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EMA – Revision of the CTIS transparency rules

EMA has revised its transparency rules for publishing information on clinical trials submitted through CTIS.

The revised rules enable easier access to clinical trial information, and ensure a balance between transparency and protection of commercially confidential information. These changes benefit patients, healthcare professionals and clinical trial sponsors.

The revised rules will apply once they have been implemented in CTIS, which is expected in the second quarter of 2024. The appendix on disclosure rules continues to apply until the revised rules are implemented.

More information on the CTIS development and transparency requirements on the EMA website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (12 mars 2024). EMA – Revision of the CTIS transparency rules. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/w050


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