Michael Varrone回答:
so regarding the frequency and intensity of surprise inspections, I think Chinese companies will be affected if we take the administration's recent pronouncements as true and at the face value.
关于飞检频次和检查力度,如果我们将政府最近的声明当真并按字面理解,那么我认为中国公司将会受到影响。
As Chris said, I think ultimately the administration and the FDA want to level what is perceived as an unfair playing field,where companies in the United States have been routinely subjected to surprise inspections,where foreign companies, including Chinese companies are not.
正如Chris所说,我认为最终政府和FDA希望消除被认为是不公平的竞争环境,即美国公司经常受到飞检,而外国公司(包括中国公司)则没有。
And there is a big push.There's a skepticism in this administration of foreign companies in particular and there are certainly some in India and China.I believe there will be a focus on more frequent inspections in China and more surprise inspections.And ultimately the goal is compliance.
现任政府正大力推动此事,他们对外国公司,尤其是印度和中国的公司,持怀疑态度。我认为未来对中国公司的检查频次将增加,飞检也将增多。最终的目标是合规。
And FDA wants to see that companies are in compliance.And if not, they will act to do something.And I would expect them to heavily scrutinize going forward all companies,but particularly those in India and China,to make sure that they're following current good manufacturing practicesand in compliance with the laws of the Food and Drug Administration.
FDA希望看到公司合规。如果不合规,他们将采取行动。我预计他们未来会严格审查所有公司,尤其是印度和中国的公司,以确保它们遵守现行药品生产质量管理规范,并符合FDA的法律。
The second part of that question, how should we respond?but I think it's important to be prepared,to review your processes and procedures,and to make sure that the company is operating in compliance. and to review your risk management policies,and to make sure they're being implemented.
这个问题的第二部分,我们应该如何应对?但我认为重要的是要做好准备,审查你的流程和程序,确保公司合规运营。审查你的风险管理政策,并确保这些政策得到了实施。
I think it's very important because it's very possible, you will not know when FDA is showing up until shortly before or at that moment.
我认为这非常重要,因为很有可能直到FDA检查前不久或检查时你才知道FDA何时会来。
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