The Medicines and Healthcare products Regulatory Agency (MHRA) has released the pharmacovigilance inspection metrics report covering the period from April 2013 to March 2014. During this period the MHRA conducted 56 inspections of Marketing Authorisation Holders (MAH). The largest proportion of these were performed as routine re-inspections, while 12 were triggered due to critical findings from previous inspections or in response to a specific issue, 19 were performed to fulfil the EMEA programme of inspections relating to centrally authorised products, and two were requested by the European Committee for Medicinal Products for Human Use (CHMP). Out of the 56 inspections, 19 critical, 192 major and 172 other findings were identified during this period. The 19 critical findings were from 16 different inspections and can be broken up into the following categories:
- Maintenance of reference safety information (42%) – failures and significant delays to submit safety variations to update the safety sections of Summary of Product Characteristics (SmPC) and Patient Information Leafletes (PILs).
- Non-interventional programmes (21%)
- Signal management (11%)
- Complete system failure (6%)
- Individual Case Safety Report (ICSR) Data management (5%)
- Pharmacovigilance quality management system (5%)
- EU-QPPV (5%)
- Periodic Safety Update Report (PSUR) production (5%)
Major findings were identified across 18 categories, with the largest proportion of major findings identified in relation to spontaneous case processing, representing 16% of all major findings. The four most common categories in which major findings were identified were spontaneous case processing, signal management, quality systems and reference safety information, representing 50% of all major findings identified.
The impact of the revised pharmacovigilance legislation was more apparent in this reporting period. In areas where legislation and guidance has been strengthened, an increased number of inspection findings have been reported. Examples include: an increased number of findings across the Quality Management System, incorporating pharmacovigilance auditing, training and procedures, representing a 66% increase in the average number of QMS findings identified; an increased number of inspection findings following the introduction of the Pharmacovigilance Master File; and an increase in the number of findings reported in association with deficiencies in the collection of data from non-interventional studies which has increased due to the changes in the data collection requirements introduced in the revised legislation.