China issues new drug approval guidelines

China's State Council issued new drug approval guidelines Tuesday intended to eliminate China FDA's application backlog by YE16 and ensure that by 2018 review of all marketing applications submitted to CFDA would be completed within a set timeline.

According to an analysis by Sidley Austin LLP, which specializes in Asia-Pacific life sciences law, the guidelines will update China's drug classification system. Only drugs not yet approved anywhere in the world will be classified as "new drugs." A subcategory of innovative new drugs, including treatments for HIV, cancer and rare diseases, is eligible for expedited review. ...