Corina Daniela Negrila, Luana-Maria Gherasie, Sebastian Mihai Armean, Petru Armean
OBJECTIVES: This scoping review aimed to map European and Romanian pharmaceutical legislation and policy-related evidence and to examine how legislative harmonization translates into access outcomes in Romania. ELIGIBILITY CRITERIA: Legislative documents, institutional reports, market analyses, and peer-reviewed studies addressing pharmaceutical regulation, pricing, reimbursement, and access to medicines (2000-2024). SOURCES OF EVIDENCE: EUR-Lex, the Romanian Legislative Portal, PubMed, Scopus, Google Scholar, and institutional sources (European Commission, OECD, WHO, EFPIA, NAMMDR, CNAS). CHARTING METHODS: Data were extracted using a standardized charting form and synthesized narratively across thematic domains (regulatory harmonization, pricing and reimbursement, medicine shortages, comparative EU indicators, and health system implications). RESULTS: Fifty sources were included. The mapped evidence consistently identified three dominant patterns: (1) prolonged time-to-availability for centrally authorized medicines, with mean delays exceeding 800 days in Romania compared with approximately 578 days at EU level; (2) limited availability of innovative therapies, particularly in oncology (approximately 20% availability in Romania versus around 50% EU average); and (3) recurrent medicine shortages associated with low-price regulation and parallel export dynamics. Evidence gaps include limited Romania-specific empirical evaluation of the causal effects of individual policy levers (e.g., external reference pricing, reimbursement timelines, clawback mechanisms). CONCLUSIONS: Legislative harmonization alone has not ensured equitable or timely access to medicines in Romania. The evidence suggests that national pricing, reimbursement, and supply governance mechanisms mediate the relationship between EU regulation and real-world patient access, highlighting the need for targeted policy reforms and further empirical investigation.