« Back to Farmacia Journal 1/2026

SUPPLY CHAIN VULNERABILITY AND REGULATORY GAPS: AN EVALUATION OF DRUG SHORTAGES IN THE ROMANIAN PHARMACEUTICAL MARKET (2008-2024)

OANA-TEODORA CHIRAC ¹, ADRIANA-ELENA TĂEREL ²*, MIHAELA DINU ¹, ROBERT ANCUCEANU 1

Download Full Article PDF

Most studies on medicine shortages have primarily focused on the prevalence and characteristics of affected products. This study assesses supply discontinuities in Romania, with emphasis on supply trends, regulatory frameworks, pricing policies, and their impact on patient access to treatment. The analysis is based on data from the National Catalogue of Human Medicines (CANAMED) and shortage notifications reported by the National Agency for Medicines and Medical Devices. Medicines were classified according to pharmaceutical form, route of administration, and ATC therapeutic class. Temporary and permanent shortages, marketing authorizations, and special needs authorizations were examined as indicators of systemic and regulatory responses to supply imbalances. Between 2017 and 2024, the number of reported shortages increased substantially, with permanent discontinuities accounting for 57.6% of all cases. Special-needs authorizations increased markedly during the COVID-19 pandemic, while oral and parenteral formulations dominated the market. In contrast, alternative dosage forms maintained a limited and stable share. These findings highlight widespread shortages of medicines in Romania and emphasize the need for integrated national and European strategies to strengthen the pharmaceutical system's resilience and ensure equitable access to essential medicines.