Global Medicines, Different Rules 🌍💊 | EMA Explains Its Role in a 27-System Europe! Medicines may be developed globally — but they are approved and used within very different systems. In this EMA briefing, Steffen Thirstrup, Chief Medical Officer of the European Medicines Agency (EMA), explains why Europe’s medicines regulation cannot be measured against a single external benchmark. While comparisons with the U.S. Food and Drug Administration (FDA) are common, Thirstrup stresses that EMA opera

A Wake-Up Call for Europe 💊 | EMA Promises Faster Drug Approvals with New Pharma Law! Speaking at the European Medicines Agency press briefing on Human Medicines in 2025, Francesca Day, Head of the Therapeutics Area Department at European Medicines Agency, delivers a rare moment of institutional honesty. Europe, she admits, has not always kept pace with the FDA and other global regulators when it comes to approval timelines. But that gap is no longer being ignored. Over the past two years, the

AI Will NOT Replace Regulators 🤖💊 EMA Chief Medical Officer Reveals How AI Will Be Used! Artificial Intelligence is coming to medicines regulation — but not in the way many fear. Speaking at a European Medicines Agency press briefing, Steffen Thirstrup, Chief Medical Officer of the European Medicines Agency (EMA), explains how regulators in Europe and the United States are approaching AI together, guided by shared principles. Thirstrup confirms that EMA and the U.S. Food and Drug Administratio

Mounjaro & Wegovy Go Further ⚖️💊 | EMA Expands Use for Children as Oral Weight-Loss Pills Near! Europe’s most talked-about weight-loss medicines — Mounjaro and Wegovy — are moving into a new phase. Regulators have extended the use of Mounjaro to adolescents and children from the age of 10 with insufficiently controlled type 2 diabetes, a decision with major implications for early-onset obesity and metabolic disease. At the same time, the European Medicines Agency (EMA) is assessing an oral form