China FDA Cracks Down on Quality Issues with Drug Rejections

Source: Channel News Asia

Nov 13, 2015

The China Food and Drug Administration has taken a tougher stance on drug quality by rejecting applications for 11 drugs with inadequate or suspect clinical data.

The CFDA has withheld approvals from eight Chinese companies making generic drugs for heart problems, schizophrenia, pain, infections and other diseases.

A series of on-site inspections by the agency in October revealed that clinical trial data in applications from the eight companies were incorrect or incomplete. The eight companies included: Hainan Pharmaceutical, Zhejiang Huahai Pharmaceutical, Hebei Pharmaceutical, Qingdao Bai Yang Pharmaceutical, Zhejiang Angli Kang Pharmaceutical, Hainan Kang Chi Pharmaceutical, Guangdong Pharmaceutical and Shandong Da Yinhai.

Read the Channel News Asia press release