EMA Offers Weekly Updates On Getting Clinical Trial Portal Ready For Mandatory Use
Agency Says No Blocking Technical Issues In Core CTIS Processes By Legal Deadline
The European Medicines Agency’s management board is keeping a close tab on ongoing efforts to ensure that the Clinical Trial Information System is stable enough to support its mandatory use by study sponsors from 31 January 2023.
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EMA Confirms CTIS Ready For Mandatory Use By 31 January Deadline
The European Medicines Agency says that over 80% of the blocking issues and related workarounds affecting the Clinical Trials Information System have been resolved.
Mandatory Use Of ‘Dysfunctional’ EU Clinical Trial Portal Raises Concern In Germany
Efforts are on to address the “serious deficiencies” raised by the German associations for medical ethics committees, trial sponsors, contract research organizations and other stakeholders regarding the EU Clinical Trial Information System that will become mandatory from 31 January 2023.
EMA To Address Problems With CTIS By Key January Deadline
The EU’s single-portal Clinical Trial Information System will become mandatory from 31 January 2023 for sponsors seeking clinical trial approval. Problems that some users have experienced while using the system voluntarily are being fixed, according to the European Medicines Agency.