Primary source: European Medicines Agency (EMA)
The EMA has published comments on the draft ICH E22 guideline that may affect the integration of patient preference data in regulatory assessments, including RMPs.
Understanding stakeholder feedback on the draft guideline will guide the integration of patient preference data in future benefit-risk assessments, thereby influencing regulatory decision-making.
Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Aggregation and publication of stakeholder feedback on the draft guideline for patient preference studies.
While still in draft, the published comments provide insight into regulatory expectations for the use of patient preference data in benefit-risk assessments and RMPs.
Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.
The European Medicines Agency (EMA) has published an overview of comments received during the public consultation for the draft ICH E22 guideline on patient preference studies. This document reflects stakeholder feedback and provides insights into regulatory expectations for the use of patient preference data in benefit-risk assessments and Risk Management Plans (RMPs).
What changed: The EMA has published comments on the draft ICH E22 guideline that may affect the integration of patient preference data in regulatory assessments, including RMPs.
Why it matters: Understanding stakeholder feedback on the draft guideline will guide the integration of patient preference data in future benefit-risk assessments, thereby influencing regulatory decision-making.
Practical implication: Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.
Published from the Firecrawl policy change extraction pipeline.
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