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    EU Accelerated Pathways

    This article summarizes accelerated pathways for regulatory approval for new drug or biologic development in the European Union (EU), including requirements for conditional marketing authorization, authorization under exceptional circumstances, accelerated assessment and Priority Medicines Scheme (PRIME) in addition to accelerated pathway requirements associated with orphan drug designation.   Introduction   Why pursue special designations and pathways?   The...
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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...