Expert comment: Updated EU pharmacovigilance regulation – What has changed?
On 12 February 2026, the updated EU pharmacovigilance regulation became fully implemented. This regulation contains several important changes aimed at improving efficiency, clarity and compliance within pharmacovigilance systems. Below is a summary of some of the key updates. Key updates 1. Pharmacovigilance System Master File (PSMF)Only significant deviations from established pharmacovigilance procedures, along with their […]
Expert comment: European Biotech Act to strengthen biotechnology and manufacturing sectors
On 16 December 2025 the European Commission published a proposal for a framework of measures to strengthen the Union’s biotechnology and biomanufacturing sectors particularly in the area of health; the so-called Biotech Act. Background EU has a strong scientific research base in biotechnology but is facing issues with taking the early-stage research of these products […]