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EU Finalizes Rules For Coordinated Trial Safety Assessment Under CTR

 
• By Vibha Sharma

A new implementing regulation provides a legal basis for EU member states to cooperate on the assessment of trial-related safety reports linked to an active substance instead of the investigational medicinal product. 

Clinical trial
EU Is Strengthening The Safety Oversight Of Clinical Trials • Source: Alamy

The European Commission has published new rules explaining how EU member states should coordinate and cooperate with each other to assess the safety of studies under the EU Clinical Trial Regulation when it comes into force on 31 January.

The rules and procedures for the coordinated safety assessment of clinical trials are specified in a new implementing regulation...

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