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Patient safety redefined. Digitised, personalised and optimised.

Updated pharmacovigilance guidance

(GVP XVI, revision 3)

Axian Consulting Ltd.

The European Medicines Agency (EMA) is expected to publish an update of the EMA Good Pharmacovigilance Guidance Module XVI (Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)) during 2023.

A draft of this update was released for public consultation in February 2021. The EMA used the consultation feedback to revise the draft and align it with the addendum on pregnancy prevention measure published in March 2022.

If the final version stays true to the February 2021 draft, the greatest impact will be a regulatory requirement to evaluate the effectiveness of additional risk minimisation measures (aRMMs) such as educational materials. This means that companies will need to evaluate their aRMMs more often and act on their findings (enhancing aRMMs or retiring ones no longer needed).

The draft described three evaluation principles:

  • Focused evaluation (of risks with major implications for public health);
  • Regular evaluation (at specified intervals after launch); and
  • Evaluation of intended and unintended outcomes (improved knowledge and behaviours versus undue burdens or decreased use of beneficial medicines).

The challenges of survey-based evaluation approaches are well known, including difficulties in engaging participants and the risks of bias. Better ways to obtain the data to fulfil these new obligations will be needed. Some of these may be described in an addendum to the updated guidance.

Traditionally, aRMMs have been delivered to their intended audiences as paper-based materials such as guides, patient cards, and so on. As leaders in the digital space, Axian looks forward to seeing if the new guidance covers digital aRMMs. The draft update acknowledged the potential of digital approaches but did not describe these in any detail, nor discuss their known advantages. Axian understands that feedback on the draft covered digital and hopes to see more guidance in this area in the final version.

Other areas revised in the draft included:

  • Clarifications on the role of risk minimisation for risk management planning and its impact on the benefit-risk balance of medicines
  • Explanation of controlled access systems
  • Involvement of stakeholders (healthcare professionals and patients) in aRMM development, dissemination, and evaluation, in discussion with the EMA, its committees, and competent authorities

Axian is looking forward to the publication of the final draft. Stay tuned for our comments following its publication at the end of March.

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