EU Explains Safety Reporting Under New Clinical Trial Regs

 
• By Ian Schofield
  
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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.

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The EU has updated draft guidance on clinical trial safety reporting • Source: Shutterstock

In the latest stage of the very lengthy process of implementing the EU Clinical Trials Regulation, the European Commission has issued updated draft guidance that includes new information on trial safety reporting requirements. Among issues covered are the use of reference safety information, the reporting of suspected serious adverse reactions, and submission of the annual safety report.

The new section on safety reporting has been drawn up by the Clinical Trials Facilitation and Coordination Group of Europe's...

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