Asset Publisher

null International Clinical Trials Day on 20 May 2022 introduces the EU's regulatory reforms

International Clinical Trials Day on 20 May 2022 introduces the EU's regulatory reforms

20.5.2022

The European Medicines Agency (EMA) showcases the new EU Clinical Trials Regulation and the Clinical Trials Information System (CTIS) introduced at the beginning of 2022 at the International Clinical Trials Day on 20 May 2022. After the transition period, all clinical trial applications are submitted through CTIS by 2025.

So far, three trials have been sent to Fimea for assessment through CTIS. The assessment is carried out in coordination with the National Committee on Medical Research Ethics (Tukija) and the pharmaceutical agencies of the member states involved in the trials.

Watch a new video that describes the conduct and assessment of clinical trials in the EU with the new EU regulation and database. The video is produced by EMA.

Clinical Trials in the EU (Youtube) 

International Clinical Trials Day on the 20th of May is the day when the results, sponsors, investigators and significance of clinical trials are in the spotlight. The date for the celebration was chosen after the date James Lind started his scurvy trial, which is considered to be the first modern clinical trial, aboard a ship on 20 May 1747. International Clinical Trials Day has been celebrated since 2005 at the initiative of ECRIN.

Supervision of clinical trials on Fimea's website

Clinical trials in the European Union

ECRIN: International Clinical Trials Day (ICTD)

Further information

clinicaltrials@fimea.fi