The Medicines and Healthcare products Regulatory Agency (MHRA) is assessing the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers.
The move reflects the growth in UK marketing authorisation holders (MAHs) outsourcing some or all of their pharmacovigilance work.
The issue is that the MHRA currently carries out inspections related to an MAH. Since a contract provider may be working for several different MAHs, they could end up with multiple identical inspections.
Inspecting service providers independently has several potential advantages –
- Fewer duplicate inspections
- Less work for the MAHs as they would need to audit their providers less often if they are being directly inspected
- The ability for the MHRA to use the freed-up resource in a risk-based approach to inspections, with potential light touch inspections for MAHs if their service provider has already been inspected.
Seven service providers have volunteers to be part of the pilot – although not all will actually be inspected during the feasibility phase.
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