“In 2025, Infarmed authorised the introduction of 928 new medicines to the market, in a year marked by a strong contribution from generic medicines and the relevance of the national pharmaceutical industry in providing access to safe, effective, and quality therapies,” the authority states in a press release published on its website.
The National Authority for Medicines and Health Products (Infarmed) adds that, of the total number of medicines authorised, 79% are generic medicines, “confirming the importance of this segment in promoting competition and the sustainability of the health system.”
The report also highlights the authorisation of 236 medicines from the national industry, as well as 38 medicines considered essential, that is, drugs indispensable to the priority health needs of the population and for which a continuous and regular supply must be ensured in the health system.
Infarmed emphasises that the analysis of national medicines approved in 2025, through national procedures and decentralised and mutual recognition procedures, shows a greater representation in priority therapeutic areas.
The central nervous system is particularly prominent, concentrating 22.5% of the total medicines authorised through national procedures, followed by the cardiovascular system (17.8%) and blood-related medicines (15.3%).
“Antineoplastic and immunomodulatory drugs represent 12.7%, reflecting the continued investment in therapies for oncological and autoimmune diseases,” it highlights.
Other relevant areas include hormones and medications used to treat endocrine diseases (10.3%), anti-infectives (7.0%), and medications for the digestive system (3.0%). The remaining therapeutic areas have a more residual distribution.
Infarmed emphasises that, in 2025, the introduction of several first generic medicines to the market was also authorised, expanding the available therapeutic options and contributing to cost reduction for users and the National Health Service (SNS).
Among the first generic medicines authorised in 2025 are Tafamidis, for the central nervous system; Mirabegron, for the genitourinary system; Adenosine, for the cardiovascular system; Paracetamol + caffeine, for analgesics and Antipyretics of the central nervous system; and Mitomycin, included in antineoplastic and immunomodulatory medicines.
Also authorised as first generics were the combination empagliflozin + metformin and empagliflozin, in the group of oral antidiabetics; dienogest + estradiol valerate, in the area of contraceptives; lauromacrogol 400, injectable solution, as a venotropic; edoxaban, in the group of anticoagulants and antithrombotics; as well as atorvastatin and the combination rosuvastatin + ezetimibe, both in the group of lipid-lowering drugs.