Completion EU clinical trial portal postponed to 2019
The European web portal and the European database for clinical trials will be completed in 2019 instead of October 2018, as previously scheduled. This was decided by the European Medicines Agency (EMA). The reason for the postponement is a delay in the development of the software for the portal and the database.
The web portal and the database are under development for the implementation of EU Clinical Trial Regulation 536/2014. The postponement means that the new European legislation on clinical trials will also become effective in 2019.
The EMA management board will discuss progress of the development of the web portal and the database in October 2017. Following this, the EMA management board will discuss a new time frame and possibly announce the new date of completion.
The CCMO is investigating if the delay has implications for the ongoing activities that the CCMO has initiated to prepare the Netherlands for the new European legislation on clinical trials.