EMA’s Management Board met on 5 October in Amsterdam.
Clinical trials in the EU
The Board adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The revision focuses on the early publication of clinical trial data and documents that are most relevant for the public, including patients and the researcher community. More details about the revised transparency rules are available in a news announcement published on EMA’s corporate website.
Support for the implementation of the Clinical Trials Regulation (CTR) remains a priority. EMA presented the operational experience and recent improvements implemented in CTIS. The monthly number of submissions of clinical trials through CTIS continues to increase. By the end of August 2023, over 2000 initial applications have been submitted through CTIS, since launch of the system at the end of January 2022. The Board welcomed EMA’s continued efforts to support stakeholders via workshops, trainings and regular communications…
