{"entity":{"id":"idea-reg-publish-all-rejections","kind":"idea","name":"Publish every complete response letter and negative opinion across all regulators","aka":[],"tldr":"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.","summary":"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.","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-negative-results"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Systematic publication of rejections reduces resubmissions with the same deficiency and reduces the number of products approved in one region after rejection in another for the same evidence package.","rationale":"Negative decisions carry as much information as positive ones and currently reach only the sponsor. Publication also deters approval shopping between jurisdictions.","test":"Analyse the first two years of published FDA CRLs for oncology to quantify the share disclosed accurately by sponsors beforehand; extend publication commitments through ICH and monitor resubmission patterns.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":2},"route":"/ideas/idea-reg-publish-all-rejections/","neighbours":{"collection":[{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","route":"/collections/fda-approvals/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}