UK MHRA pilots patient involvement in new applications

Today the MHRA has announced a new pilot, which will request, on a voluntary basis, applicant companies of new active substances and new indications to provide evidence of the patient involvement activities they undertook when developing their product.
For clinical trials, additional information won’t be requested at this early exploratory stage but the MHRA will be documenting in medical assessment reports if there is evidence of patient involvement in clinical trial applications in order to better understand the current scope of activities. The MHRA hopes to use this as a learning exercise on how to integrate patient involvement into the approvals process from “any-patient related activities that take place during development” and also use this knowledge to improve the quality of clinical drug development and health outcomes in the future.

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