FDA增加1000万预算用于中国检查，中国企业该如何面对？

一沙一叶

The U.S. Food and Drug Administration (FDA) signed two Implementing Arrangements (IAs) with its Chinese counterparts to create a framework for expanded FDA staffing in China. The documents, signed with China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and China’s Food and Drug Administration (CFDA), outline commitments from FDA and AQSIQ regarding inspections of food facilities, and commitments from FDA and CFDA regarding  inspections of drug facilities.
美国食品药品管理局曾经就在中国增加FDA员工的事情与中方签了两份约定。 这两份约定，分别是与国家质量监督检验检疫总局签订的关于食品企业的检查，与CFDA签订的关于药厂检查的约定。
The IAs spell out commitments in the following areas:
这两份约定在以下方面做了承诺：
• Scope of inspections: the IAs make clear FDA’s intent to conduct inspections in Chinese facilities that manufacture or process food or drugs for export to the United States;
检查的范围：约定明确指出FDA将要对生产或加工食物或药品用于出口美国的中国企业进行检查。
• Planning: FDA commits, in most cases, to provide advance notice to Chinese authorities regarding its inspections;
计划：FDA承诺，在多数情况下，要提前通知中国官方关于检查的内容；
• Intent: these documents make clear that FDA’s intent in its inspections is to determine whether Chinese firms comply with FDA’s requirements;
目的：这些文件明确FDA进行检查的目的就是为了确认中国的公司是否符合美国的要求；
• Information sharing: the IAs create mechanisms for information sharing, including sharing of inspectional reports, to the extent permitted by law;
信息共享：约定创建了信息共享的机制，包括分享检查报告，在法律允许的程度；
• Joint efforts in inspectional work: the IAs outline a framework through which Chinese inspectors will be able to observe FDA inspectors during inspections in China;
在检查工作方面共同努力：约定概述了一个合作框架，即FDA检查官在中国进行检查的时候中国检查官能够进行观察。
• Public health hazards: FDA and its Chinese counterparts commit to notify one another regarding inspectional findings that might constitute potential hazards to health; and
公共健康风险：FDA和中方承诺如果在检查中发现可能对公众健康造成潜在风险的问题时要互相通知。
• Technical collaboration, leveraging information: FDA, AQSIQ and CFDA commit in these documents to continue to strengthen their collaboration on technical issues, and to look for opportunities to leverage information from one another’s regulatory systems.
技术合作和信息交流：FDA、AQSIQ和CFDA在这些文件中承诺将会继续加强技术方面的合作，并寻找机会加强双方法规系统的交流；
The IAs follow a bilateral agreement made between the United States and China during Vice President Biden’s December 2013 visit to Beijing, in which China pledged to promote bilateral communication and cooperation with respect to medical products, food and feed, as well as to issue visas for increased numbers of FDA staff in China.
这些约定是在美国副总统拜登在2013年12月访华达成了中美双方双边协议后进行的，在双边协议中，中方承诺在医药产品、食品、饲料方面加强双边沟通和合作，也要给FDA在中国增加的工作人员发放签证。
Through the China Safety Initiative, FDA received $10 million in increased funding for staffing in China. This funding supports the addition of 10 drug inspectors and seven food inspectors to FDA’s in-country presence in China, and will move FDA’s overall staffing in China to 26 U.S. direct hires.
通过这项中国安全倡议，FDA获得了1000万美元用于增加在中国工作人员的预算。这些钱用于支持额外增加10名药品检查官和7名食品检察官在中国境内工作，并将美国直接雇佣在中国工作的员工增加到26人。
Background:背景：
In 2007, HHS entered into two agreements with the Chinese government.
在2007年，HHS与中国政府讨论两个协议。
1. The first is between HHS and AQSIQ of the People’s Republic of China. It established a means of cooperation between FDA and AQSIQ on food and feed safety.
1. 首先是HHS与AQSIQ之间的。它确立了FDA和AQSIQ在食品和饲料安全方面的合作方式。
2. The second is between HHS and CFDA (formerly, the State Food and Drug Administration, or SFDA). Like the first agreement, this established a mechanism for regulatory cooperation, but for the safety of drugs and medical devices.
2.第二是HHS和CFDA之间的（正式的，国家食品药品监督管理总局，或SFDA）。类似第一个协议，确立了法规合作机制，而不是药品和医疗器械安全。
Since these agreements were signed, FDA’s international work and foreign presence has grown, and has become increasingly important in light of globalization.Under the terms of the agreement reached during Vice President Biden’s visit to Beijing in December 2013, FDA agreed to work with AQSIQ and CFDA to frame the expansion of its staffing in China.
在这些协议签订后，FDA的国际化工作和在国外的出现逐渐增加，而且全球化方面越来越重要。根据副总统拜登在2013年12月访问北京达成的协议，FDA同意与AQSIQ和CFDA合作来扩充在中国的员工。
FDA is working to significantly increase the number of overseas inspections it conducts annually, including in China.
FDA正在努力大幅增加每年进行的海外检查的数量，包括在中国。

http://www.fda.gov/NewsEvents/Newsroom/FactSheets/default.htm

巴西木

其实对中国CFDA的工作起到了促进作用，预算多多益善

davidcone

同意楼上的说法。有很大的促进作用。

曹小芬爱疯叮

同意一楼。。

syhorchid

也不尽然

彩虹

严格起来了

孙艳红

促进制药行业GMP水平提升，保证人民用药安全。

yyylggglll

好呀，中国的有些老板太无良了。

河西智叟

还可以，只有1000万，如果是1个亿，那就说明天朝的东西低价劣质了。。

彩虹

看下

土豆王

了解一下！

皇后

2013白等总统来的时候，新闻提过

三尺之冰

希望能借此提高中国制药的水平

benbene

应该是件好事

玻璃杯

出口洗牌？
之前老实的企业，这算好消息了

leehwadong

希望对国内药物生产质量起到促进作用。

江寒315

最好的应对办法是提升自己的造假水平让别人发现不了，要么就老老实实。
应对，有什么好应对的，
自己做出的事情要有所担当。

天上没有月亮

来吧，我喜欢

gproe

好好学习天天向上