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    Regulatory Pathways for Orphan/Rare Pediatric Diseases: Global Overview

    This article discusses the regulatory pathways for orphan/rare pediatric diseases in China, Europe and Japan. While these regions do not have specific regulatory pathways for rare paediatric diseases as separate entities, the relevant paediatric regulations and pathways for approval are discussed. Topics include legislation, criteria for orphan drug designation and regulation, reviews and expedited pathways, incentives and advantages for applicants, such as exclusivity and...