

Frontiers in Medicine

doi 10.3389/fmed.2025.1539787

4,519 views
1 citation

Policy and Practice Reviews

Published on 10 Feb 2025

From guideline to practice: three years of ICH S11 insights and recommendations

in Regulatory Science

Diana Tavares
Hsiao-Tzu Chien
Maria Elzbieta Sheean
Peter Theunissen
Peter van Meer
Karen Van Malderen

Frontiers in Medicine

doi 10.3389/fmed.2025.1537001

5,077 views

Systematic Review

Published on 31 Jan 2025

Re-analysis of the current status of clinical trial registration in China

in Regulatory Science

Shuwen Li
Jianhao Li
Wenjing Zeng
Zhicheng Li
Jietong Zhang
Siying Wang
Nenggui Xu
Zeli Li

Frontiers in Medicine

doi 10.3389/fmed.2024.1394803

3,491 views
2 citations

Original Research

Published on 30 Jan 2025

Effects of the Paediatric Regulation funding on the development of off-patent medicines in children

in Regulatory Science

Lucia Ruggieri
Silvia Torretta
Viviana Giannuzzi
Alessandra Natale
Mariagrazia Felisi
Adriana Ceci
Fedele Bonifazi

Frontiers in Medicine

doi 10.3389/fmed.2024.1473862

2,145 views
1 citation

Original Research

Published on 30 Jan 2025

Exploration of policy feedback mechanism for healthcare improvement in China: a grounded theory model

in Regulatory Science

Tuo-Dong Zhu
Ming-Jin Yang
Hao Wu

Frontiers in Medicine

doi 10.3389/fmed.2025.1496836

2,339 views
1 citation

Policy Brief

Published on 27 Jan 2025

Challenges and ongoing initiatives towards better integrated EU scientific advice

in Regulatory Science

Iordanis Gravanis
Michael Berntgen
Spiros Vamvakas
Pierre Demolis
Paolo Foggi

Frontiers in Medicine

doi 10.3389/fmed.2025.1473346

3,579 views
4 citations

Hypothesis and Theory

Published on 24 Jan 2025

A conceptual model and practical guidance for the development, administration, and evaluation of individualized therapies

in Regulatory Science

Lucie Perillat
Andrew McFadyen
Patricia Furlong
James Anderson

Frontiers in Medicine

doi 10.3389/fmed.2025.1493832

2,396 views
1 citation

Perspective

Published on 23 Jan 2025

Navigating the potential and pitfalls of large language models in patient-centered medication guidance and self-decision support

in Regulatory Science

Serhat Aydin
Mert Karabacak
Victoria Vlachos
Konstantinos Margetis

Frontiers in Medicine

doi 10.3389/fmed.2025.1527864

3,959 views
6 citations

Original Research

Published on 15 Jan 2025

Development of digital therapeutics in Hwa-byung treatment: exploring innovation potential in Korean medicine through practitioner survey

in Regulatory Science

Chan-Young Kwon

Frontiers in Medicine

doi 10.3389/fmed.2024.1512337

1,396 views

Original Research

Published on 10 Jan 2025

Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation 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 Épse Kaul Meledje Clamoungou
Oumy Kalsoum Ndao

Frontiers in Medicine

doi 10.3389/fmed.2024.1520892

1,404 views
2 citations

Systematic Review

Published on 08 Jan 2025

Artificial intelligence in healthcare: transforming patient safety with intelligent systems—A systematic review

in Regulatory Science

Francesco De Micco
Gianmarco Di Palma
Davide Ferorelli
Anna De Benedictis
Luca Tomassini
Vittoradolfo Tambone
Mariano Cingolani
Roberto Scendoni

Frontiers in Medicine

doi 10.3389/fmed.2024.1522554

23,544 views
17 citations

Original Research

Published on 07 Jan 2025

Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation

in Regulatory Science

Io Wens
Zilke Claessens
Alice Vanneste
Liese Barbier
Rosanne Janssens
Isabelle Huys

Frontiers in Medicine

doi 10.3389/fmed.2024.1506243

3,854 views

Perspective

Published on 07 Jan 2025

Gaps in the ethical governance of pharmaceutical clinical trials in Europe

in Regulatory Science

Rosemarie D. L. C. Bernabe
Shereen A. Dawkins-Cox
Christine C. Gispen-de Wied

Frontiers in Medicine

doi 10.3389/fmed.2024.1507021

2,560 views
1 citation

Opinion

Published on 19 Dec 2024

Bridging the gap in AI integration: enhancing clinician education and establishing pharmaceutical-level regulation for ethical healthcare

in Regulatory Science

Alessandro Perrella
Francesca F. Bernardi
Massimo Bisogno
Ugo Trama

Frontiers in Medicine

doi 10.3389/fmed.2024.1514741

3,016 views
4 citations

Opinion

Published on 18 Dec 2024

Personalized medicine: when the common becomes the rare

in Regulatory Science

Daniel J. O'Connor

Frontiers in Medicine

doi 10.3389/fmed.2024.1523594

2,986 views

504 articles

articles

Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

Valuing patients’ high unmet need to drive innovative therapies for inherited retinal degenerations: insights from the RIWC 2024 workshop on value

Healthcare AI, explainability, and the human-machine relationship: a (not so) novel practical challenge

Data altruism and the “consent” question: a study into the “consent” models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data

Editorial: Ecosystems-centered health and care innovation

Defining the value proposition in diagnostic technology: challenges and opportunities for its understanding and development – a review with a multiperspective reflective analysis

Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance

Acceptance of artificial intelligence clinical assistant decision support system to prevent and control venous thromboembolism among healthcare workers: an extend Unified Theory of Acceptance and Use of Technology Model

Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process

From guideline to practice: three years of ICH S11 insights and recommendations

Re-analysis of the current status of clinical trial registration in China

Effects of the Paediatric Regulation funding on the development of off-patent medicines in children

Exploration of policy feedback mechanism for healthcare improvement in China: a grounded theory model

Challenges and ongoing initiatives towards better integrated EU scientific advice

A conceptual model and practical guidance for the development, administration, and evaluation of individualized therapies

Navigating the potential and pitfalls of large language models in patient-centered medication guidance and self-decision support

Development of digital therapeutics in Hwa-byung treatment: exploring innovation potential in Korean medicine through practitioner survey

Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement

Artificial intelligence in healthcare: transforming patient safety with intelligent systems—A systematic review

Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation

Gaps in the ethical governance of pharmaceutical clinical trials in Europe

Bridging the gap in AI integration: enhancing clinician education and establishing pharmaceutical-level regulation for ethical healthcare

Personalized medicine: when the common becomes the rare