Irish Medical Times Medical News for Healthcare Professionals
By Gary Culliton. EU Health Commissioner Tonio Borg has welcomed a vote in the European Parliament on the Clinical Trials Regulation, which could save up to €800 million per year in regulatory costs.
Commenting on the Parliament’s backing of the revised rules for clinical trials, Borg said: “This endorsement brings us one step closer to ensuring an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States.
“Intrinsic to this is the simplification of current rules, featuring a ‘one-stop’ portal and database for submitting applications, a quick and flexible assessment procedure, a simplified reporting system and clearer, simpler rules for running multinational trials.”
Clinical trials are crucial for patients affected by serious or rare diseases, as often they are the only way for them to have access to the most advanced, life-saving treatments, the Commissioner said. Moreover, taken together, the new measures should save research institutions and companies conducting clinical trials in the EU €800 million per year in regulatory costs — removing the most significant barrier to keeping clinical research within EU borders.
With in excess of €20 billion spent annually in the region on pharmaceutical innovation and health-related research and development, it was “vital for the EU economy that we remain major players in this booming sector”, added Borg. “I am convinced that the new rules will ensure a big boost for research and development in the EU for the benefit of patients, and contribute to the Europe 2020 objectives of smart, sustainable growth.” He added that the latest move would enable the regulation to enter into force in coming months.
gary.culliton@imt.ie
