EMA Director Sees Legislation Revamp as Highlight of 2025

On Dec. 19, 2025, Emer Cooke, executive director of the European Medicines Agency (EMA), published highlights of the agency’s accomplishments in 2025, which marked three decades since its inception. Among EMA’s successes was the recommendation of 104 new drugs during the year, with almost 40% containing a new active substance (1).

Chief among the 2025 events, according to Cooke, is the agreement between the European Commission (EC), the European Parliament, and the Council of the European Union to revamp pharmaceutical legislation (2), which will allow EMA to streamline its procedures (3).

How will EMA shift to address new…