British Journal of Clinical Pharmacology, EarlyView.Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley +1 more source
(Global) single market for data? Exploring data cosmopolitanism as a solidarity-based regulatory approach to the european health data space. [PDF]
Data BriefMusidlowska M, Fierens M, Maria Rosal I.
europepmc +1 more source
How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU
British Journal of Clinical Pharmacology, EarlyView.The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
Professional Independence as the Foundation of Modern Pharmacy Practice: A Comparative Analysis of Deontological Frameworks Across 30 European Jurisdictions. [PDF]
Healthcare (Basel)Finta H +5 more
europepmc +1 more source
Zuranolone: A case study in (regulatory) rush to judgement?
British Journal of Clinical Pharmacology, EarlyView.Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove +4 more
wiley +1 more source
When hospitals build their own AI: a comparison of the EU and US regulatory framework. [PDF]
BMJ Digit Health AiPalmieri S, Minssen T, Cohen IG.
europepmc +1 more source
Regulatory harmonization: Evolution, globalization and future directions
British Journal of Clinical Pharmacology, EarlyView.Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
Protecting Companion Animals Under Chinese Criminal Law: Current Practice and Future Paths. [PDF]
Animals (Basel)Liu C, Su D, Nie A.
europepmc +1 more source
Implementation and use of risk minimization control tools in the EU: A multistakeholder survey
British Journal of Clinical Pharmacology, EarlyView.Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink +21 more
wiley +1 more source