MHRA Inspection Report Shows Problems in Pharmacovigilance Training

April 22, 2015

UK inspectors cited 19 companies for critical pharmacovigilance weaknesses in the fiscal year ending March 31, 2014, roughly even with the 18 citations in the previous year.

Roughly 42 percent resulted from drugmakers failing to submit updates to safety sections of their product summaries and patient information leaflets, according to the annual report by the UK’s Medicines and Healthcare Products Regulatory Agency.

Revised pharmacovigilance legislation, which became effective in July 2012, caused more inspection findings in areas where the legislation and guidance have been strengthened, the MHRA says, such as weaknesses in pharmacovigilance auditing, training and procedures that represented a 66 percent hike in the number of findings identified.

Nevertheless, the main areas of minor inspection findings remained associated with key pharmacovigilance activities and outputs such as individual case study report management, signal management and reference safety information, the agency adds.

The MHRA targeted manufacturers that had not previously undergone a pharmacovigilance inspection. Routine re-inspections continued to represent the largest proportion of inspections.

Read the report here: www.fdanews.com/03-15-MHRA-Pharmacovigilance.pdf. — Jonathon Shacat