The UK MHRA has just released the inspectionmetrics report corresponding to the period April 2011 through March 2012.
During the current reporting period average number of findings has decreased slightly compared to the previous reporting period. Overall, the average number of findings identified at inspections has decreased significantly since 2006.
Of the nineteen critical findings identified during the period, three were identified during inspections of MAHs who have not previously undergone an MHRA pharmacovigilance inspection compared to fifteen from routine re-inspections and one from a triggered inspection. Ten of the critical findings were identified during inspections of MAHs classified as Innovative compared to four during inspections of MAHs classified as Generic and five classified as Other.
As per previous inspection reports, a large number of critical and major findings were identified in the areas of case processing, PSURs, ongoing safety evaluation (signal generation), contracts and agreements and reference safety information. Findings relating to reference safety information include failure of MAHs to ensure that the safety information in SPCs and PILs is up-to-date, that safety variations are submitted in a timely manner and that approved product information is made available to manufacturing sites; in many cases these findings have led to significant post inspection actions. Additional areas in which findings are being reported more frequently than previously are handling of data from patient support programmes and MAH oversight.
Of note, with the implementation of the new pharmacovigilance legislation in July 2012, revisions to the manner in which MHRA categorises and groups findings may occur in the future. Information about the new pharmacovigilance legislation is available on the MHRA website.