17/18 March 2021
According to the EMA (European Medicines Agency), the aim of the new Clinical Trial Regulation EU No. 536/2014 is "to create an environment that is favorable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information."
The Regulation will therefore require:
The expected benefits will be:
When the Regulation becomes applicable, it will replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive. It will also apply to trials authorized under the previous legislation if they are still ongoing three years after the Regulation has come into operation.
Although the Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the EU portal and database. The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation. EMA's Management Board endorsed a previously published delivery timeframe, which foresees October 2018 as application date. However, EMA states that "due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed." Maybe this is also connected to the imminent Brexit and its possible impact on EMA´s future location.
EMA says that its "Management Board will discuss a new delivery time frame in October 2017 once the developer confirms progress." Due to these delays, it is now expected that the EU Clinical Trial Regulation will come into application during 2019 instead of in October 2018, as previously scheduled.
For more information on this and on the original delivery timeframe please visit the EMA Clinical Trial Regulation website.