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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.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries, Regulatory divergence between regions.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.
Shares Real-world evidence, Weak real-world evidence and registries.