FDA与EU的GMP检查互认

springwxj

Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union


The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
The amended agreement ‎represents the culmination of nearly three years of U.S. Food and Drug Administration and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.
“The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said Dara Corrigan, FDA’s associate commissioner for global regulatory policy.
  
In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which gave the FDA authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. Since May 2014, the FDA and the EU have been collaborating to evaluate the way they each inspect drug manufacturers and assessing the risk and benefits of mutual recognition of drug inspections. The FDA was invited to observe the EU’s Joint Audit Programme, in which two EU nations audit the inspectorate – the regulatory authority – of another EU country. The FDA first observed the audit of Sweden’s inspectorate by auditors from the United Kingdom and Norway. Since then, the FDA has observed 13 additional audits of drug inspectorates across the EU with more audit observations planned through 2017.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.

二马

然后呢？解读一下

一片红云

这样也好，少点检查

成慧潫

费了好大劲才读完，，，，忧桑！学习英语还要加把劲！

springwxj

二马 发表于 2017-3-3 09:36
然后呢？解读一下

没有然后，我也是一知半解？公司正在进行FDA审核，想看看是不是以后过欧盟的GMP是不是相对就好过了？

静水蓝心

springwxj 发表于 2017-3-3 10:33
没有然后，我也是一知半解？公司正在进行FDA审核，想看看是不是以后过欧盟的GMP是不是相对就好过了？

这只是一种机制而已，不会因为你过了其一，另一个检查时就轻松的，人家的尺度向来是严格的。

springwxj

静水蓝心 发表于 2017-3-3 12:00
这只是一种机制而已，不会因为你过了其一，另一个检查时就轻松的，人家的尺度向来是严格的。

嗯，也就是说，还和原来一样，好好准备？

静水蓝心

springwxj 发表于 2017-3-3 12:59
嗯，也就是说，还和原来一样，好好准备？

必须的

北重楼

这样不错

Sarah8023

经过对商业秘密和检查差异的细节讨论后，美国和欧盟（EU）完成了信函交换修订1998年美国-欧盟互认协议的药品附件，并于3月2日宣布已经达成互认协议。根据这一协议，美国和欧盟监管机构将能够利用对方对药品制造设施的药品生产质量管理规范（GMP）检查。
经修订的协议体现了美国FDA和EU作为互认倡议的一部分近三年来合作的顶点，并且将允许FDA和EU药品检查人员依赖在彼此境内开展的药品检查信息。最终，这将使FDA和EU避免药品检查的重复，降低检查成本，并使监管机构能够将更多资源投入到世界上其它风险更高的地区。经修订的协议在双方签字后生效，检查互认可最早可在今年11月适用。
FDA全球监管政策副局长Dara Corrigan表示，“互认协议是与关键合作伙伴协作性和战略性合作中的重要一步，以帮助确保美国患者获得安全、有效和高质量的药品。”欧盟委员会（EC）表示，“加强与美国监管机构的合作将提高EU在工厂成为公共卫生风险之前发现和解决问题的能力。还将减少药品制造商（包括小型生产商）面临的行政负担和成本。”
仿制药行业组织普享药协会（AAM）对协议表示称赞，“AAM很高兴看到FDA通过与EMA更加无缝地合作来简化检查。这种水平的合作将有助于减少重复检查过程并采取措施加速批准 — 这一进展可以增强患者获得安全、有效和更加实惠的药品。”
背景
2012年，国会通过《美国食品和药品管理局安全和创新法案》，法案规定，如果FDA确认国外监管机构有能力开展满足美国要求的检查，FDA有权签订协议协议承认这些国外监管机构开展的药品检查。自2014年5月，FDA和EU一直在合作评价他们每次检查药品制造商的方式，并评估药品检查互认的风险和获益。FDA受邀观察了EU的联合审计计划，联合审计计划即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EU范围内的另外13次对药品检查机构的审计，并在2017年计划了更多审计观察。
《转自盆友圈》 英文不好的可以看看，建议看原文

cnosema

springwxj 发表于 2017-3-3 12:59
嗯，也就是说，还和原来一样，好好准备？

看这个贴，没有提到EU和美国之外的国家/地区哈，所以，该干啥干啥吧

https://www.ouryao.com/thread-349019-1-1.html

Len123

仅仅是欧盟范围内工厂和FDA认证互认，与中国无关。

first-006

感谢楼主分享

木头1985

感谢分享~！