Key takeaways from the MHRA GPvP symposium

The 2024 MHRA Good Pharmacovigilance Practice (GPvP) symposium offered a deep dive into GPvP inspection non-compliance, metrics and trends, regulatory updates, and an opportunity to hear about the MHRA’s perspective on hot topics in pharmacovigilance.

A week after attending the symposium, I wanted to highlight some of my key takeaway points.

4 critical findings were identified in the MHRA inspection period (2022/2023):

  • Signal management
  • Maintenance of the RSI
  • Additional Risk minimisation measures
  • Additional risk minimisation activities

*Between 2016 and 2023, topics where the highest number of findings overall were Risk Management, Ongoing Safety Evaluation and the Quality Management systems.

These are the same topics that come up year after year and are an area of real focus in MHRA inspections as they are some of the areas, from a PV perspective, with the highest risk to patients.

The Windsor Framework (WF) and the impact on PV:

Set to come into force on 1st January 2025.

Only products under the mandatory scope of the Centralised Procedure (CP) are in the scope of the Windsor Framework.

There will be two licence types after January 2025:

  • PLNI (Under MR/DCP)
  • UKPL (UK MA- within the scope of WF and UK MA-outside of the scope of WF)

For UK MA (Non- CAPs) and PLNI PV requirements remain in line with the EU legislation.

For UK MA (CAPs) PV requirements are as currently for GB MA’s.

No change in location of the UK QPPV or for the format and content of the PSMF for either type of licence.

Remote compliance assessment

This is a new tool that the MHRA is implementing in certain circumstances, to follow up critical or major findings from GPvP inspections. It provides a targeted review of compliance and allows a narrower scope and lower inspection fees for companies.

Feedback received from the pilot MAHs involved in this process in 2023 said they thought workload wise, the burden was similar whether the inspection was remote or not.

An interesting point to note: MHRA confirmed that desktop audits can be used in an audit schedule to assess compliance of partners. However these desktop audits must go further than just a questionnaire: specific evidence to support responses needs to be provided along with supporting documentation.

Sharon Corbett
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