EMA reports that the point in time when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into force has been delayed from October 2018 to 2019. The decision was taken at EMA’s board meeting on 15 June.
The reason for the delayed time plan is late delivery from the IT supplier developing the portal/database that constitutes the hub for future handling of medicine trials. The exact time when the regulation will come into force will be determined at the EMA’s board meeting in October 2017.
Further information on the decision (in Swedish)
Office for Clinical Studies
Östra Hamngatan 26
SE-411 09 Göteborg
Phone: +46 (0)31 757 41 75
Would you like to subscribe to news, good examples or calendar events from clinicalstudies.se?