The Marketing Authorization Holder system was a drug management system commonly adopted by the world today，the core of which was to separate the drug marketing approval from the drug production approval. In order to break the limitations of the current “bundled” management of drug registration and approval in China，and encourage innovation in the drug research and development，on August 18，2015，China proposed to carry out the pilot program for Marketing Authorization Holder，with an implementation period of 3 years. As of November 4，2018，the three-year pilot period had expired，and the pilot program achieved positive results. In order to better summarize the pilot experience and get integrated with the revision of the Drug Administration Law，China decided to extend the pilot period by one year on October 26，2018. This report summarized the pilot situation and implementation achievements of MAH system in the past three years，analyzed the related risks and proposed countermeasures to provide reference for promoting the reform of drug review and approval system in the future，so as to lay a good foundation for improving the drug management system.