萧惠来.FDA对药品供应链中的企业建立非法处方药核查系统的要求[J].药物评价研究,2019,42(5):809-814
FDA对药品供应链中的企业建立非法处方药核查系统的要求
Requirements of FDA for enterprises in drug supply chain to establish illegitimate prescription drug verification system
投稿时间:2019-02-03  
DOI:10.7501/j.issn.1674-6376.2019.05.001
中文关键词:  美国食品药品管理局;药品供应链;非法处方药;核查系统;指导原则
英文关键词:FDA;drug supply chain;illegitimate prescription drug;verification system;guidance
基金项目:
作者单位
萧惠来 国家药品监督管理局 药品审评中心, 北京 100022 
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中文摘要:
      美国食品药品管理局(FDA)于2018年10月发布了《供企业用的药品供应链安全法规定的某些处方药核查系统指导原则》(草案)。该指导原则介绍了FDA对药品供应链中的企业建立非法处方药核查系统(包括可疑产品的隔离和调查以及非法产品的隔离、处置和通知等)的具体要求。我国目前尚无类似指导原则,详细介绍该指导原则的主要内容,以期对我国药品供应链中的企业发现和清除非法药品有参考价值,对药政部门的管理有益。
英文摘要:
      FDA issued Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (draft)in October, 2018.The guidance introduces the specific requirements of FDA for enterprises in the drug supply chain to establish illegitimate prescription drug verification system, including quarantine and investigation of suspect products as well as quarantine, disposition, and notification of illegal products, etc. There is no similar guidance at present in our country. The guidance of FDA is introduced in detail, which is of great reference value to the enterprises in the drug supply chain of our country to discover and eliminate the illegitimate drugs, and it is beneficial to the management of the drug administration department in this respect.
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