Pharmacovigilance Inspection Metrics Report April 2015 - March 2016
MHRA Good Pharmacovigilance Practice Inspection Metrics for 2015/16 have been published.
6th September 2016
In the period of April 2015 to March 2016, the MHRA conducted a total of 35 pharmacovigilance inspections. Approximately 23% of these inspections were of MAHs that had not previously undergone a MHRA pharmacovigilance inspection. The largest proportion of inspections was triggered due to critical findings identified at previous inspections or in response to a specific issue (54%).
The number of Critical findings identified during this reporting period had significantly decreased from the previous period, with 11 Critical findings reported versus 27 in the previous period. It is acknowledged that the total number of inspections performed had decreased by 27% from the previous period; however the reduction in critical findings indicates that significant issues identified at previous inspections were found to have been largely resolved during re-inspection.
Detailed Report is available at the following link: