{"entity":{"id":"anmdmr","kind":"institution","name":"National Agency for Medicines and Medical Devices of Romania (ANMDMR)","aka":["Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România","ANMDMR","ANM Romania"],"tldr":"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.","summary":"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.\n\nUnder 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.","asOf":"2026-11-04","links":[{"label":"ANMDMR: evaluare tehnologii medicale","url":"https://www.anm.ro/medicamente-de-uz-uman/evaluare-tehnologii-medicale/"},{"label":"Ordinul MS nr. 861/2014, consolidated to July 2020, articles 6 to 8 and annexes 1, 2 and 5 (PDF)","url":"https://www.anm.ro/_/EVALUARE%20TEHNOLOGII%20MEDICALE/ORDIN%20Nr.%20861%20din%2023%20iulie%202014.pdf"},{"label":"OECD/EC, Country Cancer Profile Romania 2025, section 5.1 (PDF, Internet Archive copy)","url":"https://web.archive.org/web/2026/https://cancer-inequalities.jrc.ec.europa.eu/sites/default/files/docs/ccp2025/ec-oecd-ro-2024-1682-en.pdf"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["cnas-romania","ema"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Bucharest","country":"RO","lat":44.467,"lng":26.073,"institutionType":"government","website":"https://www.anm.ro","programs":["Health technology assessment for the reimbursed medicines list","Clinical trial authorisation","Pharmacovigilance","Strategic Plan on Clinical Studies (2024)"]},"route":"/institutions/anmdmr/","neighbours":{"institution":[{"id":"ema","kind":"institution","name":"European Medicines Agency","route":"/institutions/ema/"},{"id":"cnas-romania","kind":"institution","name":"National Health Insurance House of Romania (Casa Națională de Asigurări de Sănătate)","route":"/institutions/cnas-romania/"}]}}