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出自识林

2015-03-24 FDA Voice

Howard Sklamberg 和 Cynthia Schnedar
FDA Voice 2015年3月24日

Cynthia Schnedar, J.D., FDA 药品审评与研究中心合规办公室主任

Howard Sklamberg, J.D., FDA全球监管活动与政策副局长

上周，当我们穿行在旧德里，买卖各种香料和纱丽的游客和店主充斥着这个繁华而古老城市的街道，我们被这个城市的辉煌以及献给世界的财富深深打动。

关于处方药的确如此。印度是美国重要的仿制药出口商。随着越来越多的仿制药大量减少患者和美国医保体系的费用，美国民众从仿制药获益极大。印度制药明星的崛起是我们印度之行之所以如此重要的原因之一。

在这儿，我们有机会见到我们在印度政府的监管同行，以及总部在这里或在这个国家有设施的药品生产企业。不用多说，我们正学到很多。

一些印度企业曝露出的与仿制药质量相关的挑战已经不是什么秘密。有些人问我们FDA是否“挑出”印度加强检查。我们只是回应，不论是世界上的哪个国家，出口到美国的增加导致检查的增加。FDA检查保证那些希望出口药品到美国的企业，其生产的药品符合FDA标准并且具有患者和消费者需要和应得的品质。

上周，FDA Howard Sklamberg和Cynthia Schnedar与印度药品协会参加关于药品质量的小组讨论

我们已经很高兴的听到，专注药品质量是我们会见的印度监管机构和药品生产商的共同目标。他们明白，FDA有兴趣帮助建立一个全球质量网络，不论这个药是在霍博肯（美国新泽西州东北部城市）还是在海得拉巴（印度城市）生产，如果药品在美国使用，那么我们将使用相同的标准和检查水平审查药品、生产方法和生产环境。

顺便说一句，这种审查并不一定要得到负面的结果。与药品生产相关的检查一直是此行的核心讨论点，我们带来了广受欢迎的，尤其受制药业欢迎的新闻。我们分享了我们提出的创建新设施检查方法的计划，其中一条是不仅会注意问题，同时也允许检查员记录企业质量管理体系超越法规符合性要求的地方。简单地说，检查不仅仅给出大棒，也给胡萝卜。

那么什么是胡萝卜？这些发现可以用于影响我们对特定设施的检查频率，甚至可能支持有关批准后生产变更的监管灵活性。这些决定的作出，依赖于能够证明一所特定设施的生产问题风险是最小的数据。

上周，FDA Howard Sklamberg和Cynthia Schnedar与印度制药企业CEO会面讨论药品质量

我们经常说我们不能通过检查绝对确保药品质量。此次行程中我们的很多讨论都集中在企业提升其自身“质量文化”的重要性上。为此，我们了解到我们可以采取措施帮助企业成功。例如，我们将试行用于进一步规范检查的新的调查问卷，以期一致地获得可以支持精确量度质量的数据。我们相信，通过这样改善检查过程，未来定义质量的“量度”将得到世界各地生产商的理解和渴求。

当然，强制执法一直是并将继续是我们保障药品质量计划的重要组成部分。当企业不向我们提交准确的数据时，强制执法是特别合适的工具。FDA依靠信息来完成工作，错误的信息意味着我们不能确保企业生产的药品质量。

在与印度监管机构和企业领导谈过之后，我们已经清楚，印度想要成为致力于生产最高质量药品的全球共同体的一部分。通过研讨会和联合检查，我们将继续与印度政府合作，以提高我们检查过程的认识和理解。对于我们在这里见到的企业领导，我们承诺将继续收集，针对我们应如何帮助改善有关质量问题并激励企业这样做的反馈。

印度是药品生产国星系中的一颗耀眼的明星。正如一位印度官员雄辩的告诉我们，我们有着共同的“银河系”。并且，我们高兴地补充，在那银河系中最耀眼的一颗是我们对药品质量全球体系的共同承诺。

编译：识林-椒 2015-03-24
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From New Jersey to New Delhi, a global focus on quality
Posted on March 24, 2015 by FDA Voice
By: Howard Sklamberg and Cynthia Schnedar

As we walked through the bustling, ancient city streets of Old Delhi last week, teeming with tourists and shop keepers selling spices and saris, we were struck by how resplendent this country is, and just how much it offers the world.

This is certainly true about prescription drugs. India is a significant exporter of generic drugs to the United States. The American people benefit tremendously from generic drugs, as more and more generic medications reduce costs for patients, and the American healthcare system. The rise of India’s pharmaceutical star is one of the reasons why our trip to India is so important.

While here, we have had a chance to meet with our regulatory counterparts in the Indian government, as well as the drug manufacturers that are either based here, or who have facilities in the country. Needless to say, we are learning a great deal.

It's no secret there have been challenges associated with the quality of generic drugs coming out of some facilities in India. Some people have asked us here if the FDA is “singling out” India for increased inspections. We simply reply that increased exports to the U.S. result in increased inspection, no matter where you are in the world. FDA inspections ensure that when a firm wants to export drugs to the United States, the drugs meet FDA standards and will be of the quality patients and consumers want and deserve.

And we've been happy to hear that this focus on quality is, in fact, a shared goal, held by both the Indian — and India-based — regulators and pharmaceutical manufacturers with whom we’ve met. They understand what we mean when we tell them the FDA is interested in helping to build a global network of quality; that it doesn’t matter whether a drug is made in Hoboken or Hyderabad, if it is intended for use in the United States, the drug, and the way and under what conditions it’s produced, will be reviewed using the same standards and levels of scrutiny.

That scrutiny, by the way, doesn’t always have to have negative results. The inspections associated with drug production have been a central discussion point on this trip, and we’ve brought news that has been well-received, especially by the drug industry. We shared our proposed plan to create a new approach to facility inspections, one that will not only note problems, but will also allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance. To put it simply: the inspections can yield also carrots, and not just sticks.

So what are the carrots? These findings could be used to influence the frequency of our inspection of a particular facility, and possibly even support regulatory flexibility around post-approval manufacturing changes. These kinds of decisions would be anchored by data that proves that the risks of manufacturing problems in a certain facility are minimal.

We have often said we cannot inspect our way to absolute drug quality. Many of our discussions on this trip have focused on the importance of firms enhancing their own “quality cultures.” And, to that end, we know there are initiatives we can take to help them succeed. For example, we will be piloting a new questionnaire that could be used to further standardize inspections, with the goal of uniformly harvesting the kind of data that supports accurate measures of quality. We believe that by improving the inspection process in this way, future “metrics” that define quality will be understood and aspired to by manufacturers — no matter where they are in the world.

Of course, enforcement has been, and will continue to be, an important part of our program to ensure drug quality. Enforcement is a particularly appropriate tool when a firm does not submit accurate data to us. FDA relies on information to do its job, and faulty information means that we cannot ensure the quality of the drugs that the firm produces.

It is already clear to us, after speaking with regulators and industry leaders here, that India intends to be part of that global community that is committed to producing the highest quality of drugs possible. Through workshops and joint inspections, we continue to work with the Indian government to raise awareness and understanding of our inspections processes. And to the industry leaders we have met with here, we have pledged to continue to collect their feedback on how we might be able to help them improve regarding quality issues, and to incentivize them to do so.

India has a significant spot in the constellation of drug-producing nations. As one Indian official so eloquently said to us, we have “a galaxy” in common. And, we are happy to add, that the brightest star in that galaxy may just be our shared commitment to a global system of drug quality.

Howard Sklamberg is FDA's Deputy Commissioner for Global Regulatory Operations and Policy
Cynthia Schnedar, J.D., is Director of the Office of Compliance at FDA's Center for Drug Evaluation and Research