The long awaited EU Clinical Trials Regulation applies from today, 31 January 2022.
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EU Clinical Trials Regulation: The Clinical Trials Information System expected to go live by December 2021, according to the EMA
Posted in Clinical Trials Regulation, EMA
On 11 June 2020, the European Medicines Agency (EMA), during its Management Board meeting, has endorsed the methodology and next steps leading to the go-live of the Clinical Trials Information System (CTIS) which is now fixed for December 2021. A group consisting of representatives of the EU Member States and the European Commission has been set up to prioritise and coordinate all outstanding issues prior to go-live. The CTIS is the centralised EU portal and database for information storage foreseen by the Clinical Trials Regulation.
Continue Reading EU Clinical Trials Regulation: The Clinical Trials Information System expected to go live by December 2021, according to the EMA