{"entity":{"id":"idea-reg-shared-postmarketing-registry-condition","kind":"idea","name":"One international registry, not one per country, for conditional approvals","aka":[],"tldr":"When a drug is approved early, each country often demands its own follow-up study. A single shared registry would answer the safety questions faster and better.","summary":"Post-authorisation safety and efficacy studies are imposed region by region, producing several small, slow registries for the same product. The proposal is for regulators participating in concurrent review to agree a single international registry protocol (core dataset, governance, open aggregate reporting) as the shared condition, hosted by an academic consortium with sponsor funding. National regulators receive the same interim analyses on the same schedule.","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":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-real-world-evidence"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"A shared registry reaches the pre-specified sample size for its primary safety question at least twice as fast as the median regional post-authorisation study and results in fewer unmet post-marketing commitments.","rationale":"Rare adverse events and effectiveness in under-represented groups need numbers that no single region accrues quickly; pooling is the only way to answer them within the drug's useful life.","test":"Pilot with the next three concurrent conditional oncology approvals across FDA, EMA and MHRA, with one shared registry each, and compare time to primary analysis with each agency's prior post-authorisation studies.","maturity":"speculative","actor":"regulator","cost":"medium","horizonYears":4},"route":"/ideas/idea-reg-shared-postmarketing-registry-condition/","neighbours":{"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}]}}