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Background and Importance Early Access Authorisation (EAA) and Compassionate use authorisation (CUA) are key regulatory pathways to provide innovative medicines to patients. Hospital pharmacies are central to the preparation, traceability, and reporting of these drugs, which generates valuable real-world data.Aim and Objectives The aim was to describe the characteristics of patients and medicines managed under EAA and CUA in our pharmacy at a cancer centre over 18 months.Material and Methods We retrospectively collected all drug preparations declared by our pharmacy under EAA or CUA between January 2024 and June 2025. Data included drug name, pharmaceutical class, route of administration, regulatory status (EAA or CUA), indication, and medical committee. Preparations were grouped by therapeutic area and analysed descriptively.Results Over the study period, 4444 preparations were dispensed for 695 patients. A total of 28 drugs were used, mainly injectables (26/28). The main therapeutic classes were immunotherapies (16 drugs, 57%) and antibody–drug conjugates (five drugs, 18%), with smaller contributions from chemotherapies, tyrosine kinase inhibitors, and others.Most patients were treated in oncology-related committees: breast diseases (387 patients, 2635 preparations), haematology (54, 532), urology (55, 426), digestive tract (46, 201), chest diseases (58, 214), and gynaecology (37, 203). Paediatrics accounted for 58 patients (223 preparations). Endocrinology (3, 9) and dermatology (1, 1) represented minor activity.Regulatory status covered 13 drugs in CUA and 19 in EAA; by June 2025, eight drugs had transitioned to routine care. In total, 50 different indications were managed, mainly in paediatrics (10), haematology (nine), digestive tract (eight), and breast diseases (five).Conclusion and Relevance Our analysis highlights the major involvement of hospital pharmacy in EAA and CUA. This analysis is a first step to our future analysis of 5 years. Preparations allow to give access to 6% of our new patients to the most advance treatment. Paediatrics has the most indications; we will investigate this further. Beyond operational impact, these data could help anticipate transitions to routine care and support the collection of real-world evidence to complement clinical trial findings, thus contributing to drug evaluation and market access strategies.Conflict of Interest No conflict of interest