China FDA cracks down on pharmas in quality control effort
- The China Food and Drug Administration (CFDA) announced it has rejected 11 drug applications from eight companies as a result of clinical-trial data deficiencies. Back in July, the CFDA began a drug-quality crackdown leading up to onsite inspections in the early fall.
- China is in the midst of a major health reform effort.
- Jack Hu, an analyst at Deutsche Bank, has said that although this additional scrutiny represents a near-term challenge for the Chinese pharma industry, oversight could definitely benefit companies with higher standards, according to a report from Reuters.
The Chinese pharmaceutical market is a serious contender on the world stage—and the CDFA wants to make sure that quality issues do not become a concern as they have in India. This year, the Chinese pharma market is expected to have roughly $63 billion in sales—more than in Brazil, Russia, and India combined.
Beyond the sheer size of the Chinese populace, an aging population and a growing middle class have been key drivers of industry growth.
As Mr. Hu indicated, pharma companies with high-quality standards, such as Sino Biopharmaceutical, Shanghai Fosun and 3SBio, stand to benefit. The eight companies receiving submission rejections are 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. If they can turn things around, they could enjoy the upside of a rapidly growing market.