European Health Union: new rules to improve clinical trials in the EU

01/02/2022 87 Views
European Health Union: new rules to improve clinical trials in the EU

As of Monday 31 January,  the assessment and supervision of clinical trials throughout the EU will be harmonised, notably via a Clinical Trials Information System (CTIS) run by the European Medicines Agency. On this date the Regulation on Clinical Trials will enter into application. This Regulation will improve conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.

Welcoming this important step, European Commissioner for Health and Food Safety, Stella Kyriakides, made the following statement:

“The Clinical Trials Regulation marks an important and positive step for European patients and brings us closer to a stronger European Health Union. It will allow us to have swifter authorisation of clinical trials across our Member States, thus improving the efficiency of clinical research as a whole. At the same time, the high quality and safety standards already set for such trials will be upheld. While almost 4000 clinical trials are already carried out each year in the EU, the Regulation will make vital research even more beneficial to the researchers and patients who depend on fast and reliable trials the most.”

The Clinical Trials Regulation aims to ensure a greater level of harmonisation of the rules of conducting clinical trials throughout the EU.

Key features are:

  • streamlined application procedure for all clinical trials conducted in Europe via an online portal (the “Clinical Trials Information System” or CTIS)
  • single authorisation procedure for all clinical trials, to allow a fast and thorough assessment by all concerned EU countries
  • The extension of the silent agreement principle(1) to the authorisation process giving more legal certainty to the organisations or individuals that undertake clinical trials
  • Transparency of clinical trial data will become the rule. Information on the approval, execution and result of a given clinical trial will be available for the general public.
  • Improvement of the collaboration between Member States on the assessment of unexpected events occurring in clinical trials, thus assuring the highest standards of safety for participants in European clinical trials. Ultimately, this will lead to an even better understanding of the benefits and the risks of authorised medicinal products.

Related articles