Expansion of Generic Medicines Authorization in Portugal
928 New Medicines Authorizations Boost Portugal’s Health Access
In 2025, Portugal’s National Authority for Medicines and Health Products (Infarmed) authorized 928 new medicines for market introduction, with generic medicines authorization comprising 79% of the total and underscoring their role in fostering competition and bolstering health system sustainability. National industry contributions were significant, with 236 domestically produced medicines approved, including 38 deemed essential for ensuring continuous supply to priority health needs. This influx particularly strengthened therapeutic areas such as the central nervous system, cardiovascular system, and oncology, while introducing first generics for key drugs to enhance affordability for patients and the National Health Service (SNS).
Generics Surge Drives Competition
The predominance of generic medicines authorization, accounting for 79% of approvals, exemplifies their critical function in health economics by promoting price competition and long-term fiscal sustainability within public health systems. Specific examples include first generics like tafamidis 20 mg soft capsules for central nervous system disorders, mirabegron 50 mg extended-release tablets for genitourinary conditions, and adenosine 30 mg/10 ml perfusion solution for cardiovascular applications, alongside combinations such as paracetamol + caffeine 500 mg + 65 mg soft capsules for analgesia. Antineoplastic and immunomodulator first generics, such as mitomycin 40 mg powder, further highlight targeted expansions in high-cost oncology areas, while antidiabetic options like empagliflozin + metformin and standalone empagliflozin address chronic disease burdens, collectively driving down expenditure for the SNS and improving patient access.
Priority Areas Dominate Approvals
Therapeutic distribution reveals strategic focus on priority areas, with central nervous system agents leading at 22.5% of nationally authorized medicines via national procedures, decentralized procedures (DCP), or mutual recognition procedures (MRP), followed by cardiovascular drugs at 17.8% and hematological agents at 15.3%. Oncology and autoimmune therapies captured 12.7%, endocrine treatments 10.3%, anti-infectives 7.0%, and gastrointestinal medicines 3.0%, reflecting Portugal’s emphasis on prevalent and resource-intensive conditions. This allocation not only aligns with epidemiological needs but also amplifies the economic value of generics and national production in scaling access without proportional cost escalation.
Savings Potential for SNS Sustainability
These authorizations, exemplified by first-to-market entries in oncology, cardiology, and diabetes—could yield substantial savings for the SNS, potentially redirecting resources toward innovative therapies amid rising chronic disease prevalence. This reduced generic medicine costs will improve competition, particularly for high-prevalence areas like cardiovascular and oncologic care comprising over 30% of approvals.
