The EU clinical trial portal database
The European Union (EU) clinical trial portal database will support a coordinated approach to clinical trial authorisation and supervision via a single application form for each clinical trial. The European Medicines Agency (EMA) will manage information stored in the database, and will make it publicly available subject to transparency rules.
The clinical trial application form and supporting dossier will cover all regulatory and ethics assessments from the Member States concerned. It will also include the public registration of the clinical trial and any subsequent updates.
The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation comes into operation in 2018. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission.
The goal of Clinical Trial Regulation EU No. 536/2014 is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Regulation will require:
- consistent rules for conducting clinical trials throughout the EU;
- information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.
This will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple Member States. It aims to foster innovation and research, while helping avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.
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 authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation.
The authorisation and oversight of clinical trials remains the responsibility of Member States, with EMA managing the database and supervising content publication on the public website