The Medicines and Healthcare products Regulatory Agency (MHRA) has embarked on a recent initiative to evaluate the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers.
In July 2003 MHRA introduced a statutory pharmacovigilance inspection programme of marketing authorisation holders (MAHs) in the United Kingdom. The revised 2010 EU pharmacovigilance legislation and good vigilance practice (GVP) guidance has strengthened our remit to inspect organisations that provide contract services for pharmacovigilance.
Article 111 of Directive 2010/84/EU (amending 2001/83/EC) 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".
Our inspection experience to date has shown that there are many models through which MAHs undertake pharmacovigilance activities. It is increasingly common for a MAH to outsource some or all of their pharmacovigilance activities to a contract service provider. Good vigilance practice (GVP) module I states that MAHs may transfer any or all of the pharmacovigilance tasks or functions to another person or organisation.
We currently inspect the pharmacovigilance systems, processes and procedures of service providers during our pharmacovigilance inspections of a MAH. Therefore, the activities undertaken by a particular service provider may be reviewed multiple times, depending on the number of MAHs who have subcontracted activities to that company. The cost of inspecting a contract service provider is covered by the fee charged to a particular MAH and the repeated inspection of a given service provider involves repeated costs (recovered by the fee charged to each individual MAH).
Implementing fee-bearing pharmacovigilance inspections of service providers may have benefits for the service providers and MHRA, which include:
- a possible reduction in the number of times a service provide would be inspected
- the frequency for each MAH to individually audit their service providers, as part of the MAH’s risk-based audit programme, may be reduced if stand-alone inspections of service providers are conducted by the MHRA
- possible allocation of MHRA resource where required in a risk-based fashion (as currently happens for MAHs) - 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 (although an evaluation of interfaces and oversight by the MAH may still be required)
These inspections could be an effective tool to increase compliance and improve the protection of public health, by ensuring pharmacovigilance service providers implement appropriate system changes across all client organisations, where non-compliance is identified.
Feasibility assessment and next steps
In October 2014, 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 and allowing MHRA to continue in its remit to protect public health in the most efficient way. As part of the survey, we also requested volunteers to participate in a pilot phase of fee-bearing inspections, planned for the financial year 2015/16.
Of the 22 contract service providers contacted, 10 responded to the survey and 7 of those volunteered to participate in the pilot phase.
It will not be feasible for MHRA to inspect all of the organisations that have volunteered as part of the pilot phase.
Currently 2 organisations have been contacted for inspection by the good pharmacovigilance practice (GPvP) Inspectorate; which are due to take place in Q2 and Q3 2015/16.
Don’t miss the next blog, sign up to be notified by email when a new post comes out.
Check out our guidance on good practice for information on the inspection process and staying compliant.