ideasIdea
Regulators recognise each other's companion diagnostic approvals
A test approved to select patients for a drug in the US must go through separate approval in Europe, Japan and elsewhere, delaying the drug. Accepting each other's test approvals would fix the delay.
Companion diagnostics are regulated separately from drugs and differently by region (FDA premarket approval, EU IVDR, PMDA). Divergence delays drug access and multiplies bridging studies. A mutual-recognition agreement for companion diagnostics among ICH-aligned regulators, analogous to Project Orbis for drugs, with a shared analytical validation dossier and a single bridging-study standard, would remove months to years of delay.
Hypothesis
Mutual recognition reduces the median lag between drug approval and companion diagnostic availability in the second region from over a year to under three months.
Rationale
Project Orbis and the Access Consortium show that regulators can share reviews; analytical validation of a test is less region-dependent than clinical practice.
What would test it
Pilot recognition of five companion diagnostics between two regulators and measure time to availability against contemporaneous non-pilot tests.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.