Transparency Provisions In EU Clinical Trial Portal To Be Reviewed In 2023
Public Consultation Expected In Q1 Next Year, Says EMA
The European Medicines Agency’s management board believes it is time to review the disclosure rules under the EU Clinical Trial Regulation that were agreed almost seven years ago.
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Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal
An analysis of publicly available information in the EU Clinical Trials Information System shows how commercial and academic sponsors differ in their approach to transparency. There are also concerns around the lack of “push back” from EU member states to address potential non-compliance.
More Work Needed To Support Transparency Under Clinical Trials Regulation, Says EFPIA
Research-based drug companies believe the EU guideline on protecting confidential business and personal information in the clinical trials portal CTIS addresses some key concepts, but they point to the need for greater clarity and simplification going forward.
New Guidance To Clarify Transparency Provisions In EU Clinical Trials Portal
EU regulators have developed new guidance to help companies steer through the transparency requirements in the Clinical Trials Information System and protect personal and commercially confidential information in submissions.