Introduction: A New Era Begins Recently, EMA (with the European Commission and Heads of Medicines Agencies) set out new targets intended to make the Europe a more attractive site for clinical research, while improving patient access to innovative medicines. The introduction of the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS) is more than an administrative upgrade. It represents a turning point that is reshaping Europe’s medical research landscape. Sponsors can now submit a single application through CTIS that covers up to 30 European countries at once. So, what has the wealth of data collected during this three-year transition period revealed? Are there surprising patterns hidden within it? Let’s explore the five most striking, counterintuitive, and influential findings The full report is available on the ACT EU website 1. A Surprisingly High Success Rate: Over 98% of Applications Approved Out of 8,661 clinical tria...
I’ve been working in the Korean pharmaceutical industry for over 10 years in global regulatory affairs. Here, I’d like to share insights on the Korean bio industry and global RA.