A public index of how the same cancer drug's label differs between countries
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.
For many oncology drugs the approved indications, biomarker requirements, dosing and line of therapy 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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Knowledge reaches practice too slowly · Knowledge diffusion is slow: it takes years for a proven result to change what most patients receive, and no one can keep up with the literature.
Pages like this
not linked directly; found by shared links- IdeaTurn Project Orbis into a work-sharing review with one shared assessment report
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaEvery regulator publishes its full assessment report so others can rely on it
Shares Knowledge reaches practice too slowly, Regulatory divergence between regions.
- IdeaPrint the participation-to-prevalence ratio in every drug label and assessment report
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.
- IdeaA 'dose evidence' panel in every label: how many doses were tested, and how
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.
- IdeaPublish every complete response letter and negative opinion across all regulators
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaLive tracker of the lag from first approval to real availability in every country
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaConditional approvals that lapse automatically if the confirmatory trial is late
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
- IdeaA public registry of cancer treatments that were later shown not to work
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.