{"entity":{"id":"idea-reg-label-divergence-index","kind":"idea","name":"A public index of how the same cancer drug's label differs between countries","aka":[],"tldr":"Nobody keeps track of how differently the same drug is approved and dosed around the world. A public scoreboard would make the differences visible and push regulators to converge.","summary":"For the same oncology drug, the approved indications, biomarker requirements, dosing and line of therapy can differ between FDA, EMA, PMDA, NMPA and others, and the reasons are rarely documented. The proposal is an open, machine-readable dataset that parses approved labels for every oncology drug across at least ten regulators, scores divergence per indication, and publishes the reasons where regulators have stated them. Regulators and sponsors would receive an annual divergence report.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis"}],"tags":[],"related":["fda-approvals"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-knowledge-diffusion"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Publishing a divergence index is followed within three years by a measurable reduction in the divergence score for new approvals and an increase in the number of harmonising label variations.","rationale":"Measurement changes behaviour; the W.A.I.T. indicator changed the conversation on European access delays. Divergence that is visible must be justified, and much of it has no scientific justification.","test":"Build the index for 50 oncology drugs across ten regulators, publish it, and track divergence scores and harmonising variations annually.","maturity":"speculative","actor":"data","cost":"small","horizonYears":2},"route":"/ideas/idea-reg-label-divergence-index/","neighbours":{"collection":[{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","route":"/collections/fda-approvals/"}],"bottleneck":[{"id":"b-knowledge-diffusion","kind":"bottleneck","name":"Knowledge reaches practice too slowly","route":"/bottlenecks/b-knowledge-diffusion/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}