Clinical Trials

Developing a competitive model for clinical trials in Romania.

This project is carried out under the strategic coordination of the National Agency for Medicines and Medical Devices of Romania (ANMDMR). Its goal is to increase Romania’s clinical trial capacity in the medium term, beginning with assessing the 2023 status.

National Context

Romania has significant potential to host clinical trials, meeting many of the necessary conditions to attract them, as outlined in the 2020 IQVIA study “Development of the Clinical Trials Market in Romania.”

Compared to smaller countries like Bulgaria and Hungary, Romania lags behind in the number of clinical trials conducted. Prior to recent legislative reforms, Romania was classified as “significantly underdeveloped” in this field.

Romania benefits from a large population and a relatively efficient patient recruitment process.

There is a substantial number of patients with non-communicable diseases.

The quality of collected data is comparable to that of neighboring countries, with best-practice standards in line with EU norms.

Costs remain competitive, and investigators are well-trained and qualified, based on education, training, and experience as of 2019.

The local regulatory framework is fully compliant with European Union (EU) regulations.

Romania has the opportunity to increase the number of studies conducted at the regional level if it chooses to invest in this pillar of research and innovation.

The legislative framework for approving clinical trials in Romania has been significantly improved, thereby creating the right context to maximize the country’s potential to attract and conduct clinical studies.

There is an alignment of key stakeholders that can quickly transform the topic of clinical trials into a strategic pillar of Romania’s economic competitiveness and access model, with significant socio-economic impact.

Workshop HUB

Project objectives

Developing a medium-term strategic plan to increase Romania’s capacity in the field of clinical trials, endorsed by the relevant stakeholders.

Increasing public awareness and improving patient and physician access to information about clinical trials conducted in Romania.

Increasing the capacity of the academic environment to participate in clinical trials.

The socio-economic impact of developing Romania’s capacity to conduct clinical trials is significant.

Increasing the number of clinical trials conducted in Romania primarily brings major benefits to patients, who will gain access to the latest treatments and specialized medical services, which can lead to improved survival or quality of life. 

The healthcare system benefits through the retention of medical personnel and the reduction of investigation costs during clinical trials./span>

For investigators, conducting clinical trials provides opportunities for professional development and recognition, as well as knowledge transfer.

Clinical trials represent foreign investments in Romania and make significant contributions to the state budget, serving as a source of revenue with growth potential. The clinical trials market in Romania is valued at €72 million (2019 data, IQVIA) and has the potential to reach €802 million, or even €1.4 billion, when compared with the best-performing countries in the EU.

Given these premises, the Health Innovation Hub, under the strategic coordination of ANMDMR, is developing the National Strategic Plan for the Development of Clinical Trials in Romania. The plan’s objective is to position Romania as one of the key regional players in conducting clinical trials. The implementation and monitoring of the strategy will be based on performance indicators aligned with the project’s purpose and will involve all relevant stakeholders.