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UK Offers 14-Day Approvals For Lowest-Risk Phase III/IV Trials

 
• By Vibha Sharma

The Medicines and Healthcare products Regulatory Agency says it is in “everyone’s best interest” if clinical trial sponsors seeking UK approval for low-risk Phase III and IV studies make use of its new notification scheme that will cut the 30-day statutory evaluation timeline by more than half.

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UK Is Taking A Risk-Proportionate Approach To Processing Initial Clinical Trial Applications • Source: Shutterstock

The UK has formally kick-started the overhaul of its clinical trials framework with the launch of a new notification scheme under which the regulatory evaluation timelines of the lowest-risk studies, for example some Phase III trials already authorized in the US or the EU, will be reduced by more than 50%.

The notification scheme is open to applications for initial Phase III and IV trials meeting certain criteria. Applications accepted into the scheme will be processed by the Medicines and Healthcare products Regulatory Agency within 14 days instead of the current statutory 30 days

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