EU Clinical Trial Portal and EU Database Declared Functional by EMA Board - EU Clinical Trials Regulation Expected to Take Effect on 31 January 2022
- 22/04/2021
- Articles
Yesterday, the European Medicines Agency’s Management Board (the EMA Board) confirmed that an independent audit by KPMG has found that the EU Clinical Trial Portal and EU Database are fully functional (see, attached press release). This confirmation, which has been delayed for years due to technical difficulties with the development of the Portal’s and Database’s underlying IT systems, finally paves the way for the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR) to take effect on 31 January 2022. The CTR was initially scheduled to become operational in October 2018.
In line with Article 82 CTR, the EMA Board will inform the European Commission (the Commission) of its findings. Provided the Commission is satisfied that the EU portal and the EU database are fully functional and meet all functional specifications, it will publish a notice to that effect in the EU Official Journal. The CTR will take effect six months after the publication of the notice (Article 99 CTR). Accordingly, for the CTR to go live by 31 January 2022, as seems to be the shared desire of the EMA Board, EMA and the Commission, the notice should be published on 31 July 2021.
Once operational, the EU portal will serve as the single entry point for the submission of clinical trial applications, clinical trial-related information and for all communications by and between clinical trial sponsors and Member State authorities. The EU Database will store all data and information submitted through the EU Portal and, subject to limited exceptions, will be made publicly available.
