China FDA Publishes Guidance for Priority Review

Priority review will be possible in China for novel drug candidates.

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:

  • never having been marketed in or outside China;
  • having their manufacture transferred to China;
  • using innovative technology or offering “significant treatment advantages”;
  • having patent protection that will soon expire (in three years for a clinical trial application or one year for a commercial application);
  • being a “Chinese medicine (including ethnic medicine) with clear clinical positioning in the prevention and treatment of major diseases”;
  • being a drug candidates involved in a state-sponsored project;
  • being in clinical testing or approved in the US/EU and intended to be produced with the “same production line in China”;
  • providing "significant clinical advantage" for the treatment or prevention of a number of diseases, including AIDS, tuberculosis, viral hepatitis, rare diseases, malignant tumors, pediatric diseases or diseases affecting the elderly;
  • being pediatric drugs approved outside China with supporting pediatric clinical data

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.

  

Cynthia A. Challener, Ph.D.

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.