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UK Regulator Wants More Patient Input At Pre-Authorization Stage

 
• By Ian Schofield

The MHRA is taking steps to embed “meaningful and impactful” patient involvement across its regulatory pathways.

Patient group
The MHRA wants more input from patients (Shutterstock)

The UK medicines agency, the MHRA, says it is planning to increase the role of patients in its scientific assessments by boosting their input at the pre-authorization stage, possibly in cases such as the submission of a new active substance, a new indication of an existing drug, or a combination product.

It is also proposing to boost patient input in cases where more information is needed, such as assessments for conditional marketing authorization or where patient views would help to determine...

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