20160119 ECA新闻：FDA建议：减少通过血液和血液制品传播HIV的风险

20160119 ECA新闻：FDA建议：减少通过血液和血液制品传播HIV的风险  

GMP News
19/01/2016

FDA Recommendations: Reducing the Risk of HIV Transmission by Blood and Blood Products

FDA建议：减少通过血液和血液制品传播HIV的风险

With our News from May 2015, we reported about the draft guideline "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". In December, the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER) published the adopted version of this guideline. The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.

在我们2015年5月的新闻中，我们报道了关于“修订后建议：减少通过血液和血液制品传播HIV的风险”指南草案。在12月，FDA的CBER公布了此指南的最终版本。本指南中包括的建议适用于血液和血液成分，包括血浆：

The document includes amongst introduction and references the following chapters:

除介绍和参考文献外，文件包括以下章节：

"II. BACKGROUND背景
A. History of Efforts to Reduce HIV Transmission by Blood Products 减少通过血液制品传播HIV的努力历史
B. Current Risk of HIV Infection Associated with Specific Behaviors 目前与特殊行为有关的HIV风险
C. Recent Data Relevant to the Deferral for MSM 与MSM延期有关的近期数据
D. Considerations of the BOTS Working Group /BOTS工作组的考量
E. Outcome of Advisory Committee Meetings建议委员会会议的结果
F. Evaluating Alternative Policy Options Using Available Evidence采用收集到的证据评估可替代政策的选择
G. Status of Other Deferral Categories其它延期类型状态

III. RECOMMENDATIONS建议
A. Donor Educational Material and Donor History Questionnaire献血教育材料和献血历史问卷
B. Donor Deferral 献血延期
C. Donor Requalification 献血者重新确认
D. Product Retrieval and Quarantine; Notification of Consignees of Blood and Blood Components药品恢复和暂扣，血液和血液组分货运通知
E. Product Disposition and Labeling药品处理和标签
F. Biological Product Deviation Reporting 生物制品偏差报告
G. Testing Requirements and Considerations"测试要求和考量

As part of this revision the FDA makes recommendations related to the risk groups among the donors, donor deferral and  their expectations for a subsequent updating of the documentation and procedures for:

作为修订的一部分，FDA给出了关于献血者中风险人群、献血延期和其对随后的文件和程序的更新：

• Donor history questionnaire  
• 献血历史问卷
• Donor education materials
• 献血教育材料
• Donor requalification
• 献血重新确认
• Product management procedures such as product retrieval and quarantine
• 产品管理程序，例如产品恢复和暂扣
  

And finally, in chapter IV, the guideline gives further information for the implementation:
"You may implement these recommendations once you have revised your donor educational material, DHQ, including full-length and abbreviated DHQs, and accompanying materials to reflect the new donor deferral recommendations. Licensed blood establishments must report the indicated revisions to FDA in the following manner (21 CFR 601.12):

最后，在第IV章中，指南给出了更多关于实施的信息“你可以在你修订了你的献血教育材料、HDQ，包括全长度和生产力的DHQ，以及一起发放的材料来反映新的献血延期建议后再实施这些建议。持证的血液组织必须以以下方式（21CFR 601.12）向FDA报告指示的修订：

1. Revision of your own donor educational materials, DHQ and accompanying materials must be submitted to FDA as a prior approval supplement (PAS) under 21 CFR 601.12(b).

修订你自己的献血教育材料、DHQ和一起发放的材料必须提交给FDA，作为提前批准补充（PAS），按21CFR 601.12(b).

2. Revision of a previously FDA accepted DHQ and accompanying materials must be reported as a major change if you are revising the FDA accepted DHQ and accompanying materials to implement these new recommendations. Report such a change to FDA as a prior approval supplement (PAS) under 21 CFR 601.12(b).

之前FDA接受的DHQ和一起的材料的修订版本必须报告作为主要变更、如果你正在修订FDA已接受的DHQ及一起的材料来实施这些新的建议。这类变更应报告给FDA作为提前批准补充（PAS），按601.12(B)。

3. If the current version of the donor educational materials, DHQ and accompanying materials prepared by the AABB Donor History Task Force or PPTA are revised to contain the recommendations in this guidance and are found acceptable by FDA, we would consider the implementation of the donor educational materials, DHQ and accompanying materials to be minor changes, if implemented without modification and in their entirety as a complete process for administering questions to donors. Report such a change to FDA in your annual report under "21 CFR 601.12(d), noting the date the process was implemented."

如果现行献血教育材料版本、DHQ和一起的材料是由AABB献血历史任务组织或PPTA，修订后包括本指南中的建议，并且FDA认为可以接受，我们要考虑献血教育材料、DHQ和一起的材料的实施作为轻微变更。如果不需要进行修订即可实施，并且其整个作为一个完整的流程来管理给献血者的问题。在年报里将该变更报告给FDA，通知其实施日期。

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