The Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate has released guidance to Marketing Authorisation Holders (MAHs) with regards to considerations for agreements with Pharmacovigilance (PV) system service providers.
MAHs often depend on multiple third parties for their PV systems, which involves extensive outsourcing and partnering. The majority of service providers offer a valuable and compliant support, however the MHRA Inspectorate has identified that MAHs do not always include adequate text in written agreements to allow management of the outsourced activities and the risk of serious pharmacovigilance failures. Even when the activity has been contracted out, the MAH retains responsibility for compliant activity.
Risk factors for PV systems are listed in Module III of Good Vigilance Practices (GVP), however the ease with which the regulatory framework addresses third party working changes in PV service provision may lead to an underestimation of the PV compliance risks.
The MHRA Inspectorate has identified several areas where challenges may occur:
- Data integrity and control.
- Record-keeping – When subcontracting pharmacovigilance activities, the ownership and provision of safety data, source records and derived datasets needs to be clearly allocated in agreements.
- Data migration – The MAH is responsible for data integrity when using a third party, risk of data loss needs to be minimised, especially during transfers.
- Oversight and supervision.
- Transparency – MAHs and service providers need to share information about pharmacovigilance risk and compliance to assess impact and address deficiencies.
- Governance and performance – The MAH must have appropriate mechanisms to ensure that service provider performance is overseen and action can be taken if problems arise.
- QPPV oversight – The QPPV must have authority over the pharmacovigilance system, though the MAH remains responsible for the delivery of pharmacovigilance.
- Contracts and agreement.
- MHRA recommend that organisations (both service providers and MAHs) work together to construct agreements that, in addition to describing specific pharmacovigilance tasks, limit the potential for pharmacovigilance failures arising from outsourcing services.
To read more about what the MHRA Inspectorate has to say on this important matter, please click here.