EU Finalizes Rules For Coordinated Trial Safety Assessment Under CTR
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.
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When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.
An updated guidance document on the EU Clinical Trials Regulation has been published, with new information regarding the requirements for reporting safety issues in clinical trials. The European Medicines Agency says progress with developing the new clinical trial information system is going well but some more enhancements are needed.
EU regulators are increasingly raising objections over the reference safety information that companies include in their clinical trial applications and updated investigator's brochures.