The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug approvals. In November 2018, in an unprecedented regulatory action, NMPA called on global pharmaceutical companies to bring 48 innovative drugs to China. These drug products are indicated for rare diseases or other life-threatening diseases and have already been approved in the U.S., EU, or Japan. Significantly, once the drug sponsors can submit data demonstrating no ethnic differences for the efficacy, the drug products can be approved without any additional clinical trials in China. In December 2018, AstraZeneca and its China partner, FibroGen, received NMPA’s market authorization for their roxadustat, a firstin-class anemia drug for kidney patients. This is the first time NMPA approved an innovative drug product from a global pharmaceutical company before any other country in the world. Notably, at a press conference in February 2019, senior officials from NMPA told reporters that a total of 18 new cancer drugs were approved in China in 2018, which marks a 157% increase in comparison with 2017. Further, the average review time for these cancer drugs in 2018 was 12 months, down from 24 months prior to 2018.

Originally published in FDLI, Update magazine - April/May 2019.