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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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.
The EMA explains how sponsors can comply with transparency requirements under the EU Clinical Trial Regulation while protecting personal data and commercially confidential information.
In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.