Patients can gain access to cutting-edge medicines before they are officially approved, announced Dr. Pharm. Răzvan Prisada, President of the National Agency for Medicines and Medical Devices of Romania (ANMDMR), during the launch event of the Health Innovation Hub. According to him, by using legislative innovation tools, more than 200 clinical trials were authorized in Romania between August 2022 and the end of January 2023, creating the context for transforming the country into a regional hub for clinical research.
The Health Innovation Hub has three strategic directions, with the Agency you lead playing an essential role as the scientific coordinator of the Clinical Trials strategic direction. What steps will be taken to develop this segment?
Through the Health Innovation Hub, we have the opportunity to bring together all relevant stakeholders to develop a competitive model for clinical research in Romania, with a major positive impact on patients, the medical community, and the healthcare system as a whole.
To achieve this goal, we plan to conduct an analysis of the current situation and to formulate short-, medium-, and long-term action directions. We need the parameters of a concrete national action plan, with annual and multi-annual performance indicators, to be implemented over the next three years, with the possibility of extending it to five years, which we will agree upon and commit to. External partnerships with relevant stakeholders in the field are essential.
What are the benefits of such a competitive model in the field of clinical trials?
Patients will have access to cutting-edge medications before they are officially authorized. Medical professionals, including healthcare facilities, will gain access to new technologies, medical equipment, and innovative treatment protocols. When it comes to healthcare facilities, my goal through this Hub is to create an integrated framework that will allow universities to develop university hospitals where these activities can be carried out.
Naturally, there will also be benefits for the pharmaceutical industry: companies will be able to conduct clinical trials in Romania with shorter enrollment timelines, given that authorization is now issued within 30–60 days, thanks to the amendments to Romania’s clinical trials legislation made in mid-2022.
What are the overall needs of the healthcare system when it comes to clinical trials?
First and foremost, we need the industry to once again see Romania as a country that deserves to be placed back on the map of clinical trials. We need well-trained medical teams and patients, but adjustments are necessary to make patient enrollment in clinical trials more efficient.
A first step has already been taken: we have reached out to patients and the medical press to explain, in accessible language, what clinical trials are, what their real benefits are, and how this field represents the gateway for bringing innovation into Romania. We also need integrated centers belonging to universities, where we can initiate these projects and attract the necessary funding.
All of these aspects will be included in the action plan, as we are fully aware—within this partnership—that clinical trials are a driving force of technological progress.
Valentina Grigore
