Fiaso-Farmindustria accelerates the approval process for clinical trials: a breakthrough in medicine
Italy is making strides in speeding up the approval of clinical trials. This is the request that emerged from a meeting between the Italian Federation of Health and Hospital Companies (Fiaso) and Farmindustria, which took place today at the “G. Bonadonna” Auditorium of the IRCCS National Cancer Institute in Milan.
In 2022, clinical trials in Italy returned to pre-pandemic levels, with 713 trials focused primarily on phases II and III, placing Italy third in the European Union in terms of the number of clinical trials conducted, following Spain and Germany. In the same year, investments in research and development amounted to 1.9 billion euros, accounting for 6.8% of the total investments in Italy.
Despite the European Regulation for Clinical Research establishing aligned authorization times for all member countries (ranging from a minimum of 60 days to a maximum of 106 from the submission date), administrative approval processes in Italy are longer and more cumbersome compared to the European average, as highlighted by the two organizations.
“Clinical research not only represents an opportunity for innovation but is also crucial for improving the appropriateness of care offered to patients and contributing to the sustainability of the healthcare system. Fully integrating clinical research into business strategies is essential to ensure efficient use of resources,” emphasizes Giovanni Migliore, President of Fiaso. “Therefore, it is necessary to quickly complete the regulatory framework to enable national healthcare centers to attract new investments and remain competitive internationally.”
“For our nation, it is essential to ensure citizens faster access to innovation, with a more modern approach that we hope will come from the reform of Aifa,” adds Farmindustria President Marcello Cattani. “Because these timelines, combined with those necessary for arrival in individual regions, are too long for patients who have the right to be treated as soon as the therapy is available,” he concludes.
The collaboration between Fiaso and Farmindustria aims to streamline the approval process for clinical trials in Italy, ensuring that patients have faster access to innovative treatments. By reducing administrative hurdles and aligning with European standards, Italy can attract more investment in research and development, fostering competitiveness and contributing to the advancement of medical science.
The importance of clinical research cannot be overstated. It not only drives innovation but also plays a vital role in improving patient care and ultimately the sustainability of the healthcare system. By integrating clinical research into their strategies, healthcare companies can ensure the efficient use of resources and provide patients with the most effective treatments available.
Italy’s commitment to accelerating the approval process for clinical trials is a significant step forward. The country’s achievements in 2022, with a notable increase in the number of trials conducted, demonstrate its dedication to advancing medical science and providing better care for its citizens.
Efforts to reform Aifa, the Italian Medicines Agency, are crucial in modernizing the approach to approvals and ensuring that patients receive timely access to innovative therapies. By streamlining processes and reducing unnecessary delays, Italy can meet the needs of patients and maintain its competitiveness on an international level.
The collaboration between Fiaso and Farmindustria is a positive development that will benefit both patients and the healthcare industry as a whole. By working together to overcome administrative obstacles and improve efficiency, Italy can continue to attract investments in research and development, ultimately contributing to the advancement of medicine.
In conclusion, Italy’s commitment to accelerating the approval process for clinical trials is a welcome breakthrough in the field of medicine. By streamlining procedures and reducing unnecessary delays, the country is paving the way for faster access to innovative treatments, benefiting both patients and the healthcare industry. Through collaboration and a modernized approach, Italy can remain competitive on the global stage and continue to drive advancements in medical research.