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EMA To Address Problems With CTIS By Key January Deadline

Online Event On Annual Safety Reports Submitted Via CTIS Coming Soon

 
• By Neena Brizmohun

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.

Clinical trial
The CTIS provides a single portal for clinical trial applications in the EU • Source: Shutterstock

With just weeks to go before it becomes mandatory for sponsors to use the EU’s single-portal Clinical Trial Information System (CTIS) when submitting clinical trial applications, the European Medicines Agency says it is working to solve problems some users have experienced when using the system.

The CTIS will become mandatory on 31 January 2023, a year after it was launched for use on a voluntary...

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