CFDA Issues New Drug Registration Draft

Recently, the CFDA published a new draft of the Provisions for Drug Registration for public comment. The new provisions updated the document from the 2007 version by changing Market Authorization Holder (MAH) regulations, improving the application approval process, and lessening provincial level FDAs’ authority in the approval and regulation process, among others. This update will increase the efficiency and quality of the CFDA’s clinical trial and drug registration approval process.