Regulatory Focus™ > News Articles > Consolidation of China's SFDA Grants Agency More Prestige, Power

Consolidation of China's SFDA Grants Agency More Prestige, Power

Posted 11 March 2013 | By Alexander Gaffney, RAC

China's State Food and Drug Administration (SFDA) will soon be revamped and given additional authority under a planned governmental reorganization that will see various regulatory oversight agencies consolidated under its authority, reports various news outlets.

Need for Change: A Crisis of Confidence

News of the reorganization broke last week in a report by the South China Morning Post, which wrote that the National People's Congress (NPC)-the last under outgoing Prime Minister Wen Jiabao-was considering changes in the wake of numerous quality scandals involving food and drug products.

One scandal in particular, as reported by Pharmalot'sEd Silverman last year, was the case of so-called "gutter oil"-recycled cooking oil-used in the manufacture of antibiotics in the country instead of the proper soybean oil used to make 7-aminophalosporinic acid (7-ACA).

The larger issue, the SCMP wrote, is that right now regulatory authority in the country is highly fragmented as the result of political struggles and scandals.

"When founded in 2003, [SFDA] was a ministerial-level agency directly under the State Council and meant to have greater power," SCMPwrote. "But it was downgraded and affiliated to the Ministry of Health in 2008 after a series of corruption scandals involving several SFDA officials. These included its head, Zheng Xiaoyu , who was convicted and executed for taking bribes and dereliction of duty."

In the meantime, however, further scandals have continued to erupt, threatening not only Chinese consumers, but consumers abroad as well. The 2008 heparin scandal in the US, in which contaminated supplies thought to have originated in China made their way into the US, killing more than 80 people, is a prime example of the latter.

"Consumer confidence in the mainland's food and drug industry has been shattered," SCMP noted.


Now, in a bid to restore that confidence, the NPC is moving to consolidate power in a newly-endowed SFDA. Under the new plans, China Daily reports that SFDA would be elevated to a ministerial-level agency. The changes would mostly affect food regulation in the country, with the State Council's Food Safety Office, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the State Administration for Industry and Commerce (SAIC)-and their staff-all coming under SFDA.

But if the agency's food authority got a massive boost, reports don't mention any changes to the way SFDA regulates pharmaceutical or medical device products-something mentioned as possible by the SCMP last week when they noted the NPC could focus solely on the regulation of food products.

However, the additional authority gained by the agency by way of its promotion within China's government to a ministerial agency could boost its ability to argue for additional resources and authority to go after counterfeiters and other quality concerns that have plagued the country as of late. A boost in its regulatory capacity would be a welcome change for industry, which has long complained about the agency's lengthy and sometimes confusing regulatory processes.


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