New clinical trial system to soon become mandatory in Europe
The European Medicines Agency sought to remind industry today that use of the new Clinical Trials Information System (CTIS) will be mandatory for all new applications as of Tuesday, Jan. 31.
Following a one-year, optional transition period where sponsors could still submit under the Clinical Trials Directive, the CTIS will soon serve as the single entry point for submissions and for regulatory assessments, and all filings will have to come under the Clinical Trials Regulation, EMA said.
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