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EMA publishes draft guideline on predictive biomarker assays across product lifecycle

🇪🇺 EMA · Mon 09 Nov 2026

The agency has released the draft guideline for stakeholder consultation, setting out its expectations for assays used to select patients for treatment.

The European Medicines Agency (EMA) has published a draft guideline on predictive biomarker assays in the context of the medicinal product lifecycle. The document is now open as a draft for stakeholder consultation.

Predictive biomarker assays are used to identify patients likely to respond to a given treatment. The draft signals how EMA approaches such assays across the lifecycle of a medicinal product, rather than at a single stage.

The source material available to VigiEye does not set out the guideline's specific requirements, the consultation deadline or how it relates to existing guidance. Those details should be checked against the full draft text on the EMA website.

As general context, a draft guideline published for consultation is not final. EMA normally reviews stakeholder comments before deciding on a final version, so the content may change.

What it means for your team

  • Regulatory teams should obtain the full draft and check the consultation timetable, as the source gives no detail on requirements or dates.
  • Sponsors using biomarkers to select patients may wish to review how the draft could affect clinical development and companion diagnostic planning.
  • QA and PV functions involved in assay oversight should follow the consultation, since the draft indicates EMA's expectations for these assays.
  • Organisations may consider submitting comments during consultation if the draft touches their programmes.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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