Whitepaper | 3/1/2022

An Overview of China’s Market Approval Policy and Medical Insurance Payment System for Rare Disease Drugs

Yajie Li, Vice President Technical, Parexel Regulatory and Access Consulting; Gary Cheng, Vice President, Health Advances; Eric Woo, Senior Analyst, Health Advances; Jinchuan Guo, Director of Information Research, Illness Challenge Foundation
According to the World Health Organization, there are around 5,000 – 8,000 rare diseases that have been recognized across the world. In China, rare diseases are recognized in the National Rare Diseases List. In May 2018, the National Health Commission of China published the List of Rare Diseases (First List), covering 121 indications that affect up to three million patients to provide a reference for the rare disease drug review. Since 2021, the compilation of the second list of rare diseases is also in progress under the guidance of the National Health Commission.
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