BILLEV PHARMA EAST

NEWS

20 June 2024

Launch of New CTIS Public Portal

New version of the CTIS public portal was launched on 18th of June 2024 by EMA. Additionally, the new ACT EU – User guide provides a summary of the revised CTIS transparency rules.

 

The updated rules achieve a balance between information transparency and Commercially Confidential Information (CCI) protection. Patients benefit from them since important clinical trial data that they identified as being most relevant to them is released ahead of schedule. They additionally provide information about process simplifications that help sponsors of clinical trials that are obliged to preserve personal and commercially sensitive data.

 

The elimination of the deferral mechanism, which permitted sponsors to postpone publishing some data and documentation for up to seven years following the conclusion of the trial in order to preserve commercially sensitive material, is one of the main modifications made to the new regulations.

 

There will be a significant rise in the total number of trials that are made available to the public. The public will also have access to clinical trials that CTIS received before the new transparency rules were implemented.