One international registry, not one per country, for conditional approvals
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.
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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
Pages like this
not linked directly; found by shared links- IdeaGood practice standards and inspection for real-world data sources
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaRequire post-approval evidence in patients over 75 and update labels accordingly
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaEvery patient on an accelerated-approval drug enrolled in a registry until confirmation
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaLinked prescribing and outcome data to find drug interactions with cancer therapy
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaWearable activity data as a validated real-world endpoint
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaNo mCODE, no payment: tie oncology reimbursement to a minimal structured record
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaRequire genetic and target-trial evidence before funding any repurposing phase 3
Shares Weak real-world evidence and registries, Real-world evidence.
- IdeaAn automated pipeline emulating trials of every common drug against every cancer
Shares Weak real-world evidence and registries, Real-world evidence.