EMA To Address Problems With CTIS By Key January Deadline
Online Event On Annual Safety Reports Submitted Via CTIS Coming Soon
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.
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The release process for investigational medicinal products, shipping and contractual arrangements are among the topics discussed in guidance that came into effect on 1 January.
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.
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.