Christopher Fanelli回答：

I think what we're seeing is a trend that started during the first Trump administration，and to an extent carried through the Biden administration，and has certainly started with the new Trump administration,which is scrutiny of overseas or foreign companies.

我认为我们目前看到的趋势，始于第一届特朗普政府时期，并在拜登政府期间有所延续，而现在随着新特朗普政府的上台，这个趋势更加明显，即对海外或外国公司进行严格审查。

Particularly, I would say now there's a significant amount of focus on life sciences companies located in China.And so in terms of what the impact that we're seeing already from a review standards perspective,

特别是，我认为现在非常关注位于中国的生命科学公司。因此，就我们已经从审评尺度角度看到的影响而言，

I wouldn't say necessarily that the Chinese companies are being held to a different review standard than US-based companies,but I would say is that they're getting a lot of scrutiny.

我不会说中国公司被要求遵守与美国本土公司不同的审评尺度，但我想说的是，他们正受到非常严格的审查。

And so I think this goes to the point of submissions need to be as strong as possible. You don't want to have mistakes.You don't want to have gaps in your data.

所以，我认为这说明提交的申报资料需要尽可能有力。你不希望出现错误。你不想数据存在缺口。

You want to be extremely confident in the package, the quality of the package,and the information that's contained in the package that you give to FDA.

你需要对提交给FDA的资料包、资料包的质量，以及资料包中包含的信息充满信心。

I think, what countermeasures are in place?I think the primary countermeasure is companies have to be ready for additional scrutiny.

有哪些应对措施？我认为主要的应对措施是，公司必须为额外的严格审查做好准备。

I think things that maybe FDA didn't pay as close attention to in the past，because maybe it wasn't a major issue for review, those are the types of things that may come up now；as being major review issues or potentially major GMP or quality issues.So I would say FDA is trying to raise the bar.

我认为，有些以前FDA可能不会太关注的事情，因为过去它们可能不是审评中的主要问题，但现在这些事情可能会成为主要审评问题或潜在的主要GMP或质量问题。所以我认为，FDA正在试图提高标准。

because if we start from the position of why is FDA doing this,it's primarily because it believes，that foreign manufacturers, including companies in China,have been held to a different standard.And so they're trying to raise the bar now. to level the playing field between the US and ex-US companies.

因为如果我们从FDA为什么这样做的角度出发，主要是因为它认为外国生产商，包括中国的公司，一直被要求遵守不同的标准。因此，他们现在试图提高标准，为美国公司和美国以外的公司提供公平的竞争环境。

And I know there's an inclination to feel that,FDA is targeting Chinese pharmaceutical companies.

我知道人们倾向于觉得,FDA正在针对中国药企。

And certainly, one of the reasons why we get involved as lawyers is there are legal limits.There are statutory limits on the types of actions that FDA can take based on the data that's in front of them. There are limits on what we call the Administrative Procedures Act

当然，我们作为律师介入的原因之一是因为存在法律限制。FDA根据其掌握的数据可以采取的行动类型是有成文法限制的。根据《行政程序法》的规定，

and FDA acting arbitrarily or capriciously，with regard to a review standard, a particular application,or treating a particular company in a way that is different despite the facts being the same.And so there are legal limits on FDA's authority to treat any particular company differently.

FDA对于特定申请的审评尺度，或在事实相同的情况下以不同方式对待特定公司等方面，不得武断或反复无常。因此，FDA在区别对待任何特定公司方面的权限是有法律限制的。

And these days, I would say FDA probably gets less discretion than it used to get for its decision-making.And so one of the things we, Mike and I, do as lawyers in this space a lotis to hold FDA accountable,is to work with our clients, whether they're US clients or ex-US clients,to make sure that FDA is acting according to its statute based on the information that they have in front of them.

而且如今，我认为FDA在决策方面拥有的自由裁量权可能比以前更少了。因此，Mike和我作为这个领域的律师，经常做的一件事就是监督FDA的责任，与我们的客户（无论是美国客户还是美国以外的客户）合作，确保FDA根据其掌握的信息按照成文法行事。

Michael Varrone回答：

And I absolutely agree with Chris and everything he said.

我完全同意Chris的观点。

I think that COVID highlighted the supply chain for various parties in the United States,and made it clear to them that the supply chain needed to be bolstered.

我认为COVID凸显了美国各方在供应链方面的问题，并让他们清楚地认识到，供应链需要得到加强。

And the Trump administration, the Biden administration,and now the Trump administration again,has a focus on shoring up the supply chain for the United States.

特朗普政府、拜登政府，以及现在重新上任的特朗普政府，都将重点放在了加强美国的供应链上。

And there's a lot of disagreement in American politics,but one thing that the administration and Congress,and both parties in Congress have tended to agree on,is that manufacturing issues are a priority,And there's going to be more of a focus on that.

美国政治中存在许多分歧，但有一件事是政府和国会，以及国会中的两党都倾向于认同的，那就是生产问题是优先事项。并且未来将更加关注这一点。

Now, the question is how the government is actually,going to implement any sort of strategy to address that.And there's still a lot that remains to be seen as far as what Chinese pharmaceutical companies have already felt.

现在的问题是，政府将如何真正实施任何策略来解决这一问题。至于中国药企目前已经感受到的变化，还有很多有待观察。

I'm not sure that there's been a significant impact yet,because there's still a lot of change that's going on.And what the actual strategies that are implemented mostly remains to be seen.

我不确定是否已经产生了重大影响，因为仍然有许多变化正在发生。并且实际实施的策略大部分还有待观察。

But I think what Chris said is absolutely true.

但我认为Chris所说的完全正确。

There's been a thought over the recent years,that foreign companies, including Chinese pharmaceutical companies,have had an easier time as far as inspections go than their American counterparts. So that will be more of a focus going forward for sure.

近年来有一种观点认为，外国公司，包括中国药企，在面对检查时比他们的美国同行要轻松一些。因此，这肯定会成为未来的重点。

And then as far as review standards,I agree with Chris.I don't think those will change,but there will be more scrutiny, I believe.I believe there will be more scrutiny in the application process for all companies, actually,for both American and Chinese companies and other companies,as far as whether the data is there to support the application.But in particular, I think there will be more scrutiny for Chinese pharmaceutical companies.

然后在审评尺度方面，我同意Chris的观点。我认为这些不会改变，但我相信审查会更加严格。我相信所有公司在申请过程中都会面临更严格的审查，无论是美国公司、中国公司还是其他公司，尤其是在数据是否足以支持申请方面。但特别是，我认为对中国药企的审查会更严。

So it's important to have that information, robust information,and all of the information that's necessary to support the application, particular application.

因此，拥有稳健的信息,以及所有支持特定申请所需的信息非常重要。