20160120 ECA新闻：FDA新兴技术应用项目---指南草案

20160120 ECA新闻：FDA新兴技术应用项目---指南草案

GMP News
20/01/2016

FDA?s Emerging Technology Applications Program - Draft Guidance

FDA新兴技术应用项目---指南草案

On December 23, 2015, the FDA published a draft guidance for industry "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base". Comments and suggestions regarding this draft document should be submitted within 60 days of publication.

在2015年12月23日，FDA公布了一份行业指南草案题为“新兴技术应用的先进性使得药品生产基础现代化”，关于此指南草案的建议应在公布后60天内提交。

The draft guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC (chemistry, manufacturing, and controls) information containing emerging manufacturing (including testing, packaging and labeling operations, and quality control) technology to FDA.

指南草案中给有兴趣参与提交CMC（研发、生产和检测）创新生产技术（包括测试、包装和标签操作和质量控制）给FDA的制药公司提供了建议。

The program is open for new drug applications (INDs), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA). It only affects the quality section of a submission (CMC and facility-related information).

该项目向新药申报（IND）、新药（NDA）原始申报和增补、仿制药（ANDA）和生物许可申报（BLA）开放。它只是影响申报资料的质量部分（CMC和与场所相关的资料）。

The development of emerging manufacturing technology, like, for example, aseptic manufacturing facilities with highly automated systems and isolators, may lead to improved manufacturing, and therefore improved product quality and availability throughout a product?s lifecycle.

新兴生产技术的研发，例如，高度自动化系统和隔离器的无菌生产设施，可能会引起生产改善，从而提高产品质量，并在产品的整个生命周期均可以获得。

Pharmaceutical companies can submit questions and proposals about the use of these technologies to a group within CDER (Emerging Technology Team - ETT).

制药公司可以提交关于此技术使用的问题和提议给CDER的一个工作组（新兴技术组---ETT）。

The draft guidance is a follow-on to the FDA guidance for industry "PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance" which describes the concept that quality cannot be tested into products. It should be built-in or should be present by design. Through the ETT, FDA intends to encourage the adoption of innovative approaches by leveraging existing resources of FDA to facilitate regulatory reviews of submissions.

指南草案是对FDA行业指南的跟进“PAT—创新药品研发、生产和质量保证框架”，其中描述了质量不是被检测出来的概念。它应该是被设计出来嵌入产品的。通过ETT，FDA想要通过平衡已有资源来方便申报资料的法规审核，来鼓励采用创新方法，

Examples of emerging technology elements include an innovative or novel:

新兴技术要素包括创新例如：

• Product manufacturing technology, such as the dosage form;
• 药品生产技术，例如剂型
• Manufacturing process (e.g., design, scale-up, and/or commercial scale);
• 生产工艺（例如，设计、放大和/或商业规格）
• Testing technology.
• 检测技术
  

Interested parties should submit a written meeting request to participate in the ETT program at least three months prior to the planned application (IND, ANDA, BLA, NDA) submission date. In addition to the items outlined in the FDA guidance "Formal Meetings Between the FDA and Sponsors or Applicants" the request should also include the following items:

感兴趣方应在计划提交申报资料（IND、ANDA、BLA、NDA）前三个月，提交书面的会议申报来参加ETT项目。除了在FDA指南“FDA与申报人或发起人之间正式会议”中列出的项目外，还应包括以下项目，

• A brief description of the proposed testing, process, and/or proposed technology;
• 提议检测、工艺和/或所拟技术的简单描述
• A brief explanation why the proposed testing, process, and/or technology are substantially novel and unique;
• 简单解释为什么所拟的测试、工艺和/或技术具有显著创新和唯一性
• A description of how the proposed testing and/or technology could modernize pharmaceutical manufacturing and thus improve product safety, identity, strength, quality, or purity;
• 描述所拟的测试和/或技术如何创立药品生产现代化，从而增进药品安全性、有效性、剂量、质量或纯度
• A summary of the development plan and any perceived roadblocks to technical or regulatory implementation;
• 研发计划摘要，以及预计会出现的技术或法规实施障碍
• A timeline for submission.
• 申报时间表
  

The request should generally not exceed five pages and FDA expects to notify companies of its decision regarding acceptance into the program within 60 days of receipt of the request. Once accepted into the program, the participant can engage with ETT and CMC in accordance with existing meeting procedures and guidances (e.g. above mentioned FDA guidance on Formal Meetings).

申请一般不超过5页纸，FDA期望在收到申请之后60天内通知公司其是否接受进入此项目的决定。一旦被接受进入项目，则参与者可以根据现有会议程序和指南参与ETT和CMC（例如，上述FDA对正式会议的指南）。

For further information, please find all the details in the draft guidance "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base".

更多信息，参见指南草案。

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