FDA 互信倡议（MRI）

kslam

FDA Voice

2016年12月7日，作者：Dara Corrigan, J.D. (FDA’s Associate Commissioner for Global Regulatory Policy FDA全球监管政策助理局长。)



For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from FDA and trusted partners, such as those in the European Union, would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where the increase in drug manufacturing has greatly increased, like in China and India.

对于专注于药品质量和安全的FDA专业人员来说，来自于我们投入有限检查资源的国家的进口药物迅速增长是我们极为关注的问题。解决这一问题的一个方法就是建立扩大的检查员队伍，其中来自FDA和可信伙伴（例如欧盟中的合作伙伴）的检查员一起工作，依靠对方的检查，避免重复检查，并在制药业大幅增长的区域执行更多检查, 如中国和印度。

To meet this challenge, FDA has responded with the Mutual Reliance Initiative (MRI). The concept is simple. EU country inspectors inspect in their respective countries, FDA inspects the manufacturing facilities in the U.S., and the EU and FDA would rely upon each other. This would avoid duplication, lower costs, and enable the regulators to devote more resources to other parts of the world where there is greater risk. The savings would be considerable – over the last 5 years, about 40 percent of FDA’s drug inspections were performed in the EU.

为了应对这一挑战，FDA已经采取了互信倡议（MRI）。这个概念很简单。欧盟国家检查员在各自国家开展检查，FDA检查美国的生产设施，欧盟和美国会相互依赖。这将避免重复，减低成本，并使监管机构可以将更多资源投入到世界上其它风险更高的地区。这样的节约将是相当可观的，在过去5年中，大约40%的FDA药品检查在欧盟进行。

The Mutual Reliance Initiative
互信倡议

There is a history to U.S.-EU collaboration. In 1998, in an annex to a U.S.-EU trade agreement, the U.S. and the EU agreed to recognize each other’s good manufacturing practice drug inspections. However, the agreement was never fully implemented.

下面是美国-欧盟合作历史。1998年，在美国-欧盟贸易协定的附件中，美国和欧盟同意承认对方的药品生产质量管理规范（GMP）检查。但是协议从未得到充分执行。

Since 1998, FDA has expanded its reach beyond U.S. borders by opening foreign offices in China, Europe, India, and Latin America. We conduct more foreign inspections now and have gathered more than 15 years of experience in collaborating with the EU.

自1998年以来，FDA通过在中国、欧洲、印度和拉丁美洲开设海外办公室，扩展了其在美国边境以外的范围。我们现在执行更多海外检查，并收集了超过15年的与欧盟合作的经验。

Equally important was the 2012 passage of the Food and Drug Administration Safety and Innovation Act. Congress recognized that FDA cannot and should not monitor the world’s drug inventory by itself and authorized FDA to accept the findings of a foreign inspector when its drug inspectorate is capable of conducting inspections that meet U.S. standards.

同样重要的是2012年《美国食品和药品管理局安全和创新法案》的通过。国会意识到FDA不能和也不应该仅凭自身监测全世界药品库存，授权FDA接受外国检查员的检查结果，当其检查员能够进行符合美国标准的检查。

Working With The EU Inspectorates
与欧盟检查机构合作

The MRI was launched in May 2014. As part of MRI, FDA and EU assembled dedicated teams to assess the risk and benefits of entering into a mutual recognition agreement. FDA was invited to observe the EU’s Joint Audit Programme, in which two EU nations audit the inspectorate – the regulatory authority – of another member. FDA first observed the audit of Sweden’s inspectorate by auditors from the United Kingdom and Norway. Since then, FDA has observed an additional 12 audits of drug inspectorates across the EU with more audit observations planned through 2017.

MRI于2014年5月推出。作为MRI的一部分，FDA和EU组织了专门小组来评估签署互信协议的风险和收益。FDA被邀请观察欧盟的联合审计计划，其中两个欧盟国家审计另一成员国的检查机构 — 监管机构。FDA首先观察了来自英国和挪威的审计员对瑞典检查机构的审计。在那之后，FDA已经观察了整个欧盟范围内的另外12次对药品检查机构的审计，并在2017年计划了更多审计观察。

This unprecedented access allows FDA observers to gather firsthand knowledge of the laws that govern EU GMP drug inspections and how inspectorates manage the drug inventory within their respective borders. Also, interacting with auditors across the EU provides a unique opportunity to understand the regulatory framework in the EU. With 28 member states (27 after Britain leaves the EU), there can be differences FDA must understand.

这一前所未有的途径使得FDA观察员能够收集到关于管治欧盟GMP药品检查的法律的第一手资料，以及检查机构如何在其各自边境内管理药品库存。此外，与整个欧盟的审计员的交流提供了一个独特的机会理解欧盟监管框架。欧盟有28个成员国（在英国退欧之后有27个成员国），FDA必须理解各成员国之间的差异。

And to clarify, the so-called “Brexit” has no impact on FDA’s relationship with our United Kingdom counterparts at this time. Once the UK finalizes its departure from the EU, FDA and the UK will reexamine existing commitments and, if necessary, renegotiate any existing agreements. According to reports, it is likely going to take the UK and EU two years to finalize the terms of the Brexit.

另外需要澄清一点，所谓的“英国退欧”对目前FDA与英国同行的关系没有影响。一旦英国完成退欧，FDA和英国将重新审查现有承诺，如必要，将对任何现有协议重新谈判。据报道，英国和欧盟可能需要两年才能敲定英国退欧条款。

MRI is one of the key components of the pharmaceutical sector covered in the Transatlantic Trade and Investment Partnerships (T-TIP) but could also take another path if the initiative progresses more quickly than the trade negotiations.

MRI是跨大西洋贸易与投资伙伴关系（T-TIP）中涉及制药行业的关键组成部分之一，但如果倡议的进展比贸易谈判更快，也可以采取另一条途径。

The observation and analysis of the drug inspectorates in the EU has only been possible because of the extraordinary devotion and collaboration across FDA. Observers of the audits have included subject matter experts, management, and investigators from the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Office of Regulatory Affairs and the Office of Global Regulatory Operations and Policy. These same FDA employees, and others, guided FDA successfully through the EU’s audit of FDA in September 2015 when the EU visited three district offices, the main campus, and a drug laboratory as part of its assessment. The EU team applied the same criteria that it applies within the EU when it audits its own member states.

由于整个FDA的非凡投入和协作，对欧盟药品检查机构的观察和分析成为可能。审计观察员包括生物制品审评和研究中心、药品审评和研究中心、监管事务办公室和全球监管运营和政策办公室的专家、管理人员和检查员。这些FDA工作人员和其他人员一起引导FDA成功地通过了2015年9月欧盟对FDA的审计，当时作为评估的一部分欧盟访问了三个地区办公室、主管区和一个药物实验室。欧盟团队采用了其在欧盟范围内审计自己的成员国时所用的相同的标准。

Looking Forward
展望未来

What is next? We hope to sign an agreement with the EU soon and are working to complete assessments of the capability of the drug manufacturing inspectorates of two to four countries within the EU.

下一步是什么？我们希望很快与欧盟签署协议，并正在努力完成对欧盟中两个到四个国家的制药检查机构的能力评估。

These first steps with the EU will lead toward our goal of an expanded inspectorate, containing investigators and inspectors from FDA and from across the EU. These collaborations will enhance our ability to evaluate risk, produce better data, and minimize public health risk globally. Indeed, the need to engage globally in different ways is imperative. With MRI, we are moving boldly forward in that direction.

与欧盟的这些第一步将引领我们的扩大检查团队包含来自FDA和整个欧盟的调查员和检查员。这些合作将提高我们评估风险、产生更好的数据，并最大限度地减少全球公共卫生风险的能力。事实上，以不同方式参与全球性工作的需求是迫切的。有了MRI，我们正在朝着这个方向大胆前进。

胜利者

先小人后君子

cts9166

Looking forward, fda

左司马

唉，针对更多的来自中国和印度地区的检查，与欧盟互信——尼玛……

大草原制药人

恐怕只有EU的生产商才首先可以用其中任何EU或FDA检查代替全部检查；而FDA外的就不会这样在了吧？

静水蓝心

都是浮云

cnosema

大草原制药人 发表于 2016-12-19 13:20
恐怕只有EU的生产商才首先可以用其中任何EU或FDA检查代替全部检查；而FDA外的就不会这样在了吧？

为了应对这一挑战，FDA已经采取了互信倡议（MRI）。这个概念很简单。欧盟国家检查员在各自国家开展检查，FDA检查美国的生产设施，欧盟和美国会相互依赖。

涉及的就只是欧盟和美国哈