A reliance pathway for companion diagnostics so the test arrives with the drug

In vitro diagnostic regulation has fragmented further since the EU IVDR: a companion diagnostic cleared by FDA as a PMA needs a separate notified-body assessment in Europe and different routes in Japan, China and Brazil. Because the drug is unusable without the test, this delay is a drug access delay. The proposal is a reliance route under which a companion diagnostic approved alongside a drug by a WHO-listed authority is accepted for that indication, with local requirements limited to laboratory accreditation and proficiency testing.