Tested on patients in Romania, reimbursed there years later

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.

1. 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.

   See its thread in the chart ↑

2. 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.

   See its thread in the chart ↑

3. 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.

   See its thread in the chart ↑

4. 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.

   See its thread in the chart ↑

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.

The time after each name: from EU approval to 1 April 2026, the latest version of the list.

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.

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#

1. ClinicalTrials.gov, API v2: Phase 3 trials with sites in Romania
2. European Medicines Agency: list of authorised medicines (JSON)
3. Government Decision 720/2008, with its history of consolidated versions
4. Romanian medicines agency (ANMDMR): health technology assessment reports
5. Health Minister’s Order 861/2014: evaluation criteria and scores (consolidated, October 2025)
6. Administrative boundaries (geo-spatial.org, ANCPI)