EU Issues Post-Brexit Clinical Trial Warning
Not All Sponsors Are Ready For January 2021
The UK’s departure from the EU imposes a number of requirements on sponsors running EU trials, but it seems that many have still not taken steps to fall into line.
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A letter addressed to EU leaders has urged them to prioritize the preservation of supply chains and access to medicines for patients in both the UK and the EU as worries grow over the sluggish pace of talks on a trade deal.
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.
An internal memo has revealed the extent of the pharmaceutical industry’s worries over serious product shortages amid the COVID-19 pandemic and the possibility that the UK and the EU will fail to agree a trade deal by the end of 2020.