Regulation (EU) No 536/20141 61 (hereinafter ‘the Clinical Trials Regulation’ or ‘the Regulation’) repeals Directive 2001/20/EC on Clinical Trials and establishes a harmonised approach to the submission, assessment and reporting of clinical trials (CTs) information with the implementation of consistent rules throughout the European Union (EU)/European Economic Area (EEA) Member States (MSs).
The Regulation aims to foster innovation through simplification of the clinical trial application process, and to increase transparency and availability of information on clinical trials and their results.
In accordance with Recitals 66 and 67 and Articles 80 and 81 of the Clinical Trials Regulation, the Agency, in collaboration with the Member States and the European Commission (EC), has the obligation to set up and maintain a EU Portal as a single entry point for the submission of data and documents relating to clinical trials and a EU Database containing the data and documents submitted 1 via the EU Portal in accordance with the Regulation. The EU Clinical Trials Portal and Database are
jointly referred to as the EU Portal and Database (EUPD).
The EU Database should contain all relevant information as regards the clinical trials submitted through the EU Portal. To ensure transparency of clinical trials, the EU Database should be publicly accessible and data should be presented in an easily searchable format.
The EUPD is a key instrument to ensure transparency of clinical trial information. The database serves as the source of public information on assessed clinical trial applications, clinical trials conducted from the time of decision, authorisation and finalisation and their results.
The EUPD and associated workspaces provide MSs, the European Commission, the Agency, sponsors and applicants to a marketing authorisation with an effective network to streamline and facilitate the preparation of the flow of information for the authorisation and supervision of clinical trials in the EU.
The EUPD, that enables the submission and storing of clinical trial information, is one of the two components of the Clinical Trial Information System (CTIS). More specifically, the CTIS encompasses a:
• Clinical Trial module consisting of the EUPD, which includes the:
− Secure domains accessible to Authorities and Sponsors users for the submission of clinical trial applications and trial information during its life cycle, and
− Public website, which is accessible to the public.
• Safety module of EudraVigilance (EV) consisting of the:
− Repository of Annual Safety Reports (ASRs) in accordance with Article 43 of the CTR for the submission of ASRs in aggregated and anonymised format containing safety information for the investigational medicinal products (IMPs) used during the trial.