January 9, 2018 PAO-M01-18-NI-013
China’s Food and Drug Administration (CFDA) began 2018 with issuance of a guidance document outlining the criteria that must be met for a drug candidate to receive priority review. The goal of the priority review process is to accelerate the development of drugs with "significant clinical value".
To qualify for priority review, novel drugs must meet at least one of several different criteria, which include:
Acceleration of drug approvals through the use of a priority review process was recommended by China’s State Council in a directive issued in advance of the 19th National Congress of the Communist Party of China, which was held in the fall of 2017.
Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.