EMA is summarizing the results of 2025 and making plans for 2026

In 2025, the European regulator registered 104 new drugs, which is an absolute record in the entire history of the agency. At the same time, 40 % of medicines contain new active ingredients. 

Among the most significant approvals are:

• a drug that slows the progression of type 1 diabetes (Teizeild (teplizumab) from Sanofi).

• a breakthrough therapy drug for the treatment of rare muscular dystrophy (Duvyzat (givinostat) from Italfarmaco). 

In addition, the EU has approved the first vaccine for the treatment of chikungunya fever (Vimkunya from Bavarian Nordic A/S). 

Chikungunya fever is a viral infection transmitted to humans through the bites of Aedes mosquitoes, which are exploring new territories due to climate change. The name "chikungunya" means "crooked" in the language of the East African Makonde people, conveying the appearance of those suffering from this disease. The infection causes fever, rash, severe joint, muscle, and headaches. 

In addition to the work related to the approval of drugs to the market, the EMA has adopted a number of important innovations. One of them concerned azithromycin medicine, an antibiotic prescribed for respiratory tract infections. Previously, it was prescribed everywhere without any tests, now documentary confirmation of the bacterial origin of the infection will be required before prescribing the drug.

The regulator keeps up with the times and actively uses modern technologies in its practice. Thus, the department has launched a service that allows tracking the shortage of critically important drugs. It collects data from all factories and distributors in EU member states in real time, predicting drug shortages in a few months.

In addition, against the background of the increasing popularity of drugs for the treatment of type 2 diabetes and obesity, the regulator conducted a social media campaign to raise awareness about the safe and responsible use of GLP-1 receptor agonists. In October 2025, bloggers actively published related content and interacted with subscribers through quizzes and surveys.

The EMA has identified three priority goals for 2026:

• Modernization of the drug registration system due to modern technologies and AI.

• Increased support for biotech startups.

• Investing in professional development of the European regulatory network.