EU Clinical Trials Regulation To Apply From December 2021
New EMA Boss To Be Elected On 25 June
Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi.
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The European Medicines Agency’s management board has agreed a revised go-live date for the new clinical trial information system. The new date is 'aspirational' and might change again depending on how the system fares in an ongoing independent audit to ascertain its full functionality.
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.
An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.