The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has released statistics on the pharmacovigilance inspections it conducted between April 2013 and March 2014. While the figures continue a similar trend from previous years, MHRA says the impact of new EU pharmacovigilance legislation can be seen in the data.
Findings Compared to Previous Years
One of MHRA’s responsibilities is to ensure that companies have proper systems in place for monitoring their products after they are on the market. To enforce this requirement, MHRA conducts pharmacovigilance inspections based on the risk rating the agency gives each marketing authorization holder.
During the most recent reporting period, MHRA conducted 56 pharmacovigilance inspections, 14 of which were of companies which had not been inspected previously. These figures are roughly in line with the previous reporting period (April 2012-March 2013), during which MHRA conducted 55 inspections, 10 of which were at companies which had not been previously inspected.
While many of the figures from the report echo those from the 2012-2013 reporting period, a few trends stand out in the data. For the first time since 2010, MHRA actually conducted more inspections of innovative pharmaceutical companies than generic manufacturers. However, the overall number of inspections for the previous two years is significantly lower than in years prior.
| ||Innovative Pharmaceuticals ||Generic Manufacturers ||Other* ||Total |
*MHRA defines other as “companies … marketing mature/established, orphan, niche or herbal products.”
Additionally, MHRA identified more issues in the most recent reporting period. While there was only one more critical finding than the previous period, there was a significant uptick in "major" and "other" findings.
| ||Critical ||Major ||Other |
MHRA defines its inspection findings as follows:
“Critical: a deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines.
Major: a deficiency in pharmacovigilance systems, practices or processes that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines.
Other: a deficiency in pharmacovigilance systems, practices or processes that would not be expected to adversely affect the rights, safety or well-being of patients.”
In the 2013-2014 period, three citation categories accounted for roughly three-quarters of all critical findings. Maintenance of reference safety information was by far the most common critical finding, accounting for 42% of critical issues MHRA identified during inspections. Deficient non-interventional programs were the second most common critical finding at 21%, followed by signal management issues at 11%.
Of the 18 areas for major findings, four accounted for more than half the 192 citations. These were individual case safety reports (ICSR), signal management, quality systems and reference safety information.
Overall, MHRA saw similar trends in its inspections in the 2013-2014 reporting period compared with the 2012-2013 period. In both years, failures and delays in submitting safety information to MHRA were the most common critical finding identified by the agency.
MHRA says that effects of the EU’s new pharmacovigilance legislation could be felt. The regulator said that the increase in certain findings corresponds with areas of the legislation that were strengthened, citing the increase in quality management systems (QMS)-related findings as an example. Additionally, MHRA said that the spike in data collection issues from non-interventional studies seemed to coincide with changes in the EU legislation.
MHRA Pharmacovigilance Inspection Data