At the April 12, 2018 executive meeting of the State Council in China, Premier Mr. Li Keqiang indicated the government’s desire to increase China’s access to innovative drugs. To achieve this, the government would encourage importation of innovative drugs into China by streamlining the regulatory pathway, enhancing IP protection, and lowering the cost of medicine. Shortly thereafter, the Chinese Food and Drug Administration (CFDA) published draft guidelines on May 12, 2018 and asked for comments. Below is a summary of where things stand today.
