通过国际协作确保药品质量：FDA加强与EMA之间的信息合作交流

巴西木

  转自 徐禾丰
As we’ve written and spoken so much about, the FDA has had to transform itself from a domestically-focused regulatory agency into a 21st century global health organization. This transformation has come in the face of economic and technological changes that have revolutionized how we carry out our mission. We live in a world where other countries increasingly produce—at least in part—the food and medical products our consumers and patients use in their daily lives.
FDA已经不得不从一个以国内为重点的监管机构转变成为21世纪的全球卫生健康组织，这是我们在书面和口头上所不断强调的。这种转变是经济和技术变化所带来的，而这些变化已经彻底改变我们完成使命的方式。现在其他国家对消费者和患者日常生活中使用的食品和医疗产品的生产在不断扩大。

Products the FDA regulates now come from more than 150 countries—many with much less sophisticated regulatory systems than our own. In this international market place, 40 percent of ourfinished drugs are imported, and approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the United States are located outside our borders.
目前有来自多于150个国家的药品受FDA的监管，而这些国家的法规制度远远没有我们的监管制度精细。在这个国际市场，我们大约40%的成品药是进口药品，而接近80%的原料药生产商都来自其他国家。

Ensuring the quality of productsin a global environment is a tall order. At every stage in the production of pharmaceutical products, and all along the global supply chain, things can go wrong.  Products can be improperly formulated, manufactured, or packaged. They can be contaminated or counterfeited. And the challenges are multiplied when the supply chain stretches around the world.
在全球化的环境下确保产品质量是一项艰巨的任务。在药品生产的每个阶段，在全球化的供应链中，任何错误都可能发生。产品的生产处方、生产过程或包装可能不合理；产品可能被污染，也可能是伪造品。所以当供应链全球化后，面临的挑战也变得越来越多。

FDA is on the ground, around the world, inspecting facilities, developing relationships and providing advice.
FDA目前通过对厂房的检查、发展与其他国家的关系、为其他国家提供建议而不断努力，应对各种挑战。

But securing the global supply chain requires more than that. It calls for a cooperative and worldwide endeavor. It means working with our regulatory counterparts abroad to build capacity. It means harmonizing our standards for the sake of safer products and greater efficiency. It means engaging with industry and with regional and international organizations.
但是为了确保全球供应链的安全这些努力是远远不够的，只有全球联合一致、共同努力才能实现这个目标。这就意味着我们需要和其他国家的监管机构携手共进。为了确保产品的安全性和有效性，我们需要对我们的标准进行协调，需要制药行业和地区、国际组织进行交流。

The Food andDrug Administration Safety and Innovation Act (FDASIA), which Congress enacted in 2012, included some importantprovisions designed toimprove the safety and integrity of imported drugs sold in the United States. Some of the provisions are focused on FDA’s inspectional activities overseas. For example, FDASIA increases FDA’s ability to partner with foreign regulatory authorities to leverage resources through increased information-sharing and recognition of foreign inspections.
美国食品和药物管理局安全和创新法案（FDASIA）是国会2012年颁布的，其中包括许多重要规定，目的是改善在美国销售的进口产品的安全性和完整性。也有一些规定强调的是FDA对其他国家的检查。例如：FDASIA提高了FDA与外国监管机构合作的能力，通过增加信息共享和对国外视察的认识，充分利用资源。

We now have more than 60 agreements with foreign counterparts to share certain information in inspection reports and other non-public information that can help us make better decisions about the safety of foreign products.
我们目前在某些检查报告中的信息及其他非公共信息的共享上和其他国家已经达成了60多项的协议，这些信息可以帮助我们更好的判断国外进口产品的安全性。

This type of collaboration not only increases our ability to evaluate pharmaceutical facilities, but allows experts to learn from each other. The result: an outcome whose sum total exceeds its individual parts.
这种合作不仅提高了我们对制药设施的评估能力，而且有利于专家之间的相互学习，总的来说就是集体的力量大于个人的力量。

That is exactly why today we announced an initiative to expand on our existing work to ensure that the public has access to quality pharmaceuticals. Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency(EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection.
为了确保公众能够使用高质量的药物，我们今天倡议对我们现有的工作进行扩展。FDA联合欧盟委员会（EC）和欧盟药品管理局（EMA）提出的这次倡议目的是加深与提供相同公众安全和质量保护的国外监管机构之间的彼此信任。
This mutual reliance initiative builds on our existing relationships with the EC, the EMA, and member states ofthe European Union. Under this new initiative, the goal is to increase our exchange, with the EC and the EMA, of information that is critical to making decisions that protect the public health. And together we will be more efficient and effective in targeting our resources for inspecting pharmaceutical operations.
这种彼此信任是以我们同欧盟委员会（EC）、欧盟药品管理局（EMA）和欧盟各国之间的现有关系为基础的。这次新倡议目的是加强我们同欧盟委员会（EC）、欧盟药品管理局（EMA）之间的信息交流，而这些信息对保护公共安全和健康起着至关重要的作用，同时这次倡议会提高我们对制药操作的检查效率。

This is the latest step in our continuing efforts to improve the quality of pharmaceutical products – a stepthat will deploy a dedicated FDA team to work with our European counterparts on a host of issues. The team, which will focus full time on pharmaceutical quality, will include experts from our Center for Biologics Evaluation and Research, our Center for Drug Evaluation and Research, and our Office of Global Regulatory Operations and Policy.
这是我们在完善药品制品时持续努力的最后一步，在这一步需要由指定的FDA团队和我们欧盟的合作伙伴携手解决一些问题。这个时刻关注药品质量的团队包括来自生物制剂评估和研究中心、药品评估和研究中心和全球监管政策办公司的专家。

As a public health regulatory agency with a global presence, we look forward to strengthening our mutual reliance and capitalizing on our shared interests. The initiative we embraced today signals yet another important step forward for pharmaceutical quality here in the U.S.—and around the world.
作为遍布全球的公共卫生监管机构，我们期望加强彼此之间的相互依赖，实现我们的共同利益。今天我们提出的倡议可能是确保美国药品质量，甚至是全球药品质量的又一个重大突破。

HowardSklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operationsand Policy
Howard Sklamberg, J.D.是FDA全球监管政策办公室的副署长。

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