10/11 October 2023
As previously reported about the update of the EMA timelines for portal and database, the initial application of the new Clinical Trial Regulation (CTR) will most likely be postponed to the year 2020. The European Medicines Agency (EMA) has now published an estimated roadmap for their important IT projects. In the form of the so-called "Extended EU Telematics strategy and implementation roadmap 2018-2019", the EMA has set out the implementation of important IT projects within their area of responsibility for the next two to three years. This includes the initial application of the EU portal for clinical studies and the corresponding database. So far, the application had been scheduled for the second half of the year 2019, the roadmap now shows, however, that the initial application will take place in 2020, at the earliest.
With respect to the dates laid down in the roadmap, the EMA also points out that the scheduled move to Amsterdam in the first quarter of 2019 will have a substantial effect on the respective projects so that the mentioned timeline might be postponed further.
The initial application of the EU CTR and all related regulations and guidelines depends on the first application of the database and portal. This affects, inter alia, also the changes to Annex 13 of the EU GMP Guidelines and the Template for QP IMP Release.