# National Agency for Medicines and Medical Devices of Romania (ANMDMR)

Source: https://onco.cc/institutions/anmdmr/  
OnCo record `anmdmr` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

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.

## Fields

- Kind: Institution
- Last checked: 2026-11-04
- Also known as: Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România; ANMDMR; ANM Romania
- City: Bucharest, RO
- Type: government
- Website: https://www.anm.ro

## Sources

- ANMDMR: evaluare tehnologii medicale: https://www.anm.ro/medicamente-de-uz-uman/evaluare-tehnologii-medicale/
- Ordinul MS nr. 861/2014, consolidated to July 2020, articles 6 to 8 and annexes 1, 2 and 5 (PDF): https://www.anm.ro/_/EVALUARE%20TEHNOLOGII%20MEDICALE/ORDIN%20Nr.%20861%20din%2023%20iulie%202014.pdf
- OECD/EC, Country Cancer Profile Romania 2025, section 5.1 (PDF, Internet Archive copy): 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

## Connected records

- institutions: [European Medicines Agency](https://onco.cc/institutions/ema/), [National Health Insurance House of Romania (Casa Națională de Asigurări de Sănătate)](https://onco.cc/institutions/cnas-romania/)

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