Highlights from the EMA on changes concerning the submission of paediatric clinical trial information to the European clinical trials database

Clinical Trials Pediatric submissions

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

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).

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Many thanks for your understanding.

The PharmaLex Team