20160113 ECA新闻：FDA关于药用气体认证的新指南

20160113 ECA新闻：FDA关于药用气体认证的新指南

GMP News
13/01/2016

New FDA Guideline on Certification of Medical Gases

FDA关于药用气体认证的新指南

According to the Food and Drug Administration Safety and Innovation Act (FDASIA), XI, Subtitle B, sections 575 and 576, gases for direct administration to human beings or animals have to be certified as medical gases.

根据FDA安全和创新法案（FDASIA），XI，子标题B，第575和576部分，人用或兽用直接摄入气体必须作为药用气体认证。

Recently, the FDA has published a new Guideline as a draft on that topic which details this certification process. For the FDA, certifiable gases are: nitrogen, oxygen, carbon dioxide, helium, Nitrous oxide and air. An additional requirement has to be met, i.e. complying with the requirements of the respective compendia. Here, the FDA refers to the US Pharmacopoeia (USP), the Hom?opathic Pharmacop?ia of the United States (HPUS) as well as to the National Formulary (NF).

最近，FDA公布了关于此主题的新指南草案，其中详细说明了认证程序。FDA认证的气体为：氮气、氧气、二氧化碳、氦气、一氧化氮和空气。要符合一个额外的要求，即符合相应的药典要求。这里，FDA引用了美国药典USP，美国顺势疗法药典（HPUS）以及国家配方集（NF）。

The certification of a medical gas has to take place before the placing on the market for human/veterinary use otherwise the gas is considered as a new non-authorised medical product.

药用气体的认证必须在人用/兽用气体上市前进行认证，否则该气体会被作为新的未经许可的药品。

Normally, the producer of the medical gas submits the application for certification.  An application form for certification is included in the Guideline. Information like type of gas, place of manufacture, a short description of the manufacturing process as well as further measures taken to ensure purity and quality, etc. have to be provided. The FDA indicates a 60-day deadline for the certification process.

一般来说，药用气体生产商提交认证申报。在指南中包括了一份申请表。必须提供诸如气体类型、生产地、生产工艺简短描述以及保证纯度和质量的进一步措施等信息。FDA为认证过程给出60天的期限。

You can find the draft of the Guideline on Certification Process for Designated Medical Gases on the FDA website.

你可以在FDA网站找到上述指南草案。

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