MHRA to launch pilot inspections of contract pharmacovigilance service providers

12-Aug-2015 - Last updated on 12-Aug-2015 at 22:17 GMT

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working on a pilot project investigating the feasibility of inspecting pharmacovigilance contract service providers as it’s becoming increasingly common for a MAH (marketing authorisation holder) to outsource the work.

The investigation into conducting the stand-alone, fee-bearing inspections of pharmacovigilance service providers comes as the regulator currently inspects such systems, processes and procedures during inspections of MAHs, but often times these inspections are redundant.

Reducing the number of times a service provider would be inspected is seen as one of the major driving forces for inspecting the service providers, especially as MAHs also have to individually audit their service providers, as part of the MAH’s risk-based audit programme, according to a MHRA blog post.

“It may be possible to cover the activities that support multiple MAHs at a single inspection of the service provider, which may result in a reduced inspection scope of MAH inspections, where a service provider had previously been evaluated as part of a stand-alone inspection,” the regulator says.

The MHRA also notes that the revised 2010 EU pharmacovigilance legislation and good vigilance practice (GVP) guidance from the EMA has strengthened its ability to inspect organisations that provide contract services for pharmacovigilance.

In addition, Article 111 of Directive 2010/84/EU includes the provision for competent authorities to "inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX."

In 2014, 16 of the total 58 pharmacovigilance inspections were conducted at the premises of contractors and subcontractors, according to an EMA report.

Pilot Program

Currently two unidentified contract service providers have been contacted for inspection by the good pharmacovigilance practice (GPvP) Inspectorate of the MHRA, and the inspections are expected to take place in Q2 and Q3.

The pilot comes as last October, MHRA contacted 22 contract service providers and offered them the opportunity to complete a survey, aimed at assisting us in assessing the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers.

Of the 22 contract service providers contacted, 10 responded to the survey and seven of those volunteered to participate in the pilot phase. But the MHRA will only begin with these two companies as it claims it’s not feasible to inspect all of the organisations that volunteered.