EU Clinical Trial Portal and EU Database Declared Functional by European Commission - EU Clinical Trials Regulation to Take Effect on 31 January 2022

• 09/08/2021
• Articles

On 31 July 2021, the EU Official Journal published Commission Decision (EU) 2021/1240 of 13 July 2021 “on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council” (the Decision; see, attached copy).
 
In line with Article 82(3) of the EU Clinical Trials Regulation (i.e., Regulation (EU) No 536/2014 of 16 April 2014; the CTR), the Decision confirms that “[t]he EU portal and the EU database have achieved full functionality and meet the functional specifications”.  As a result of this confirmation, the CTR will take effect on 31 January 2022, as was the shared desire of the European Medicines Agency (EMA) and its Board and of the European Commission (see, Van Bael & Bellis Life Sciences News and Insights of 22 April 2021).
 
While the CTR will repeal and replace the current Clinical Trials Directive (i.e., Directive 2001/20/EC – the CTD) as from 31 January 2022, clinical trials for which the request for authorisation is submitted before 31 January 2022 will continue to be governed by the CTD until 31 January 2025 (Article 98(1) of the CTR).  Furthermore, clinical trials for which the request for authorisation will be submitted during the first year of application of the CTR (i.e., between 31 January 2022 and 31 January 2023) can still be started in accordance with Articles 6, 7 and 9 of the CTD, in which case the CTD will continue to apply until 31 January 2025 (Article 98(2) of the CTR).
 
On 29 July 2021, EMA published a “Sponsor Handbook” to assist clinical trial sponsors in getting ready for use of the Clinical Trial Information System (CTIS) as foreseen by the CTR (see, attached copy).  CTIS contains the centralised EU Portal and EU Database.  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 will be made publicly available subject to limited exceptions.
 
On the same date, EMA also released guidance on the data fields that clinical trial sponsors will need to complete in CTIS when submitting a clinical trial application or managing a clinical trial (available here).  Additional guidance will be made available later this year.