MHRA pilot seeks evidence of patient involvement in R&D


25 March 2021 - The UK MHRA has begun a pilot project to encourage patient involvement in drug development, asking companies that seek approval for new active substances and new indications to provide evidence of “patient involvement activities they undertook when developing their product.”

For now, the project is focused on gathering information. Applicants can choose whether to provide MHRA with the requested information, which for now will have no effect on the outcomes of submissions. MHRA wants to better understand the roles patients are playing in drug development currently so it can work with other stakeholders to shape their involvement in the future.

Read Regulatory Affairs Professional Society article

Michael Wonder

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Michael Wonder