Companion Diagnostics

A companion diagnostic (CDx) is an IVD providing information essential for the safe and effective use of a corresponding therapeutic product. ANVISA regulates CDx as IVDs under RDC 36/2015.

The CDx must be registered separately from the drug it supports. The registration dossier must include analytical and clinical performance data demonstrating ability to identify patients who will benefit from the paired therapy. ANVISA coordinates the review of CDx with GGMED where the CDx and drug are submitted concurrently. Labelling must reference the specific drug for which the CDx is intended.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.