Newfound regulatory stability in China contributing to biotech boom
Two major developments in China—the government’s shift to a U.S. FDA-style of drug approvals and its new membership in the global “harmonization” consortium ICH—have created a level of regulatory stability that promises to accelerate the already booming Chinese biotech industry. For decades, the Chinese drug industry has been characterized by the production of raw ingredients and, occasionally, generic drugs. However, thanks to the Chinese government’s crackdown on corruption and sweeping changes to the research and approval system, newfound predictability of the regulatory process has led to an uptick of research and development at Chinese firms and research centers.
FDA announces new Orphan Drug Modernization Plan to eliminate orphan designations backlog
On June 29, 2017, the U.S. Food and Drug Administration (FDA) announced a recent initiative for the eradication of the agency’s orphan disease designation request backlog. This backlog includes around 200 orphan drug designation requests. In addition to eliminating this backlog, the FDA has in place a new strategic plan of action for the prevention of a future requests backlog via the implementation of a 90-day response system.
To read the full articles for this issue of The CenterWatch Weekly, please click here for subscription information.