Analysis of China's new drug creation incentives in the new period

In 2015, the State Council issued the Opinions on Reforming the System for the Review and Approval of Drugs and Medical Devices (Guo Fa [2015] No. 44), which opened the prelude to China's new drug encouragement policy. The newly revised "Pharmaceutical Administration Law of the People's Republic of China" was formally implemented on December 1, 2019, and the results of China's new drug encouragement policy in the new period were determined in the form of law. China's new drug policy reform takes the review and approval system as a breakthrough, and gradually covers multiple industrial links such as clinical trial management, intellectual property protection, drug marketing authorization holder system (MAH) pilot, and innovative drugs entering the medical insurance drug catalog. The policy environment for new drug creation in China has been fundamentally improved, and the development of innovative drugs has entered a period of historical opportunity.