The European Medicines Agency (EMA) recently published their key achievements and trends overview for 2025. The highlights of this overview:
Innovation in Medicines
In 2025, the EMA’s scientific committees recommended 104 medicines for marketing authorisation across the European Union (EU), of which 38 contain new active substances that had never before been authorised in the EU. These include ground-breaking treatments such as:
- A first-in-class medicine to delay onset of type 1 diabetes (stage 3) in both children and adults
- The first treatment for non-cystic fibrosis bronchiectasis
- The first oral medicine for postpartum depression after childbirth
Addressing rare and unmet needs
16 medicines for rare diseases were recommended, including the first authorised treatment for Wiskott-Aldrich syndrome and a novel gene therapy topical gel for dystrophic epidermolysis bullosa.
Expanding access and sustainability
EMA also supported 41 new biosimilar recommendations, strengthening competition, improving affordability, and enhancing access to vital therapies. Biosimilars are a core part of sustainable healthcare systems across Europe.
Critical, science-based assessment
EMA issued 7 negative opinions, and 22 applications were withdrawn during the Marketing Authorisation Application procedure. Often this is resulting from the fact that, based on available evidence, the benefits did not sufficiently outweigh the risks for these products at this stage of evaluation.
EMA’s evaluation process is rigorous, science-based, and patient-focused. It shows that decisions are not just about approvals, but also about ensuring that only medicines meeting clear standards of efficacy and safety move forward, and that sponsors, regulators and stakeholders interact dynamically to ultimately improve outcomes for patients.
Do you need support with your scientific advice, regulatory submission, or other activities in relation to your submissions to EMA? Contact us at [email protected].
