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Romania's medicines regulator and its health technology assessment body. New cancer medicines are authorised for the whole EU; the agency then scores each one against a points scale to decide whether it can enter the reimbursed list, unconditionally or on condition of a cost-volume contract.
The Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România authorises medicines and clinical trials in Romania and runs pharmacovigilance; new cancer medicines are authorised once for the whole European Union through the European Medicines Agency's centralised procedure.
Under Ministry of Health order 861/2014 it is also the national authority that carries out health technology assessment and proposes to the Ministry the list of reimbursed medicines, which the Government approves by decision. For a new medicine the order awards points for the assessments of France's HAS, the United Kingdom's NICE or SMC and Germany's IQWiG or G-BA, for the number of EU member states and the United Kingdom that reimburse it (25 points for at least 14), and for cost against a comparator; a clinical trial of the medicine run in Romania, an EUnetHTA assessment or a notified real-world data study can earn 45 points in place of the points for the three foreign assessments. The agency then decides unconditional inclusion, conditional inclusion on the basis of a cost-volume or cost-volume-result contract, or non-inclusion. The OECD and European Commission's 2025 profile notes that in 2024 the agency coordinated Romania's first Strategic Plan on Clinical Studies.
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