In line with the Clinical Trial Regulation No 536/2014 an EU Clinical Trial Portal and Database is being developed by the EMA. The Portal will be the single entry point for submitting clinical trial information in the EU, which will be stored in the Database. It enables the supervision of authorised clinical trials by Member States at EU level and provides workspace collaboration tools to assist with this. EMA will make information stored in the database publicly available subject to transparency rules as given in the Clinical Trial Regulation: The EU database “shall be publicly available unless one or more exceptions apply”
These exceptions are:
- to protect personal data;
- to protect commercially confidential information, in particular taking into account the marketing authorisation status of the medicinal product, unless there is an overriding public interest in disclosure;
- to protect confidential communication between Member States in preparing their assessment;
- to protect the supervision of clinical trials by Member States.
- Further details on transparency provisions are provided in the Appendix on disclosure rules to the “Functional specifications for the EU portal and EU database.