The interplay of legal norms in regulating digital platform mergers: comparative insights from China, ASEAN, and the European Union with policy implications for Thailand. [PDF]
Yaseen M, Phattanasin K.
europepmc +1 more source
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
Unpacking non-transparency: Most physical trading card game and collectible sports card packs failed to disclose probabilities for winning rare prizes. [PDF]
Lo CY, Xiong KX, Xiao LY.
europepmc +1 more source
Regulatory harmonization: Evolution, globalization and future directions
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
Analysis of How the Term "Shall" Is Understood and Applied to the EU-HTA Regulation. [PDF]
Toumi M +5 more
europepmc +1 more source
Implementation and use of risk minimization control tools in the EU: A multistakeholder survey
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
Canada's AI for All strategy has a privacy problem that must be addressed. [PDF]
Spithoff S, Scassa T.
europepmc +1 more source
Paediatric clonidine medication errors: Findings from a multicentre French study
Aims This study aimed to describe the characteristics of medication errors involving clonidine in paediatric patients and reported to French Network of Pharmacovigilance and Poison Control Centres. Methods This retrospective observational study analysed clonidine‐related medication errors reported between 1985 and June 2024 in patients under 12 years ...
Eve‐Marie Thillard +8 more
wiley +1 more source
Impacts of Food Adulteration and Contamination: Health, Socio-Economic, and Legislative Aspects. [PDF]
Momtaz M, Bubli SY, Khan MS.
europepmc +1 more source

