Overview of current policy for rare disease in China

2018 was regarded as a milestone of rare disease management in China as, for the first time after decades of negligence in this area, China published the First List of Rare Diseases (FLRDs). This was a key step in improving and standardising the regulatory system of rare disease management, orphan drug development, and review and approval.

In this FLRDs, 121 diseases were included and officially defined as rare diseases. Since then, a series of regulations and policies have been released and implemented to support the development of rare disease treatment and management.

Several key trends on the current policy and market dynamics for rare disease in China are outlined in this paper. With strong expertise and deep understanding of the rare disease field in China, Deallus is well-positioned to support Pharma to fully understand the current landscape and maximise success in the market.

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