Initially the EU Clinical Trial portal and database was due to be launched in 2018 but technical difficulties with developing the complex IT systems mean that this will be postponed until 2019.
The introduction of the EU Clinical Trials portal and database is fundamental to the Clinical Trial Regulation, which was adopted and entered into force in 2014. The Regulation set out to harmonise the electronic submission and assessment process for clinical trials conducted in the EU, by using a single EU-wide portal and database.
The portal and database system has three main purposes:
- to provide a single point for sponsors to submit clinical trial information in the EU, before during and after the trial;
- to allow coordinated assessment and supervision of trials by the Regulatory Authorities and Ethics Committees;
- to provide public access to a database of information on all clinical trials conducted in the EU.
Once the IT systems have been developed, tested and independently audited, the European Commission will issue ‘confirmation of full functionality’. The Regulation will be formally applied six months later and this is expected to be in 2019.
If you need support with your Clinical Trial application in the meantime, please contact the Regulis team and we will be happy to assist.