China's Food and Drug Administration is cracking down on drugmakers, rejecting 11 applications for generic treatments in a move widely seen as an effort to bolster confidence in the country's biopharma industry by demanding that players meet higher standards.
The CFDA told drugmakers last summer that they should undertake their own inquiries into their trial data following a slate of voluntary recalls, according to a report from Reuters. Then at the end of October the agency launched its own probe, doing on-site inspections that led to the rejections.
"The CFDA seems very, very determined on this quality issue and that could change the Chinese pharmaceutical industry in a big way," a senior industry exec told Reuters.
The country overall has been plagued by a reputation for shoddy manufacturing practices, a reputation that has threatened a biopharma industry that has been developing business ties around Asia and the world.
Deutsche Bank analyst Jack Hu told the news service that the CFDA's move would likely benefit companies with a solid reputation for high standards, including Sino Biopharmaceutical, Shanghai Fosun and 3SBio.
- here's the story from Reuters