New rules to improve clinical trials in the EU

As of Monday 31 January, the European Union (EU) will be implementing a new Clinical Trials Information System (CTIS) that is designed to improve trial conducting and participant safety. This event marks one step closer for harmonizing rules across member states in order to make life easier on researchers as well as those who may participate within clinical trials.

Stella Kyriakides, European Commissioner for Health and Food Safety, welcomed this step:

“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.

Over the coming years, the Regulation will create a framework for a more agile clinical trial approval process that will bring Member States closer together in the area of clinical trials. In turn, this will inspire further confidence and trust among citizens, who are at the centre of clinical research. This is why the Regulation is based on the key principle of transparency, allowing for public scrutiny at every step of the way.

I thank the Member States and the stakeholders who all worked closely with us to implement the new regulatory framework for clinical trials in Europe. I am also grateful to the European Medicines Agency, for not only their work on the Regulation, but also for their support in setting up the Clinical Trials Information System that will represent a single entry point for submitting clinical trial information in the EU.”