CFDA Issues New Drug/Clinical Trial Approval Regulations

The CFDA has issued new policies to reduce the very long waiting times for approvals -- both for clinical trial and marketing approvals. According to a recent Ropes & Gray internet posting, the new rules: 1) expand the categories of new drugs that qualify for fast-track approval; 2) simplify the clinical trial approval procedure; 3) allow innovative companies to file for approval without owning their own drug manufacturing facility; and 4) classify drugs that are approved outside of China as generics for China approval.