Abstract
The orphan drug management system can significantly improve the quality of care and that of life of patients suffering from rare diseases, and accelerate the progress of medicinal science. Withexperiences of practicing the orphan drug management system in developed countries and regions,including certification of orphan drugs, supports for developing orphan drugs, market protection and clinic application management. Based on such studies, the authors discussed the feasibility and methodology of establishing an orphan drug management system in China, along with the significance of such a system. Key words: Orphan drugs; Rare disease; Orphan drug management system
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