FDA Revises Nitrosamine Guidance to Extend Recommended Timeframe for Nitrosamine Risk Assessments to March 31, 2021
FDA修订亚硝胺指南，将亚硝胺风险评估的建议时限延长至2021年3月31日
Today, the U.S. Food and Drug Administration is announcing a revision to its September 3, 2020, guidance for industry, Control of Nitrosamine Impurities in Human Drugs.The revision extends the recommended timeframe for manufacturers to assess therisk of nitrosamines in active pharmaceutical ingredients (APIs) and drug products from 6 to 7 months.
今天，FDA宣布对20200903的行业指南“人药中亚硝胺杂质的控制”进行修订，修订内容为将建议生产商评估其API和制剂中亚硝胺风险的建议时限从6个月延长至7个月。
The guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance describes the three-step process manufacturers should follow to mitigate nitrosamine impurities in their products. The first of these steps is assessing the risk of nitrosamine impurities in APIs, marketed products, and products under approvedand pending applications. If an API or drug product is determined to be atrisk, manufacturers should perform the second step: conducting confirmatory testing for the presence of nitrosamine impurities.
该指南向API和制剂生产商建议了检测和预防药品中亚硝胺杂质超出可接受水平的建议。该指南阐述了生产商应当使用三步走的流程缓解其药品中的亚硝胺杂质。第一步是评估API、已上市药品及正在批准过程和审评过程中的申报药品中的亚硝胺风险。如果认定某个API或制剂有风险，则生产商应执行第二步：进行确认性检测，确定是否存在亚硝胺杂质。
To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the first step, the risk assessment of approved or marketed products, within 6 months of guidance publication. Through today‘s revision, FDA extends the recommended timeframe for completion of risk assessments to March31, 2021. Manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents so they are available if requested.
为确保美国药品供应链的安全，本指南建议生产商在指南发布之后6个月完成对已批准和已上市药品的风险评估，即第一步。今天对指南修订之后，FDA将完成风险评估的建议时限延长至了2021年3月31日。生产商不需要向FDA提交其风险评估文件，但需要保存这些文件备查。
FDA官网原文https://www.fda.gov/media/141720/download
中英文
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