EU Guide To Tackle Inconsistent Reporting Of Reference Safety Info In Trials
An EU guideline on the complex subject of how drug sponsors should present and manage the reference safety information in their clinical trial applications is nearing finalization. For the past several months, drug companies have been grappling with an increased regulatory focus on RSI, which has resulted in their trial applications being rejected or studies being significantly delayed.
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The pharmaceutical industry is hoping that changes to the EU guideline on the management and presentation of reference safety information (RSI) in clinical trial applications will help companies struggling with new regulatory focus on this complex subject.
The UK regulatory agency, the MHRA, has identified a range of problems in the way that companies manage clinical trial reference safety information, although views as to what needs to be done to address these issues differ between the regulators and the regulated.
Sponsors of clinical trials in the EU have recently been inundated with objections from regulators for incorrectly managing their clinical trial reference safety information, which in turn has resulted in these trials being significantly delayed. A UK MHRA inspector discusses some of the common issues identified during inspections on this front.