Highlights from the EMA on changes concerning the submission of paediatric clinical trial information to the European clinical trials database as of 31 January 2023
- As of 31 January 2023 all initial clinical trial applications in the EU/EEA must now be submitted through the Clinical Trials Information System (CTIS), in order to comply with the Clinical Trials Regulation 536/2014,
- Third country files of PIP/Art 46 trials conducted exclusively in third countries are still to be submitted to EudraCT (EudraCT website). Since the implementation of the paediatric regulation 1901/2006, sponsors of trials that are conducted in third countries (outside of the EEA) need to report their trial to EudraCT, in case their trial is part of a Paediatric Investigation Plan, and/or it is conducted under Art. 46 of the paediatric regulation (in essence, if it is linked to a EU paediatric-medicine development).
While until 30 January 2023, the EudraCT database could accept initial CTAs of PIP/Art 46 trials conducted both in the EEA and in third countries, as of 31 January 2023 those trials will need to be reported solely through CTIS. However, if a PIP/Art 46 trial is conducted exclusively outside of the EEA, that trial still needs to be reported through EudraCT, and not through CTIS. Examples: trial conducted in US and in Switzerland that is part of an agreed PIP needs to be reported through EudraCT; trial conducted in US + Switzerland + The Netherlands that is part of a PIP, needs to be reported only in CTIS.
The submission of trial results needs to occur through the EudraCT database, for all trials that are stored in the EudraCT database and that have not been transitioned to CTIS, even after the end of the transition period (30 January 2025).
Additional information on the topic can be found at the bottom of page EudraCT step-by-step guide and in the EudraCT FAQs (questions 98-114).