# Tested on patients in Romania, reimbursed there years later Clinical trials and reimbursed medicines in Romania Since 2001, 200 new medicines have been tested in Phase 3 trials, the last stage before approval, with sites in Romania. The trials began before the European Union approved the medicines. Romania’s list of reimbursed medicines, paid for in full or in part by public health insurance, includes 113 of them (version of 1 April 2026). For half of the 103 approved between 2010 and 2020, reimbursement came more than five years and three months after European approval, or has not come yet. ## How long does a medicine tested in Romania take to be reimbursed there? A European Commission approval is valid from day one in every EU country, Romania included. One more step separates it from patients: the medicine has to enter the list in Government Decision 720/2008, the list of medicines that Romania’s National Health Insurance House pays for in full or in part. For a new medicine, the company that holds it files a request with Romania’s National Medicines Agency, the agency evaluates it, and the government adds it to the list by decision. Of the 140 medicines approved between 2010 and 2023 that had been tested in Romania first, only 16 entered the list within two years of European approval. Of the 109 that have had at least five years since, 52 were on it within five years. Of the 61 with at least ten years, 44. The latest version of the list is that of 1 April 2026. Medicines for cancer and autoimmune diseases get there faster: of those with at least five years since approval, 63% were reimbursed within five years. Of all the others, from diabetes to heart and lung disease, only 29%. The agency’s scorecard, as currently in force (consolidated in October 2025), also looks at what other countries do: one criterion gives 25 points if the medicine is reimbursed in at least 14 EU member states and the UK, and inclusion without conditions requires, among other things, at least 80 points. Another criterion can give up to 45 points, in place of those for the French, British and German evaluations, to a company that submits the authorisation and report of a clinical trial of the medicine run in Romania for the disease it wants reimbursed. In the 2017 version, the same criterion required studies started in Romania specifically for the evaluation. ## Which medicines were tested in your city? Phase 3 trials are usually the last before approval: the new medicine is compared, in studies of hundreds or thousands of participants, with the usual treatment or a placebo. ClinicalTrials.gov, the public registry run by the US National Library of Medicine, lists 1,963 company-funded trials registered as Phase 3 with at least one site in Romania, in 72 places. Some are extension studies or combine Phases 2 and 3. The hospital is rarely named: in 5,693 of the 10,612 Romanian site records, the name is missing or generic, such as “Research Site” or “GSK Investigational Site”. The same hospital can appear in several trials. That is why the map stops at the city, and a place on it means a trial listed a site there. ## Four medicines, four journeys Every thread above has a story with exact dates. These four show the four ways it can end. - Reimbursed in under two years. Opdivo (nivolumab), for cancer. Its earliest trial with Romanian sites began in October 2012. Its trials had sites in București, Cluj-Napoca, Timișoara, Iași and three more. The EU approved it on 19 June 2015. It entered Romania’s reimbursed list on 4 April 2017, one year and nine months later. - Reimbursed after three years and 11 months. Zeposia (ozanimod), for autoimmune disease. Its earliest trial with Romanian sites began in September 2012. Its trials had sites in București, Cluj-Napoca, Timișoara, Craiova and five more. The EU approved it on 20 May 2020. It entered Romania’s reimbursed list on 1 May 2024, three years and 11 months later. - Evaluated, still not reimbursed. Latuda (lurasidone), for brain and mind. Its earliest trial with Romanian sites began in October 2007. Its trials had sites in București, Cluj-Napoca, Timișoara, Iași and eight more. The EU approved it on 21 March 2014. It is not on the list of 1 April 2026, 12 years after approval. The agency published an evaluation report in 2019. - Not reimbursed, no evaluation published. Mounjaro (tirzepatide), for diabetes. Its earliest trial with Romanian sites began in November 2018. Its trials had sites in București, Timișoara, Iași, Craiova and 10 more. The EU approved it on 15 September 2022. It is not on the list of 1 April 2026, three years and seven months after approval. The agency’s page shows no evaluation report for it. ## Which of them are still missing from the list? Of the 140 approved between 2010 and 2023, 48 are not in the list’s version of 1 April 2026. For 19 of them the agency has published at least one evaluation report naming the substance. An evaluation usually starts at the company’s request; the agency can also start one itself, and a report may cover only one disease or form of the medicine. For the other 29, the agency’s page shows no report. The list says what Romania’s health insurance pays for, on prescription and through national health programmes. Absence from it does not show whether a patient can get the medicine another way. And a substance on the list is not necessarily reimbursed for every disease. ## All 200 medicines In order of EU approval, from 2023 backwards. “First trial” is the date the earliest trial with Romanian sites began, anywhere in the world. Medicines approved since 2024 come last: they are too recent to say anything about the wait. - Ebglyss (lebrikizumab), skin: approved in the EU 16 November 2023; not on the list of 1 April 2026 - Vanflyta (quizartinib), cancer: approved in the EU 6 November 2023; not on the list of 1 April 2026 - Jaypirca (pirtobrutinib), cancer: approved in the EU 30 October 2023; not on the list of 1 April 2026 - Tevimbra (tislelizumab), cancer: approved in the EU 15 September 2023; not on the list of 1 April 2026 - Aquipta (atogepant), brain and mind: approved in the EU 11 August 2023; not on the list of 1 April 2026 - Omvoh (mirikizumab), autoimmune disease: approved in the EU 26 May 2023; not on the list of 1 April 2026 - Tibsovo (ivosidenib), cancer: approved in the EU 4 May 2023; reimbursed since 1 April 2026 - Vafseo (vadadustat), heart and blood: approved in the EU 24 April 2023; not on the list of 1 April 2026 - Sotyktu (deucravacitinib), autoimmune disease: approved in the EU 24 March 2023; reimbursed since 1 April 2026 - Imjudo (tremelimumab), cancer: approved in the EU 20 February 2023; reimbursed since 1 April 2026 - Eladynos (abaloparatide), hormones: approved in the EU 12 December 2022; not on the list of 1 April 2026 - Opdualag (relatlimab + nivolumab), cancer: approved in the EU 15 September 2022; not on the list of 1 April 2026 - Mounjaro (tirzepatide), diabetes: approved in the EU 15 September 2022; not on the list of 1 April 2026 - Scemblix (asciminib), cancer: approved in the EU 25 August 2022; reimbursed since 1 June 2024 - Rayvow (lasmiditan), brain and mind: approved in the EU 17 August 2022; not on the list of 1 April 2026 - Pepaxti (melphalan flufenamide), cancer: approved in the EU 17 August 2022; not on the list of 1 April 2026 - Zokinvy (lonafarnib), other: approved in the EU 18 July 2022; not on the list of 1 April 2026 - Orgovyx (relugolix), cancer: approved in the EU 29 April 2022; reimbursed since 1 December 2025 - Padcev (enfortumab vedotin), cancer: approved in the EU 13 April 2022; not on the list of 1 April 2026 - Kerendia (finerenone), heart and blood: approved in the EU 16 February 2022; not on the list of 1 April 2026 - Saphnelo (anifrolumab), autoimmune disease: approved in the EU 14 February 2022; reimbursed since 1 May 2024 - Skytrofa (lonapegsomatropin), hormones: approved in the EU 11 January 2022; not on the list of 1 April 2026 - Cibinqo (abrocitinib), skin: approved in the EU 9 December 2021; reimbursed since 1 December 2025 - Brukinsa (zanubrutinib), cancer: approved in the EU 22 November 2021; reimbursed since 1 December 2025 - Minjuvi (tafasitamab), cancer: approved in the EU 26 August 2021; reimbursed since 1 April 2026 - Evrenzo (roxadustat), heart and blood: approved in the EU 18 August 2021; not on the list of 1 April 2026 - Enspryng (satralizumab), autoimmune disease: approved in the EU 24 June 2021; reimbursed since 1 June 2024 - Koselugo (selumetinib), cancer: approved in the EU 17 June 2021; reimbursed since 1 December 2022 - Ponvory (ponesimod), autoimmune disease: approved in the EU 19 May 2021; not on the list of 1 April 2026 - Orladeyo (berotralstat), heart and blood: approved in the EU 30 April 2021; reimbursed since 1 December 2025 - Jemperli (dostarlimab), cancer: approved in the EU 21 April 2021; not on the list of 1 April 2026 - Sogroya (somapacitan), hormones: approved in the EU 31 March 2021; not on the list of 1 April 2026 - Vazkepa (icosapent ethyl), heart and blood: approved in the EU 26 March 2021; reimbursed since 1 April 2026 - Nexpovio (selinexor), cancer: approved in the EU 26 March 2021; not on the list of 1 April 2026 - Retsevmo (selpercatinib), cancer: approved in the EU 11 February 2021; reimbursed since 1 December 2025 - Enhertu (trastuzumab deruxtecan), cancer: approved in the EU 18 January 2021; reimbursed since 1 May 2023 - Xofluza (baloxavir marboxil), infections: approved in the EU 7 January 2021; not on the list of 1 April 2026 - Calquence (acalabrutinib), cancer: approved in the EU 5 November 2020; reimbursed since 1 December 2022 - Jyseleca (filgotinib), autoimmune disease: approved in the EU 24 September 2020; reimbursed since 1 May 2024 - Piqray (alpelisib), cancer: approved in the EU 27 July 2020; reimbursed since 1 April 2026 - Daurismo (glasdegib), cancer: approved in the EU 26 June 2020; reimbursed since 1 April 2022 - Zeposia (ozanimod), autoimmune disease: approved in the EU 20 May 2020; reimbursed since 1 May 2024 - Nilemdo (bempedoic acid), heart and blood: approved in the EU 1 April 2020; not on the list of 1 April 2026 - Nubeqa (darolutamide), cancer: approved in the EU 27 March 2020; reimbursed since 1 December 2025 - Tavlesse (fostamatinib), heart and blood: approved in the EU 9 January 2020; not on the list of 1 April 2026 - Rinvoq (upadacitinib), autoimmune disease: approved in the EU 16 December 2019; reimbursed since 1 February 2022 - Evenity (romosozumab), bones: approved in the EU 9 December 2019; not on the list of 1 April 2026 - Libtayo (cemiplimab), cancer: approved in the EU 28 June 2019; reimbursed since 1 February 2022 - Doptelet (avatrombopag), heart and blood: approved in the EU 20 June 2019; reimbursed since 1 December 2025 - Esperoct (turoctocog alfa pegol), heart and blood: approved in the EU 20 June 2019; reimbursed since 1 May 2023 - Skyrizi (risankizumab), autoimmune disease: approved in the EU 26 April 2019; reimbursed since 1 January 2021 - Erleada (apalutamide), cancer: approved in the EU 14 January 2019; reimbursed since 1 August 2021 - Verzenios (abemaciclib), cancer: approved in the EU 26 September 2018; reimbursed since 1 January 2021 - Imfinzi (durvalumab), cancer: approved in the EU 21 September 2018; reimbursed since 1 January 2021 - Nerlynx (neratinib), cancer: approved in the EU 31 August 2018; not on the list of 1 April 2026 - Vyxeos liposomal (daunorubicin + cytarabine), cancer: approved in the EU 23 August 2018; not on the list of 1 April 2026 - Rxulti (brexpiprazole), brain and mind: approved in the EU 26 July 2018; not on the list of 1 April 2026 - Rubraca (rucaparib), cancer: approved in the EU 23 May 2018; not on the list of 1 April 2026 - Hemlibra (emicizumab), heart and blood: approved in the EU 23 February 2018; reimbursed since 1 June 2021 - Ozempic (semaglutide), diabetes: approved in the EU 8 February 2018; reimbursed since 1 June 2020 - Fasenra (benralizumab), lungs: approved in the EU 8 January 2018; reimbursed since 1 June 2020 - Ocrevus (ocrelizumab), autoimmune disease: approved in the EU 8 January 2018; reimbursed since 1 June 2020 - Dupixent (dupilumab), skin: approved in the EU 26 September 2017; reimbursed since 1 January 2021 - Tecentriq (atezolizumab), cancer: approved in the EU 20 September 2017; reimbursed since 1 June 2020 - Bavencio (avelumab), cancer: approved in the EU 18 September 2017; reimbursed since 16 October 2019 - Fotivda (tivozanib hydrochloride monohydrate), cancer: approved in the EU 24 August 2017; reimbursed since 1 March 2022 - Maviret (glecaprevir + pibrentasvir), infections: approved in the EU 26 July 2017; reimbursed since 1 February 2022 - Reagila (cariprazine), brain and mind: approved in the EU 13 July 2017; reimbursed since 1 May 2023 - Kevzara (sarilumab), autoimmune disease: approved in the EU 23 June 2017; not on the list of 1 April 2026 - Refixia (nonacog beta pegol), heart and blood: approved in the EU 2 June 2017; not on the list of 1 April 2026 - Xeljanz (tofacitinib), autoimmune disease: approved in the EU 22 March 2017; reimbursed since 16 October 2019 - Olumiant (baricitinib), autoimmune disease: approved in the EU 13 February 2017; reimbursed since 23 March 2018 - Venclyxto (venetoclax), cancer: approved in the EU 4 December 2016; reimbursed since 31 May 2018 - Ibrance (palbociclib), cancer: approved in the EU 9 November 2016; reimbursed since 31 May 2018 - Cinqaero (reslizumab), lungs: approved in the EU 15 August 2016; not on the list of 1 April 2026 - Darzalex (daratumumab), cancer: approved in the EU 20 May 2016; reimbursed since 23 March 2018 - Uptravi (selexipag), heart and blood: approved in the EU 12 May 2016; reimbursed since 1 April 2022 - Empliciti (elotuzumab), cancer: approved in the EU 11 May 2016; not on the list of 1 April 2026 - Taltz (ixekizumab), autoimmune disease: approved in the EU 25 April 2016; reimbursed since 3 October 2017 - Tagrisso (osimertinib), cancer: approved in the EU 1 February 2016; reimbursed since 4 July 2017 - Nucala (mepolizumab), lungs: approved in the EU 1 December 2015; not on the list of 1 April 2026 - Blincyto (blinatumomab), cancer: approved in the EU 23 November 2015; reimbursed since 23 March 2018 - Kyprolis (carfilzomib), cancer: approved in the EU 19 November 2015; reimbursed since 3 October 2017 - Praluent (alirocumab), heart and blood: approved in the EU 23 September 2015; reimbursed since 1 June 2020 - Intuniv (guanfacine), brain and mind: approved in the EU 17 September 2015; not on the list of 1 April 2026 - Repatha (evolocumab), heart and blood: approved in the EU 17 July 2015; reimbursed since 1 August 2021 - Lixiana (edoxaban), heart and blood: approved in the EU 19 June 2015; reimbursed since 1 August 2021 - Opdivo (nivolumab), cancer: approved in the EU 19 June 2015; reimbursed since 4 April 2017 - Lenvima (lenvatinib), cancer: approved in the EU 28 May 2015; not on the list of 1 April 2026 - Akynzeo (netupitant + palonosetron), digestion, metabolism: approved in the EU 27 May 2015; reimbursed since 1 January 2021 - Xadago (safinamide), brain and mind: approved in the EU 23 February 2015; not on the list of 1 April 2026 - Cerdelga (eliglustat), digestion, metabolism: approved in the EU 19 January 2015; reimbursed since 31 May 2018 - Otezla (apremilast), autoimmune disease: approved in the EU 15 January 2015; reimbursed since 1 June 2021 - Cosentyx (secukinumab), autoimmune disease: approved in the EU 14 January 2015; reimbursed since 28 April 2017 - Cyramza (ramucirumab), cancer: approved in the EU 19 December 2014; reimbursed since 31 May 2018 - Lynparza (olaparib), cancer: approved in the EU 16 December 2014; reimbursed since 9 August 2016 - Trulicity (dulaglutide), diabetes: approved in the EU 21 November 2014; reimbursed since 31 May 2018 - Vargatef (nintedanib), cancer: approved in the EU 21 November 2014; reimbursed since 1 March 2017 - Zydelig (idelalisib), cancer: approved in the EU 18 September 2014; not on the list of 1 April 2026 - Gazyvaro (obinutuzumab), cancer: approved in the EU 22 July 2014; reimbursed since 1 March 2017 - Plegridy (peginterferon beta-1a), autoimmune disease: approved in the EU 18 July 2014; reimbursed since 1 June 2020 - Laventair Ellipta (umeclidinium bromide + vilanterol), lungs: approved in the EU 8 May 2014; not on the list of 1 April 2026 - Incruse Ellipta (umeclidinium bromide), lungs: approved in the EU 28 April 2014; not on the list of 1 April 2026 - Cometriq (cabozantinib), cancer: approved in the EU 21 March 2014; reimbursed since 1 June 2020 - Latuda (lurasidone), brain and mind: approved in the EU 21 March 2014; not on the list of 1 April 2026 - Tecfidera (dimethyl fumarate), autoimmune disease: approved in the EU 30 January 2014; reimbursed since 1 January 2021 - Tivicay (dolutegravir), infections: approved in the EU 16 January 2014; reimbursed since 17 August 2020 - Opsumit (macitentan), heart and blood: approved in the EU 20 December 2013; reimbursed since 23 October 2015 - Brintellix (vortioxetine), brain and mind: approved in the EU 18 December 2013; reimbursed since 1 May 2023 - Invokana (canagliflozin), diabetes: approved in the EU 15 November 2013; not on the list of 1 April 2026 - Kadcyla (trastuzumab emtansine), cancer: approved in the EU 15 November 2013; reimbursed since 4 July 2017 - Relvar Ellipta (fluticasone furoate + vilanterol), lungs: approved in the EU 13 November 2013; not on the list of 1 April 2026 - Aubagio (teriflunomide), autoimmune disease: approved in the EU 26 August 2013; reimbursed since 9 August 2016 - Perjeta (pertuzumab), cancer: approved in the EU 4 March 2013; reimbursed since 31 May 2018 - Tresiba (insulin degludec), diabetes: approved in the EU 20 January 2013; reimbursed since 16 October 2019 - Betmiga (mirabegron), bladder and prostate: approved in the EU 20 December 2012; not on the list of 1 April 2026 - Eylea (aflibercept), cancer: approved in the EU 21 November 2012; reimbursed since 9 August 2016 - Forxiga (dapagliflozin), diabetes: approved in the EU 11 November 2012; reimbursed since 7 November 2014 - Adcetris (brentuximab vedotin), cancer: approved in the EU 25 October 2012; reimbursed since 23 October 2015 - Enurev Breezhaler (glycopyrronium bromide), lungs: approved in the EU 28 September 2012; reimbursed since 7 November 2014 - Dacogen (decitabine), cancer: approved in the EU 20 September 2012; reimbursed since 15 May 2014 - Inlyta (axitinib), cancer: approved in the EU 3 September 2012; reimbursed since 9 August 2016 - Fycompa (perampanel), brain and mind: approved in the EU 23 July 2012; not on the list of 1 April 2026 - Bretaris Genuair (aclidinium bromide), lungs: approved in the EU 20 July 2012; not on the list of 1 April 2026 - Signifor (pasireotide), hormones: approved in the EU 24 April 2012; reimbursed since 15 May 2014 - Zelboraf (vemurafenib), cancer: approved in the EU 17 February 2012; reimbursed since 4 April 2017 - Caprelsa (vandetanib), cancer: approved in the EU 16 February 2012; reimbursed since 1 September 2019 - Edurant (rilpivirine), infections: approved in the EU 28 November 2011; reimbursed since 17 August 2020 - Trajenta (linagliptin), diabetes: approved in the EU 23 August 2011; not on the list of 1 April 2026 - Benlysta (belimumab), autoimmune disease: approved in the EU 13 July 2011; reimbursed since 31 May 2018 - Yervoy (ipilimumab), cancer: approved in the EU 13 July 2011; reimbursed since 31 May 2018 - Eliquis (apixaban), heart and blood: approved in the EU 18 May 2011; reimbursed since 23 October 2015 - Jevtana (cabazitaxel), cancer: approved in the EU 17 March 2011; reimbursed since 29 August 2018 - Halaven (eribulin), cancer: approved in the EU 17 March 2011; reimbursed since 1 May 2023 - Gilenya (fingolimod), autoimmune disease: approved in the EU 17 March 2011; reimbursed since 1 June 2020 - Brilique (ticagrelor), heart and blood: approved in the EU 3 December 2010; reimbursed since 3 October 2017 - Ruconest (conestat alfa), heart and blood: approved in the EU 28 October 2010; reimbursed since 1 December 2022 - Daxas (roflumilast), lungs: approved in the EU 5 July 2010; not on the list of 1 April 2026 - Arzerra (ofatumumab), cancer: approved in the EU 19 April 2010; reimbursed since 15 May 2014 - Revolade (eltrombopag), heart and blood: approved in the EU 11 March 2010; reimbursed since 1 March 2017 - Oslif Breezhaler (indacaterol), lungs: approved in the EU 29 November 2009; reimbursed since 7 November 2014 - Ilaris (canakinumab), autoimmune disease: approved in the EU 23 October 2009; reimbursed since 1 December 2022 - Cimzia (certolizumab pegol), autoimmune disease: approved in the EU 1 October 2009; reimbursed since 7 November 2014 - Simponi (golimumab), autoimmune disease: approved in the EU 1 October 2009; reimbursed since 7 November 2014 - Onglyza (saxagliptin), diabetes: approved in the EU 30 September 2009; reimbursed since 7 November 2014 - Samsca (tolvaptan), heart and blood: approved in the EU 2 August 2009; reimbursed since 1 April 2022 - Victoza (liraglutide), diabetes: approved in the EU 30 June 2009; reimbursed since 16 October 2019 - Iressa (gefitinib), cancer: approved in the EU 24 June 2009; reimbursed since 1 March 2017 - Zebinix (eslicarbazepine acetate), brain and mind: approved in the EU 21 April 2009; not on the list of 1 April 2026 - Conbriza (bazedoxifene), hormones: approved in the EU 17 April 2009; not on the list of 1 April 2026 - Efient (prasugrel), heart and blood: approved in the EU 24 February 2009; not on the list of 1 April 2026 - Firmagon (degarelix), cancer: approved in the EU 17 February 2009; not on the list of 1 April 2026 - RoActemra (tocilizumab), autoimmune disease: approved in the EU 16 January 2009; reimbursed since 7 November 2014 - Xarelto (rivaroxaban), heart and blood: approved in the EU 30 September 2008; reimbursed since 7 November 2014 - Vimpat (lacosamide), brain and mind: approved in the EU 29 August 2008; not on the list of 1 April 2026 - Relistor (methylnaltrexone bromide), digestion, metabolism: approved in the EU 1 July 2008; not on the list of 1 April 2026 - Tyverb (lapatinib), cancer: approved in the EU 10 June 2008; reimbursed since 9 August 2016 - Celsentri (maraviroc), infections: approved in the EU 18 September 2007; reimbursed since 21 December 2009 - Rasilez (aliskiren), heart and blood: approved in the EU 22 August 2007; not on the list of 1 April 2026 - Invega (paliperidone), brain and mind: approved in the EU 24 June 2007; reimbursed since 7 November 2014 - Toviaz (fesoterodine), bladder and prostate: approved in the EU 20 April 2007; not on the list of 1 April 2026 - Elaprase (idursulfase), digestion, metabolism: approved in the EU 8 January 2007; reimbursed since 25 July 2011 - Nexavar (sorafenib), cancer: approved in the EU 19 July 2006; reimbursed since 27 February 2009 - Tarceva (erlotinib), cancer: approved in the EU 19 September 2005; reimbursed since 27 February 2009 - Erbitux (cetuximab), cancer: approved in the EU 29 June 2004; reimbursed since 27 February 2009 - Abilify (aripiprazole), brain and mind: approved in the EU 4 June 2004; reimbursed since 27 February 2009 - Levemir (insulin detemir), diabetes: approved in the EU 1 June 2004; reimbursed since 27 February 2009 - Icotyde (icotrokinra hydrochloride), autoimmune disease: approved in the EU 18 September 2026; not on the list of 1 April 2026 - Etcamah (camizestrant), cancer: approved in the EU 20 July 2026; not on the list of 1 April 2026 - Redemplo (plozasiran), heart and blood: approved in the EU 19 June 2026; not on the list of 1 April 2026 - Cenrifki (tolebrutinib), autoimmune disease: approved in the EU 19 June 2026; not on the list of 1 April 2026 - Zepzelca (lurbinectedin), cancer: approved in the EU 29 May 2026; not on the list of 1 April 2026 - Imdylltra (tarlatamab), cancer: approved in the EU 29 May 2026; not on the list of 1 April 2026 - Xolremdi (mavorixafor), autoimmune disease: approved in the EU 27 April 2026; not on the list of 1 April 2026 - Palsonify (paltusotine), hormones: approved in the EU 23 April 2026; not on the list of 1 April 2026 - Rhapsido (remibrutinib), autoimmune disease: approved in the EU 23 April 2026; not on the list of 1 April 2026 - Fylrevy (estetrol), hormones: approved in the EU 26 March 2026; not on the list of 1 April 2026 - Exdensur (depemokimab), lungs: approved in the EU 12 February 2026; not on the list of 1 April 2026 - Inluriyo (imlunestrant), cancer: approved in the EU 9 January 2026; not on the list of 1 April 2026 - Teizeild (teplizumab), diabetes: approved in the EU 8 January 2026; not on the list of 1 April 2026 - Imaavy (nipocalimab), autoimmune disease: approved in the EU 28 November 2025; not on the list of 1 April 2026 - Lynkuet (elinzanetant), hormones: approved in the EU 17 November 2025; not on the list of 1 April 2026 - Winlevi (clascoterone), skin: approved in the EU 17 October 2025; not on the list of 1 April 2026 - Tryngolza (olezarsen), heart and blood: approved in the EU 17 September 2025; not on the list of 1 April 2026 - Ziihera (zanidatamab), cancer: approved in the EU 27 June 2025; not on the list of 1 April 2026 - Datroway (datopotamab deruxtecan), cancer: approved in the EU 4 April 2025; not on the list of 1 April 2026 - Welireg (belzutifan), cancer: approved in the EU 12 February 2025; not on the list of 1 April 2026 - Augtyro (repotrectinib), cancer: approved in the EU 13 January 2025; not on the list of 1 April 2026 - Alhemo (concizumab), heart and blood: approved in the EU 13 December 2024; not on the list of 1 April 2026 - Iqirvo (elafibranor), digestion, metabolism: approved in the EU 19 September 2024; not on the list of 1 April 2026 - Vyloy (zolbetuximab), cancer: approved in the EU 19 September 2024; not on the list of 1 April 2026 - Piasky (crovalimab), autoimmune disease: approved in the EU 22 August 2024; reimbursed since 1 April 2026 - Ordspono (odronextamab), brain and mind: approved in the EU 22 August 2024; not on the list of 1 April 2026 - Obgemsa (vibegron), bladder and prostate: approved in the EU 27 June 2024; not on the list of 1 April 2026 - Awiqli (insulin icodec), diabetes: approved in the EU 17 May 2024; not on the list of 1 April 2026 - Zynyz (retifanlimab), cancer: approved in the EU 19 April 2024; not on the list of 1 April 2026 - Velsipity (etrasimod), autoimmune disease: approved in the EU 16 February 2024; not on the list of 1 April 2026 - Omjjara (momelotinib), other: approved in the EU 25 January 2024; not on the list of 1 April 2026 - Krazati (adagrasib), cancer: approved in the EU 5 January 2024; not on the list of 1 April 2026 - Rystiggo (rozanolixizumab), autoimmune disease: approved in the EU 5 January 2024; reimbursed since 1 April 2026 ## What this means for anyone joining a trial Nothing here argues against clinical trials. For many patients a trial is the only way to get a new treatment early, and taking part is voluntary and overseen by ethics committees. This page looks at what comes after the trial: when the medicine, once approved, reaches other patients in the same cities, paid for by public health insurance. The doctor who offers a trial is the best person to ask what treatment remains available once it ends. ## How they were counted The trials. Every interventional Phase 3 trial with a company as lead funder and at least one site in Romania, downloaded from ClinicalTrials.gov (API v2) on 31 October 2026: 1,963. The number of participants in Romania is not given: the registry shows only each trial’s total. The start date is the trial’s, not that of the Romanian site, and a listed site does not by itself prove it enrolled anyone. The medicines. The European Medicines Agency’s list of every centrally authorised medicine (31 October 2026), without generics and biosimilars. For each active substance, the first EU authorisation counts. A medicine is “tested in Romania before approval” if one of the trials above names it among the drugs studied and started no later than the day of EU approval. What was left out. Vaccines, blood products, diagnostic agents and hospital antibiotics (which do not go through this list), older substances already reimbursed in Romania before their EU approval, fixed combinations of substances already approved separately, and medicines withdrawn from the EU market. The reimbursed list. All 53 consolidated versions of Government Decision 720/2008 on legislatie.just.ro, Romania’s official legislation portal, from 27 February 2009 to 1 April 2026. A medicine’s date of entry is the date of the first version that contains it. Since 2014 each version matches one amending decision, so the date is the date that decision applied. Before 2014, versions are up to two years apart and the date can be later than the real one. Names were matched by hand-checked rules, including the list’s own spellings (for example “Trastuzumabum emtasinum”). A medicine reimbursed for any disease counts as listed, even if it was tested in Romania for another. The wait. Counted from EU approval to the first version of the list that contains the medicine. The numbers in the text cover only medicines that have had enough time: “within five years” counts only those approved at least five years before 1 April 2026. The chart’s curves use the Kaplan–Meier method, which also accounts for recently approved medicines still waiting. The evaluation reports. The 987 reports on the Romanian medicines agency’s page, matched by substance name. A report shows the substance was evaluated, possibly for one disease only; its absence shows only that the page has none. A comparison set aside. Medicines tested in Romania make the list more often than those not tested there. The comparison does not account for the company, the disease or the size of the market, so it cannot show whether testing in Romania speeds reimbursement up or slows it down. ## Sources - [ClinicalTrials.gov, API v2: Phase 3 trials with sites in Romania](https://clinicaltrials.gov/search?locStr=Romania&country=Romania&aggFilters=phase:3,funderType:industry,studyType:int) - [European Medicines Agency: list of authorised medicines (JSON)](https://www.ema.europa.eu/en/medicines/download-medicine-data) - [Government Decision 720/2008, with its history of consolidated versions](https://legislatie.just.ro/Public/DetaliiDocument/214309) - [Romanian medicines agency (ANMDMR): health technology assessment reports](https://www.anm.ro/medicamente-de-uz-uman/evaluare-tehnologii-medicale/rapoarte-de-evaluare-a-tehnologiilor-medicale/) - [Health Minister’s Order 861/2014: evaluation criteria and scores (consolidated, October 2025)](https://www.anm.ro/_/ORDINE/Ordin%20861-2014.pdf) - [Administrative boundaries (geo-spatial.org, ANCPI)](https://geo-spatial.org/vechi/download/romania-seturi-vectoriale)