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Innovating to help patients with life-threatening conditions

Last updated on 28 Apr 2022

We’ve been working with the Medicines and Healthcare products Regulatory Agency (MHRA) on guidance for the Early Access to Medicine Scheme, which is now supported by new regulations.

The scheme supports innovation by allowing patients with life-threatening or seriously debilitating conditions, and without existing treatment options, to use new medicines before they get a marketing authorisation. The scheme relies on collecting ‘real world data’ from patients.
The new guidance clarifies that collecting data through the scheme must not be for the purpose of research. This means it does not need clinical trial authorisation or ethics review. However, the data that is collected may have research value once collected.
Find out more on our website.

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