China is cracking down on its pharmaceuticals industry by denying applications for 11 medicines with inadequate or suspect clinical data.
The CFDA posted a statement on its website saying that the move affected eight Chinese firms that make generic drugs for schizophrenia, heart problems, infections, pain and other health issues.
The crackdown comes in the wake of a July call for manufacturers to conduct their own internal investigations into trial data, which already has led to numerous voluntary recalls. In October, the CFDA conducted a series of on-site inspections and discovered that clinical trial data in applications from eight companies for 11 drug products either were incomplete or incorrect.
The quality of the medicines that China produces is a growing concern for Beijing, which is moving forward with a new healthcare reform program, and for foreign nations that rely on India and China for pharmaceutical ingredients as well as finished drugs. The generic drugs industry in India has encountered a number of high-profile quality problems with the FDA in recent years.
