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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.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Regulatory divergence between regions.
Shares Failures are hidden, Regulatory divergence between regions.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Failures are hidden.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Failures are hidden.
Shares Failures are hidden, Regulatory divergence between regions.