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2014-11-22 FDA Voice

中国之行：强化合作关系，保护公众健康
Margaret A. Hamburg, M.D.
FDA Voice 2014年11月21日

现在我即将为五天充实的中国之行画上圆满句号，中国是一个经济飞速发展、具有强烈吸引力的国度，同时，这个国家又对美国人所消费的产品有着日益深远的影响。事实上，我此行的重要原因之一就是美国食品药品管理局（FDA）和中国的对应机构之间十分重要和不断强化的合作关系，确保在我们两国间交易的大量食品和医药产品的安全。

向美国出口产品的200余个国家当中，中国位列出口榜首（以美元计）。中国是第六大食品、药品及生物制品的出口国。全球在FDA注册的药品生产设施中，仅美国多于中国。并且中国的这一数字正在持续攀升。2007到2013年间，受FDA监管的产品中，中国向美国的年出口量几乎翻了两番， 2013年向美国进口的产品达到520万进口线^注（出货部分） 。

确保这些以美国为目的地的受FDA监管产品的安全与质量，是一个重大挑战。为完成这一重任，FDA自身完成了转型—从主要关注在美国生产产品的国内机构，到一个应对众多全球化挑战的真正意义上的全球性机构。

在这一领域的众多工作中，很重要的一个组成部分就是FDA在所有主要的出口地区建立由FDA专家常驻的外派机构，包括中国。目前我们有13位FDA职员常驻中国，主要在北京。他们的主要工作是帮助确保从中国出口的食品和医药产品符合我们的标准。通过对FDA在中国的现场检查提供大力支持，增进FDA与中国监管机构关系，与产业界和其他利益攸关方协作，向有关各方提供重要信息和技术支持，对可能影响出口至美国的FDA监管产品安全性的趋势与相关事件进行分析，FDA中国办公室通过上述这些方式积极开展工作。

考虑到中美之间的贸易量，我们正在努力派超过3倍于现驻人员的美国职员到中国来。派驻更多的FDA专家来到中国能够显著增加FDA在中国这样一个充满活力和战略意义的国家的检查次数，同时也能更有效地与我们在中国的同仁合作。如此大数目地增加职员也能够使得FDA增强培训工作，促进与中国监管机构、产业界和其他方面的合作。

这周，我们与中国国家食品药品监督管理总局签订的《实施安排》，使我们在增进双方关系上又迈出了重要一步。我们期望在接下来的几周能同中国国家质量监督检验检疫总局(AQSIQ)也签订类似的协议。2007年，同样是与这两个机构签订的协议文件，帮助我们制定了在中国开展检查工作的框架，同时建立了现场检查的合作机制。

FDA同致力于与其他利益攸关方一同，创造可持续的模式，来培养未来的监管科学与质量领导者。在中国，我们与北京大学这样一所以培养中国领导者与思想者而著名的高校，创办了一项世界水准的研究生项目，即北京大学国际药物工程管理（IPEM）硕士。

与北京大学的合作始于2005年，当时仅有两门有关cGMP的课程。这些课程获得了巨大成功，受到了多家中国制药公司和监管机构的关注，也受到多个周边国家的产业界和监管机构的关注。第二年，在FDA及多家制药企业的鼎力相助下，北京大学创办了IPEM硕士学位项目。该计划于2007年正式启动，涵盖监管科学、制药科学、制药工程等多个课程模块。

我此次访问中的亮点之一，是为200余位北京大学的学生做了演讲，他们是能够助力加速中国制药行业现代化进程的未来领导者。我谈到了中美之间不断加强的监管合作，以及发展监管科学对确保医药产品研发、审评、批准及生产和安全监测的过程中恪守最高标准的重要性。所有这些都可以使中国、美国、乃至更多患者的生活发生巨变。

同样是在本周，我与中国监管机构的高层官员会面，参观了中国食药总局用于检验假药及污染食品的移动实验室，并出席了在北京召开的第九届全球药监机构首脑峰会。

整个这周，我们讨论了非常棘手的要求全球携手共治的问题。我们的讨论从如何最好地推动生物医药产品的创新，通过仿制药和生物类似药监管路径扩大重要药品的可及性，到使用最新的先进技术和分析方法协调行动，将会怎样更为有效地保护公众免受劣质或假冒产品的伤害。我们还在加强FDA与中国对应机构合作上取得了实质性进展，以更好地监督日趋复杂的国际供应链，努力行动防患于未然。

在准备回程之际，我为此次中国之行所取得的成果深受鼓舞。所有这一切都积极预示着我们在未来推进和保护公众健康的能力方面，前景喜人。

注：一个进口线代表作为一个单独项目列入入境文件货物的部分，参见《FDA特别报告：全球产品与质量安全路径》（2011）。

编译：识林-Kapok 2014-11-22

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China Journal: strengthening relationships to protect public health
Posted on November 21, 2014 by FDA Voice
By: Margaret A. Hamburg, M.D.

I am just about to wrap up a jam-packed five-day visit to China, a fascinating country with a dramatically growing economy and with an increasingly significant impact on the products that Americans consume. Indeed, a key reason for my trip is the important and growing collaboration between FDA and our counterpart agencies in China to ensure the safety of the large volume of foods and medical products exchanged between our two nations.

Margaret Hamburg, M.D.Of the 200 countries that export their products to the United States, China ranks first in exports (in dollar value) to our nation. It is the sixth largest provider of food and the sixth largest provider of drugs and biologics. Only the United States has more FDA-registered drug establishments than China. And these numbers are growing. Between 2007 and 2013, China’s annual exports of FDA-regulated products to the U.S. nearly quadrupled, reaching 5.2 million “lines” (portions of a shipment) of imported goods in 2013.

Ensuring the safety and quality of these and other U.S.-destined FDA-regulated goods is a major challenge. To meet it, FDA has transformed itself— from a domestic agency that focused primarily on products manufactured in the U.S. to a truly global agency grappling with the many challenges of globalization.

Among the many efforts in this area, an important component is the FDA’s establishment of permanent outposts staffed by FDA experts in all major exporting regions, including in China. We have 13 FDA staff members currently stationed in the country, primarily in Beijing. Their job is to help ensure that the food and medical products being exported from China meet our standards. FDA’s China Office does this by providing significant support for the Agency’s inspections in China, by strengthening our relationships with Chinese regulators, by working with industry and other stakeholders, by providing important information and technical assistance to all interested parties, and by analyzing trends and events that might affect the safety of FDA-regulated products exported from China to the United States.

Given the volume of U.S. trade with China, we are working to more than triple the number of American staff we place in China. Placing more FDA experts in China will allow FDA to increase significantly the number of inspections it performs in this dynamic, strategic country, as well as to be more effective partners with our colleagues here in China. Such dramatic staffing increases will also allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry and others.

This week, we took an important step forward in strengthening our relationship with China when we signed an Implementing Arrangement with the China Food and Drug Administration (CFDA). We expect to sign a similar Implementing Arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in the coming weeks. These documents, which build on 2007 agreements with the same two agencies, help to frame the work our inspectors will do in China and create mechanisms for collaboration on inspections.

FDA is also engaging with other stakeholders to create sustainable models for training future champions of regulatory science and quality. Here in China, we helped to create a world-class graduate degree program in international pharmaceutical engineering management (IPEM) at Peking University (PKU), an institution renowned for educating Chinese leaders and thinkers.

This partnership with PKU began in 2005 with just two courses on current good manufacturing practices. These proved hugely successful, and drew attention from Chinese drug companies and regulatory agencies, as well as industry and regulators in neighboring countries. The following year, PKU established a master’s degree program in IPEM, with support from FDA and multinational pharmaceutical companies. The program was formally launched in March 2007, with courses in regulatory science, pharmaceutical science, engineering, and more.

One of the highlights of my trip this week was speaking to more than 200 PKU students, future leaders who will help to accelerate the modernization of this nation’s pharmaceutical industry. I discussed not only FDA’s growing regulatory cooperation with China but the importance of strengthening regulatory science in China to ensure that the highest standards are used to support the development, review, and approval of new medical products, as well as the manufacturing and safety monitoring of medical products. All of this can make an enormous difference in the lives of patients in China, the U.S. and beyond.

Also this week, I met with top Chinese regulatory officials, toured CFDA’s mobile laboratories that test for counterfeit drugs and contaminants in food, and attended the 9th International Summit of Heads of Medicines Regulatory Authorities in Beijing.

Throughout the week, we addressed tough problems that require global solutions. Our discussions ranged from how best to advance biomedical product innovation, expand access to important pharmaceuticals through generic and biosimilar regulatory pathways, and how coordinated action, along with using new, state-of-the art technologies and analytical methods, will more effectively protect the public from substandard or counterfeit products. We are also making tangible progress in strengthening FDA’s partnership with our Chinese counterparts to better oversee the increasingly complex international supply chain and to prevent problems before they occur.

As I prepare for the journey home, I am encouraged by what we accomplished. And all of this bodes well for our ability to promote and protect protect public health in the future.

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