Known for its relatively relaxed regulations on companion diagnostics (CDx), guidance from the European Medicines Agency is not expected until there is more experience with these drug-device products, an expert says.
Nevertheless, the regulation of CDx in Europe is likely to change under an upcoming revision of the European Commission’s in vitro diagnostic (IVD) directive. The revision, which will result in an EU-wide IVD regulation, would make CDx Class C devices and require notified body involvement for review of technical documentation, Bruno Flamion, former chair of the EMA’s Scientific Advice Working Party, said at the Next Generation Summit in Washington, D.C., on Aug. 22.
Currently, CDx are regulated in the EU through a self-certification process under the IVD directive, and there’s a tendency for companies to cut corners in design and development, said Maham Ansari, senior regulatory affairs associate at OptumInsight. And unlike in the U.S., China and Japan, clinical trials of CDx are not required in the EU.
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