Please note this is an extract of the original bulletin.
Consultation on proposals for legislative changes for clinical trials
Page summary:
We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines
Change made:
Government response to consultation published.
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
Page summary:
The legislative changes will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.
Change made:
First published.
Crafting an intended purpose in the context of Software as a Medical Device (SaMD)
Page summary:
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Change made:
First published.