食品和药物丑闻之后，中国的监管机构得到改造

StephenW

After food and drug scandals, China's regulator gets a makeover

    Felix Cheung   

    Nature Medicine    19,    513    (2013)
    doi:10.1038/nm0513-513a

Published online
    07 May 2013


HONG KONG — The State Food and Drug Administration (SFDA) of China was no stranger to shady dealings. Six years ago, former director Xiaoyu Zheng was convicted and executed for reportedly taking bribes from eight pharmaceutical firms in exchange for approving unsafe medicines. Several other top officials were fired for corruption, too. So, when a construction crew arrived at the SFDA headquarters in Beijing in the early morning hours of 22 March with no advance public notice, suspicions were aroused. However, nothing was afoul. The workers were there simply to put up a new aluminum doorplate outside the gate. It read: China Food and Drug Administration (CFDA).

The name change came in response to numerous quality scandals involving food and drug products in recent years—for example, the contamination of heparin in 2008 and the use of 'gutter oil' to make antibiotics in 2012. Officials now hope that the much-anticipated organizational restructuring will improve food and drug quality, strengthen drug regulations and close existing loopholes.

At the very least, the rebranding seems to have raised the agency's stature among drugmakers in China. The new name “signifies the consolidation and revitalization of the management system,” says a spokesperson from a major international pharmaceutical company with offices in Beijing and Shanghai, who spoke to Nature Medicine on condition of anonymity. “As a result, the drug licensing process will become better regulated and streamlined.”

The CFDA stems from the merger of two major regulatory authorities: the SFDA and the Food Safety Commission Office (FSCO), with additional duties handed over from other government agencies as well. For example, the CFDA will oversee both food production and food distribution. These tasks had been overseen by the General Administration of Quality Supervision, Inspection and Quarantine and the State Administration for Industry and Commerce, respectively. Previously, approximately ten government agencies regulated food and drug safety in some way, with many responsibilities overlapping.



The CFDA has also become a ministerial-level agency, which means it will report directly to the State Council, the highest executive branch of the Chinese government. It will have broader authority to implement and enforce regulations than the former SDFA, which experts hope will lead to a more streamlined and efficient registration process for drugs and medical devices in the country.
New name, new leadership

As part of the renaming, Yong Zhang, the former director of the FSCO, was appointed as the new director of the CFDA. He replaces Li Yin, the last director of the SFDA, who was only appointed in February 2012.

Since the CFDA started operations in March, Zhang has already held multiple meetings with high-level officials from the former SFDA and FSCO to discuss the redeployment of roles and duties. According to a CFDA statement, his main priorities in the short term are to strengthen existing safety regulations and prevent bribery and extortion at the new agency. In the long term, Zhang intends to streamline service delivery, strengthen safety regulations and prevent bribery and extortion.

The ongoing outbreak of H7N9 influenza in eastern China has provided a first test of the new agency. On 6 April—just two weeks into the CFDA's existence—the agency granted 'fast track' approval to the intravenous antiviral drug peramivir, an inhibitor of the neuraminidase enzyme that helps the virus emerge from host cells.

StephenW

香港 - 国家食品药品监督管理局（SFDA）对中国并不陌生，见不得人的勾当。六年前，前任董事郑小玉被定罪和执行据说从8个制药公司的贿赂，以换取批准不安全药品。其他几个被解雇的高层官员腐败，也。所以，当建筑队来到国家食品药品监督管理局的总部设在北京，在3月22日清晨，在没有事先公告，产生怀疑。然而，什么也没有发生冲突。工人只是提出了一个新的铝合金门牌的大门之外。上面写着：中国食品和药物管理局（CFDA）。

此次更名是近年来涉及食品和药物产品，例如在2008年，肝素污染和“阴沟油”的使用，使抗生素在2012年众多的质量丑闻。官员现在希望万众瞩目的组织结构调整将提高食品药品质量，加强药品法规和关闭存在的漏洞。

最起码，品牌重塑似乎已经提出了该机构的身材在中国的制药公司之间。新名称“表示整顿和振兴的管理体制，说：”一个主要的国际制药公司的一位发言人在北京和上海设有办事处，谁不愿透露姓名的自然医学说话。 “因此，药品生产，经营许可证的过程将变得更好的规范和精简。”

CFDA的源于两个主要监管机构：国家食品药品监督管理局，食品安全委员会办公室（FSCO），的，额外的职责交给其他政府机构，以及合并。例如，CFDA将监督食品生产和食品配送。这些任务已分别由质量监督检验检疫总局和国家工商行政管理总局，工商总局，监督。此前，约1​​0个政府部门监管食品和药品安全，在某种程度上，许多职责重叠。


CFDA也已成为一个部级机构，这意味着将直接汇报给国务院，中国政府的最高行政部门。这将有更广泛的权力，比前SDFA，希望哪位高手会导致一个更精简和高效的登记过程中药品和医疗器械在全国落实和执行法规。
新的名字，新的领导班子;

重命名的一部分，FSCO前董事张勇，被任命为新董事的CFDA。他将接替李寅，最后国家食品药品监督管理局，于2012年2月才被任命董事。

由于CFDA三月开始运作，张已经从原国家食品药品监督管理局和FSCO与高层官员举行了多次会议讨论角色和职责的重新调配。根据的CFDA语句，在短期内他的主要优先事项是在新的机构，以加强现有的安全法规和预防贿赂和勒索。从长远来看，张拟简化服务交付，加强安全法规，防止贿赂和勒索。

H7N9流感的持续爆发，在中国东部地区提供了一个新机构的第一次测试。在6月短短两周到了CFDA的存在机构授予'快车道'批准静脉抗病毒药物帕拉米韦的神经氨酸苷酶抑制剂，帮助病毒从宿主细胞出现。

StephenW

杏林老人 发表于 2013-5-9 15:53
我不喜欢介入政治。

我不喜欢不介入政治的。