Publish every complete response letter and negative opinion across all regulators
When a regulator rejects a cancer drug, the reasons are usually secret. Publishing them everywhere would stop other countries and companies repeating the same mistakes.
FDA began publishing complete response letters in 2025; EMA publishes refusal assessment reports; most other regulators publish nothing on negative decisions. Sponsors routinely describe rejections selectively. The proposal is a standing commitment across ICH members to publish all negative decisions and their reasons within 30 days, indexed alongside approvals, so that other regulators can rely on negative as well as positive assessments and developers can learn what evidence was insufficient.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Failures are hidden · Negative trials, failed drugs and abandoned programmes are rarely published, so the same mistakes are repeated.
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.
- IdeaA public index of how the same cancer drug's label differs between countries
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, Failures are hidden.
- IdeaMake post-progression sampling a condition of accelerated approval
Shares Failures are hidden, Regulatory divergence between regions.
- IdeaRequire every oncology candidate to publish how much reaches the brain
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Failures are hidden.
- IdeaA standing rulebook for one-patient treatments
Shares Failures are hidden, Regulatory divergence between regions.