New MHRA Risk Based Inspection Process Announced

This information is for the attention of organisations involved in sponsoring or hosting clinical trials.

The MHRA has now moved over to a Risk Based Inspection Process. The process will use a combination of information provided to the MHRA including a GCP Compliance Report.

Please refer to the MHRA website for further information about the Risk Based Inspection Process and to download a copy of the GCP Compliance Report template: http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice/Riskbasedinspections/index.htm  

GCP Compliance Reports should be submitted to the MHRA by June 30 via the following address: gcpriskbasedinspections@mhra.gsi.gov.uk  

Any questions relating to submission of the Compliance Report should be directed to the MHRA GCP inspection mailbox: gcpriskbasedinspections@mhra.gsi.gov.uk