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UK MHRA: ‘At Least Half’ Of Novel Drug Filings To Take National Assessment Route

 
• By Ian Schofield

With approval applications for new active substances expected to rise by 25% by 2026, the UK regulator says it wants to focus its national assessment procedure on new innovative therapies. It will also review progress with the new International Recognition Procedure.

Innovation light bulb
The MHRA is expecting a rise in filings for innovative drugs (Shutterstock)

The UK Medicines and Healthcare products Regulatory Agency says it wants at least 50% of its future evaluations of new innovative therapies for marketing authorization to be conducted under its national assessment route, with other applications going through the new International Recognition Procedure (IRP).

It also intends to review the IRP to make sure it is working as intended and that there is “ongoing adherence to statutory timelines” by the third quarter of the...

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