Health Innovation Hub: Launch of the Strategic Plan for the Development of Clinical Trials in Romania

“The Health Innovation Hub is a project that has achieved notable progress just one year after its launch. In 2019, Romania ranked among the last in the European Union in terms of clinical trials; however, positive developments are already visible and are now complemented by this strategic plan for clinical trials. Patient access to innovative therapies, including through these clinical trials, offers hope for improved health or even recovery. In addition, we have two major objectives aimed at encouraging research, development, and investment in the pharmaceutical industry. A strategic vision also involves fostering the pharmaceutical sector—elements that we will address through a working group established together with the Ministry of Economy and representatives of the pharmaceutical industry.”
— Prof. Dr. Alexandru Rafila, Minister of Health

It is crucial to recognize the importance of increasing the number of clinical trials conducted in our country. This reflects not only a positive signal about Romania’s potential, but also a firm commitment to progress in the medical and pharmaceutical fields. Clinical trials are vital not only for patients—offering access to the newest treatments—but also for contributing significantly to the national economy. Romania has enormous potential, built on the quality of its personnel and the education in Romanian medicine. These resources are invaluable and can contribute greatly to the success of clinical trials and the advancement of medical science. Therefore, I strongly support the need for a well-defined strategic plan to guide our efforts in achieving ambitious goals.”
— Assoc. Prof. Dr. Diana Păun, Presidential Adviser, Department of Public Health

“The strategic plan’s objective of positioning Romania as one of the key regional players in the field of clinical trials is supported by the G6-UMF University Alliance. By implementing this national plan, Romania can climb the clinical trials map, benefiting from numerous factors that support the development of this field, such as the involvement of academia, the launch of the first master’s program in clinical trials, and the outstanding quality of its investigators. This is a cornerstone project of the Health Innovation Hub, progressing at an accelerated pace, and one in which we will continue to be actively involved.”
— Prof. Dr. Viorel Jinga, Rector of UMFCD and President of the G6-UMF University Alliance

“With the launch of this Plan, we are also marking one year since the establishment of the Health Innovation Hub—a national project of major importance for Romania’s healthcare sector—and two years since we made clinical trials a priority area. The results are already beginning to show, with our country becoming increasingly competitive in the clinical trials market. I assure you that ANMDMR, as the national authority for human medicines, a founding member of the Health Innovation Hub, and coordinator of the Strategic Plan for the development of clinical trials, will focus its efforts in the coming period both on including this plan in the ANMDMR Strategy 2024–2026 and on monitoring its implementation, as well as on informing and educating patients and all stakeholders about clinical trials.”
— Dr. Răzvan Prisada, President of ANMDMR

“Romania has a number of advantages that support the goal of increasing the number of clinical trials. First, the management and conduct of clinical trials in Romania are of very high quality, recognized by international organizations. Second, the expertise of the personnel involved in clinical trials is extensive, built over years of medical practice. In addition, the existence of a master’s program dedicated to clinical trials and collaboration with patient associations is another significant advantage. Of course, one of the most important opportunities is the new clinical trial approval procedure, which makes us competitive with other countries at both the European and global levels.”
— Prof. Dr. Dragoș Vinereanu, President of the Senate, UMFCD

“The long-term goal is to help create a modern healthcare system, open to innovation, that allows us to reach European standards. The Health Innovation Hub works in alignment with Romania’s health strategy. It is important to move the discussion toward prioritizing the healthcare sector and the pharmaceutical sector, which can become a strategic segment and contribute to increasing Romania’s economic competitiveness. We must attract investments and truly put them at the service of patients on a much larger scale, including through the development of the clinical trials sector. The strategic plan for clinical trials is an especially important step, developed with the support of all stakeholders involved in this field.”
— Radu Rășinar, President of the Local American Working Group, representing 14 international companies investing in the research and development of new treatments

“Implementing a competitive model for clinical trials in Romania, based on the efforts of the Ministry of Health and the National Agency for Medicines, connects Romania to international medical research and increases patient access to innovative treatments. This will also bring additional benefits in attracting foreign investment, retaining medical personnel, promoting technology transfer, and increasing state budget revenues. As a next step, it is essential to improve access to medical innovations so that all patients can benefit from advances in healthcare.”
— Frank Loeffler, Vice President of the Local American Working Group