In brief
New transparency rules related to the Clinical Trials Information System (CTIS), adopted by the Management Board of the European Medicines Agency (EMA) in October 2023, became applicable on 18 June 2024.
Key takeaways
These rules aim at striking a balance between transparency and the protection of commercially confidential information for the benefit of patients, who will have early access to key clinical trial information, of healthcare professionals, who will enjoy simplification in accessing to trial information and enrollment, and of trial sponsors, who will interface with a more user-friendly system.
Among the various changes made to the aforementioned rules, it is to underline the removal of the deferral mechanism, which previously allowed clinical trial sponsors to delay the publication of certain data and documents for up to seven years, starting from the end of the trial, in order to protect personal data and commercially confidential information.
