Abstract: OBJECTIVE To put forward suggestions for orphan drug administration in China. METHODS System comparison was used. RESULTS According to issued "Orphan Drug Act" for promoting orphan drug R&D, manufacturing and marketing, European Union achieved quite significant results. It was benefited from that EU taking various effective policy measures to manage orphan drug of this field, mainly in consolidating the key legislative basis and enhancing system operability, improving special approval procedures and financial support to R&D investment, etc.. These measures would confidently benefit China of orphan drug development and improving policies management in the future by providing abundant and valuable experience. CONCLUSION We should better build the orphan drug management in China, complete the orphan drug approval system, promote transformation from the achievement of basic research for orphan drug to application area.