FDA将增加1000万美金来加大对中国的监督检查力度！

GmpForEver

FDA Fact Sheet: Increasing FDA Capacity in ChinaFundamental changes in our economic and security landscape require the U.S. Food and Drug Administration (FDA) to change its regulatory approaches to promote and protect the health of the American people. Over the past decade, the global economy has been shaped by a number of forces, including rapidly increasing flows of goods into the United States. It is expected that eventually, the growth in imports of FDA-regulated products will outpace the growth of domestic production. According to some estimates, imports of FDA-regulated products may triple between 2007 and 2015, corresponding to a 15 percent annual growth rate. Companies will not only be producing more FDA-regulated products abroad, but these products will follow complex paths through multi-step supply chains to reach the U.S.
Nowhere is this dynamic more evident than in U.S. trade with China. From October 1, 2006 to September 30, 2011 – during the Fiscal Years (FYs) 2007-2011 – the total number of shipments of FDA-regulated products from China increased approximately from 1.3 million to 2.1 million. Of the 2.1 million entry lines arriving in FY 2011, 30 percent were drugs and devices, and 12 percent were human food products.
New Approach and Resources
To protect American consumers by ensuring that these rapidly increasing Chinese imports are safe, effective, and comply with U.S. science-based standards, FDA must adopt a new regulatory approach: it must increase its capacity for inspecting and analyzing Chinese products before they are shipped to the United States.
In his budget proposal for FY 2013, the President supports this approach by adding $10 million to FDA’s budget base. If appropriated by Congress, these new resources will strengthen the protection of American consumers and patients in the following ways:

• FDA will strengthen its inspection and analytical capabilities by increasing its presence in China by sixteen inspectors and by adding three U.S.-based China analysts.
• FDA will broaden the range of its inspections. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, FDA will inspect sites of clinical trials and conduct follow-up inspections to ensure that firms continue to produce and manufacture food and medical products under safe conditions, and that they apply sound production practices.
• These increased activities will offer unique opportunities for engagement with Chinese regulatory counterparts. Direct observation of FDA inspections can bolster Chinese regulators’ understanding of FDA’s requirements and processes and strengthen China’s inspectional capacity.
• FDA can also support Chinese regulators’ knowledge of U.S. safety standards through workshops and seminars. These opportunities help facilitate dialogue and encourage scientific exchange on the critical role of inspections in improving the safety and quality of food and medical products.
  

Risk Analytics for Better Decisions
To best protect Americans, FDA must know as much as possible about emerging public-health trends and risks. By collecting and evaluating information from multiple sources, FDA can identify possible threats and conduct sophisticated risk analyses. The development of a U.S.-based team to analyze assembled data and evaluate risks would also complement assessments and analyses of FDA’s in-country staff.
The proposed budget increase will enable the agency to use informatics tools such as trend analysis, predictive modeling, and geospatial mapping to sharpen FDA’s understanding of possible public-health risks. With the help of risk analytics, FDA can better position itself to address these risks and trends. Better use of data will enable FDA to strengthen its systems in several key areas, including implementation of science-based, harmonized standards. The ultimate goal is to detect and address risks through more preventive, risk-based approaches before they can result in harm to U.S. consumers.
The growing demand by American consumers for Chinese food and medical products requires that FDA develop deeper knowledge and greater expertise in the regulation of these products. Over time, this familiarity will enhance mutual collaboration and enable FDA to increasingly rely on information and actions of its regulatory counterparts. The resulting increase in the safety and quality of Chinese imports will help protect and promote the health of Americans.

巴西木

FDA才增加1000美金啊

hongwei2000

巴西木 发表于 2013-4-19 15:57
FDA才增加1000美金啊

没看内容，但应该是每个人吧

hongwei2000

$10 million to FDA’s budget base
楼主落个万

残伤

学习学习

残伤

学习学习

yuansoul

hongwei2000 发表于 2013-4-19 16:00
$10 million to FDA’s budget base
楼主落个万

明显是没有双人复核造成的翻译差异

GmpForEver

巴西木 发表于 2013-4-19 15:57
FDA才增加1000美金啊

呵呵，丢了个“万”字

GmpForEver

yuansoul 发表于 2013-4-19 16:07
明显是没有双人复核造成的翻译差异

双人复核真的很重要

GmpForEver

hongwei2000 发表于 2013-4-19 16:00
$10 million to FDA’s budget base
楼主落个万

谢谢

yuansoul

粗翻：

FDA简报:增加FDA在考虑中国产原料控制能力变化实在是逆天，在我们的经济和安全领域对米国人打击风险太高，要求美国食品和药物管理局(FDA)改变其监管办法,促进和保护健康的米国人。在过去的十年里,全球经济已经形成了一个数量的部队,包括迅速增长的流动的货物到米国。预计最终,增长将超过相关产品的国内生产的增长。根据一些历史数据估计,fda相关产品的进口可能从2007年到2015年之间,处于15%的年增长率。很多山寨公司，不仅将生产更多山寨产品，本来也没打算卖给咱们。但这些产品将，通过复杂路径，通过国际倒爷，通过多级供应链到达米国。
从2006年10月1日到2011年9月30日——在财政年2007 - 2011的总数上分析，中国相关产品出货量增加大约从130万/年到210万/年。210万/年进入量，整合计算2011财政年度预算,30%是药品和设备,12%是人类食品（其实还有动物饲料呢）。
通过新方法（民族企业保护手段）和资源保护（借刀杀人）美国的消费者,确保这些迅速增加的中国进口物品是安全的,有效的,符合美国FDA标准,必须采用科学的一种新的管理方法:那就是批批检验、桶桶检验。
在本国的预算提案，2013财政年度,总统（奥斑马先生）支持这种方法，通过增加1000万美元的预算预算。美国食品及药物管理局，如果由国会拨款（更好，这样中午可以吃汉堡了，要不钱不够花）,这些新资源将加强保护美国的消费者和患者在以下方面: FDA将加强检查和分析能力，通过增加其在中国的业务（潜伏的间谍），十六个检查员和很多设备来保证。

syhorchid

谢谢分享