Frontiers in Drug Safety and Regulation | Pharmaceutical Policy and Regulation

Original Research

Published on 10 Jun 2026

Methodological comparisons for benefit-risk assessment in complex decision-making: applications and insights from a case study

in Pharmaceutical Policy and Regulation

Jian-Yu E
Kexin Zhu
Stéphanie Tcherny-Lessenot
Juhaeri Juhaeri

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2026.1792441

1,304 views

Community Case Study

Published on 29 May 2026

Strengthening pharmacovigilance and regulatory capacity in Southern Africa (SPaRCS): achievements, experiences and lessons learned from a participatory action learning project

in Pharmaceutical Policy and Regulation

Michelle Viljoen
Star Khoza
Mukesh Dheda
Libert Chirinda
Frieda Shigwedha
Anna Shimbulu
SipheSihle Nhlabatsi
Nomsa Shongwe
Albert Figueras
Raffaella Ravinetto

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2026.1765077

1,515 views

Original Research

Published on 07 May 2026

Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities

in Pharmaceutical Policy and Regulation

Carlos G. Bernaus
Maria Lilia Bournissen

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2026.1821686

3,607 views
1 citation

Original Research

Published on 09 Mar 2026

Federating AI-related regulations for human therapeutics: an AI-enabled, continuously updating regulatory intelligence system

in Pharmaceutical Policy and Regulation

Rominder Singh
Mukesh Pareek
Michael Prokle
Eduardo Sanchez
Uwe Hohgrawe
Jared R. Auclair

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2026.1718379

2,268 views

Review

Published on 18 Dec 2025

A narrative review on the environmental impact of medicines: from water analysis and in vivo studies to prescribing appropriateness, based on European and Italian legal frameworks

in Pharmaceutical Policy and Regulation

Irene Cristini
Elisabetta Poluzzi
Federica Soardo
Salvatore Crisafulli
Stefano Polesello
Ursula Kirchmayer
Marco Milani
Francesca Russo
Michele Nicoletti
Giovanna Scroccaro

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1681648

3,178 views
3 citations

Review

Published on 17 Dec 2025

Pharmacovigilance and bioethics: the importance of a neglected relationship

in Pharmaceutical Policy and Regulation

Giuseppe Alvaro
Michael Müller
Richa Chhibber
Robert Fuentes

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1698515

3,718 views

Methods

Published on 26 May 2025

Federated learning: a privacy-preserving approach to data-centric regulatory cooperation

in Pharmaceutical Policy and Regulation

Alexander Horst
Paul Loustalot
Sanjeev Yoganathan
Ting Li
Joshua Xu
Weida Tong
David Schneider
Nicolas Löffler-Perez
Erminio Di Renzo
Michael Renaudin

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579922

11,337 views
12 citations

7 articles

articles

Methodological comparisons for benefit-risk assessment in complex decision-making: applications and insights from a case study

Strengthening pharmacovigilance and regulatory capacity in Southern Africa (SPaRCS): achievements, experiences and lessons learned from a participatory action learning project

Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities

Federating AI-related regulations for human therapeutics: an AI-enabled, continuously updating regulatory intelligence system

A narrative review on the environmental impact of medicines: from water analysis and in vivo studies to prescribing appropriateness, based on European and Italian legal frameworks

Pharmacovigilance and bioethics: the importance of a neglected relationship

Federated learning: a privacy-preserving approach to data-centric regulatory cooperation