O central nervous system assumes particular prominenceaccounting for 22.5% of the total medicines authorized by national procedure, followed by the cardiovascular system (17.8%) and blood-related medicines (15.3%).
Infarmed approved, in 2025, 928 new drugs, including 79% generic, 38 essential and 236 national, with the central nervous system being the area with the greatest representation, according to data from the national medicine authority.
“In 2025, Infarmed authorized the introduction of 928 new medicines onto the market, in a year marked by a strong contribution from generic medicines and the relevance of the national pharmaceutical industry in accessing safe, effective and quality therapies”, says the authority in a statement published on the website.
It also highlights the authorization of 236 nationally manufactured medicines, as well as 38 medicines considered essentialthat is, drugs that are essential to the population’s priority health needs and for which a continuous and regular supply in the health system must be ensured.
Infarmed emphasizes that the analysis of national medicines approved in 2025, by national procedure and by decentralized and mutual recognition procedures, shows greater representation in priority therapeutic areas.
O central nervous system assumes particular prominenceaccounting for 22.5% of the total medicines authorized by national procedure, followed by the cardiovascular system (17.8%) and blood-related medicines (15.3%).
“Antineoplastic and immunomodulatory drugs represent 12.7%, reflecting the continued focus on therapies for oncological and autoimmune diseases”, he highlights.
Other relevant areas include hormones and medications used to treat endocrine diseases (10.3%), anti-infectives (7.0%) and digestive system medications (3.0%). The remaining therapeutic areas have a more residual distribution.
Infarmed highlights that, in 2025, it was also authorized the introduction on the market of several first generic medicinesexpanding the therapeutic options available and contributing to reducing costs for users and the National Health Service (SNS).
Among the first generic medicines authorized in 2025 are tafamidis, in the area of the central nervous system, mirabegron, for the genitourinary system, adenosine, in the area of the cardiovascular system, paracetamol + caffeine, in the area of central nervous system analgesics and antipyretics, and mitomycin, integrated into antineoplastic and immunomodulatory medicines.
The combination of empagliflozin + metformin and empagliflozin, in the group of oral antidiabetics, dienogest + estradiol valerate, in the area of contraceptives, lauromacrogol 400, an injectable solution, as a venotropic agent, edoxaban, in the group of anticoagulants and antithrombotics, as well as atorvastatin and the association rosuvastatin + ezetimibe, both in the antidyslipidemic group.
