China proposes revised Drug Registration Rules

CFDA has issued new proposals to revamp China's Drug Registration Rules (DRR) that offer a mixed bag of updated policies that could stymie or promote innovation, according to life sciences legal specialists in China.

The revisions, which are tantamount to revising the Food, Drug and Cosmetic Act in the U.S., are based on State Council reforms released last year that offered the prospect of eliminating a backlog of drug reviews, updating China's drug classification system and reforming clinical trial rules to allow parallel drug development in and outside of China (see BioCentury Extra, Aug. 19, 2015). ...