China FDA chief Bi updates press on quality crackdown

China FDA Commissioner Bi Jingquan said the regulator's aim is to follow President Xi Jinping's directives for the "most stringent" standards" for food, drug and device safety along with the "most severe punishment" for fraud.

CFDA Commissioner Bi Jingquan

The guiding words, Bi said at a rare and lengthy press conference in Beijing on Feb. 29, inform the CFDA's dealings with the public and companies in its push to reform the drug review and approval system and conduct sharper inspections on manufacturing and clinical trial work.

Bi said the approach was like a form of carrot and stick that will see the regulator as willing to discuss issues without pre-judgment, but also "to crackdown on all kinds of food and drug safety crimes."

Of particular note at the press conference was food safety, including comments on infant formula, a sensitive topic after the chemical melamine was found in local brands in 2007 and led to infant deaths and serious illness for many children. China executed the top food and drug regulator at the time, Zheng Xiaoyu, for his role in the scandal.

"Overall, the quality of dairy infant formula is reliable and safe to use," Bi said, noting a detailed inspection system in place that has seen the number of domestic companies in the space trimmed and imports also regularly tested.

But he said clearing a backlog of thousands of pending drug applications remains a work-in-progress, though at a faster pace and with a lower case load than what he cited as a peak of 32,000 applications without specifying the time period or current backlog figures.

"The drug evaluation backlog is indeed a most difficult task now facing the Food and Drug Administration," Bi said, adding that reforms announced last August are being implemented to speed up the process and hire more reviewers.

But he said "I cannot give you a timetable, I can only say that time is definitely shorter than before. The Center for Drug Evaluation reviews completed last year increased by 90% compared with 2014, the number of backlog cases now of (pending) drug (approvals has) dropped significantly."

Figures published late last month showed the CFDA approved 241 drugs in 2015, well below the previous two years and with the clear majority generics. It approved 470 drugs in 2014 and 374 in 2013. The breakdown for 2015 showed 24 biologic drugs approved of the 241 and 76 in traditional Chinese medicine.

Bi also touched on a decision to place a "moratorium on the implementation" of the Product Identification, Authentication and Tracking System known as PIATS to identify fake drugs that was designed by Hong Kong-listed Alibaba Health Information Technology, or Ali Health.

He suggested that technical and commercial issues were behind the decision and said that a review was underway to ensure any tracking system keeps the broad social goal of the effort above business aspects.

- here's the State Council release of the press conference (Chinese language)