Infarmed Regulatory Activity: January 2026 Highlights and Impacts on Market Access

Infarmed regulatory activity in January 2026 showcased robust performance by Portugal’s National Authority for Medicines and Health Products, spanning marketing authorizations, clinical trials, public reimbursement, inspections, pharmacovigilance, and enforcement. The agency processed 45 renewals of national marketing authorizations, authorized 47 new medicines, handled 2,508 amendments to existing authorizations, approved all 7 applications for public funding of new active substances or therapeutic indications, and managed 887 notifications of adverse reactions. These efforts, detailed in Infarmed’s official report, support the commitment to safety and timely market access within the National Health Service.

Marketing Surge Drives Therapy Availability

Infarmed regulatory activity excelled in market-entry processes, concluding 45 renewals of national marketing authorizations, approving 47 new medicines, and processing 2,508 amendments. This high volume—over 2,600 requests—ensures ongoing access to established treatments and introduces innovative therapies, streamlining pathways to reduce patient wait times and support market stability.

Public reimbursement decisions targeted new active substances and therapeutic indications, yielding 7 approvals with zero rejections—a perfect 100% rate. This efficiency accelerates access to cutting-edge treatments, aligning clinical evidence with economic evaluations for stronger Health Economics and Outcomes Research (HEOR) outcomes.

Pharmacovigilance and Inspections Strengthen Safety

Infarmed’s pharmacovigilance included approving 7 educational materials, logging 887 adverse reaction notifications, issuing 8 PRAC reports, conducting 54 inspections, and handling 906 licensing acts. Enforcement via 31 infringement proceedings bolsters compliance, integrating national data into European systems for enhanced post-market surveillance.

Clinical Trials Fuel Research Momentum

Authorizing 11 new clinical trials positions Infarmed as a research enabler, generating data vital for future authorizations and reimbursements. This steady pace supports innovation cycles and cost-effectiveness analyses.