RESUMO
OBJECTIVE: To learn from several developed countries and regions about their experience of orphan drug registration management and to explore appropriate orphan drug registration policy for China. METHODS: The orphan drug registration policies of America, Japan, EU, Australia and Taiwan were analyze and compared, and the history and current situation of the orphan drug registration in China were summarized. RESULTS: It has been a common trend in the world to use "designation of drugs + market approval" pattern for orphan drug registration, which has promoted the development of orphan drugs and increased the accessibility of orphan drugs in the above-mentioned countries and regions. CONCLUSION: Related government departments in China should learn the advanced experience and establish our orphan drug system as soon as possible, at the same time, we should keep improving the orphan drug registration policy in China.