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 legislation?

“The agreement on the new pharmaceutical legislation is a historic milestone for medicines regulation in Europe and for patients across the EU, a golden opportunity to become more agile and efficient,” Cooke stated in the release (1).

Cooke said the agency will be using the opportunity provided by the legislation to focus efforts in three areas. The agency will be “reimagining” how it works, and Cooke plans to adapt systems to better handle scientific and technological advancements. Early development and innovation will be supported to enable quicker market authorizations. Investments will also be made in staff and network workforce to build capacity and capabilities.

What drug recommendations were made by EMA?

EMA recommended 104 new drugs in 2025, 40% of which were new active substances. These included the first treatment to delay the onset of stage 3 type 1 diabetes in adults and children aged eight and older. The first treatment for Duchenne muscular dystrophy was also recommended for patients aged six and older who can walk. Europe also got its first Chikungunya vaccine for adolescents aged 12 and older.

EMA also recommended changes to the use of the antibiotic azithromycin to reduce the chance of antimicrobial resistance. Plus, measures were recommended to minimize the risk of suicide with finasteride and dutasteride, which is used to treat androgenetic alopecia in men.

How did EMA collaborate in 2025?

EMA launched the European Shortages Monitoring Platform in January to provide a coordinated system and framework for how the agency works with national authorities and actors in the European Union to ensure that the supply chain of drugs is robust.

The agency coordinated with the European Commission and other regulatory bodies to communicate across channels and worked with content creators to promote safe and responsible use of GLP-1 drugs. “In an environment where misinformation spreads faster than facts, we must embrace innovative approaches to communication and stakeholder engagement,” Cooke stated.

“Europe has always been a place where ideas spark change. It has world-class science and world-class expertise. We need to protect and promote these strengths,” she continued. “We need a Europe where facts matter, innovation thrives, and collaboration wins. The future is ours to shape—let’s shape it together, with science.”

References

1. EMA. Emer Cooke, EMA’s Executive Director: 2025 Achievements in Medicine Regulation. Press Release. Dec. 19, 2025. https://www.ema.europa.eu/en/news/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation
2. European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation
3. EMA. EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation