Abstract
This comment analyzes the recent “Provisions for Drug Registration (Revised)” released by China's Food and Drug Administration (CFDA). In this revised edition, detailed comparative analysis was made of the contents of and changes to the previous provisions, such as establishment of the priority review system, improvement in the protection system for traditional Chinese medicine, modification of the patent linkage system, improvement in the criteria for generic and biologic drugs, and so on. The future development trends of China's pharmaceutical industry were unfolded from drug patent layout, time limit for drug review, and ideas for the supervision of traditional Chinese medicine. It is argued in this comment that great importance has been attached to the pharmaceutical industry in China, but that aspects of the review and supervision require greater analysis.
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