MHRA Pharmacovigilance Inspection Metrics Report Published

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The MHRA (Medicines & Healthcare products Regulatory Agency) GPvP (Good pharmacovigilance practice) inspectorate recently published their latest inspection metrics report.

During the period 01 April 2014 to 31 March 2015, the MHRA conducted a total of 48 pharmacovigilance inspections. Approximately 29% of these inspections were of marketing authorisation holders (MAH) that had not previously undergone a MHRA pharmacovigilance inspection. The largest proportion of inspections (21 inspections) was performed as routine re-inspections (i.e. of MAHs who had previously undergone a pharmacovigilance inspection). 

A total of 27 Critical, 169 Major and 155 Minor findings were identified during this period. The number of Critical findings identified during this reporting period had increased from the previous period (19 Critical findings) and were found during 17 of the 48 inspections that were performed.

The majority of Critical findings were reported in relation to the maintenance of reference safety information, representing 29% of all Critical findings identified. Critical findings associated with reference safety information were (again) characterised by failures and significant delays to submit safety variations to update the safety sections of SPCs (summaries of product characteristics) and PILs (patient information leaflets).

In this reporting period, Critical deficiencies associated with signal management represented the next largest proportion of findings identified (26% of all Critical findings). A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. These signals can be generated from several sources such as spontaneous reports, clinical studies and scientific publications. Seven critical findings were reported and these were associated with:

• failures to conduct signal detection activities
• failures to incorporate all available data into signal detection activities
• significant delays in completing signal evaluation
• failures to address previously reported major inspection findings, resulting in an escalation of the issue (persistent non-compliance)

In some instances the persistent non-compliance had had a measurable impact. Subsequent completion of signal detection activities had resulted in new signals being identified and updates to product information.

Further Critical findings were identified in relation to:

• MAH oversight of the pharmacovigilance system
• pharmacovigilance quality management system
• risk management system

A single Critical finding was identified in each of the following areas:

• complete system failure
• PSURs (periodic safety update report)
• case processing 
• submission of false and misleading information to EMA

There were no Critical findings in relation to non-interventional programmes compared to four reported during the April 2013-March 2014 period.

The topic areas representing the major proportion of inspection findings remain associated with key pharmacovigilance activities and outputs such as ICSR management, signal management and reference safety information.

To find out further details please see the complete Pharmacovigilance inspection metrics report available on GOV.UK.