China Proposes Revised Drug Registration Rules

Friday, August 5, 2016

Source: BioCentury

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.

According to law firm Ropes and Gray, the revised rules would alter innovator exclusivity by eliminating the linkage between patent protection and drug approvals, allowing CFDA to approve products that infringe on active patents. Sponsors of competing applications would be required to provide a statement to CFDA stating that the product does not infringe.

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