摘要
目的 研究美国食品药品监督管理局(FDA)平衡信息公开与保密的内容与机制,为我国提出建议。方法 从FDA信息公开与保密的发展过程,探索信息公开保密的平衡制度设计及机制。结果 美国有严格的法律法规体系支撑,新药申请有明确的主动公开、依申请公开、不得公开规定, FDA IT系统安全计划、CDER专家网络信息披露、审查确认FDA发表的文章或发言的保密规定,确保FDA在信息公开与保密之间权衡考量。结论 建议我国在上位法中引入信息公开保密条款,建立信息公开程序,采取内部信息保密措施。
Abstract
OBJECTIVE To study the content and mechanism of the US Food and Drug Administration (FDA)in balancing information disclosure and confidentiality, and make recommendations for China. METHODS The design and mechanism of information disclosure and confidentiality balance system has been explored from the development of FDA information disclosure and confidentiality. RESULTS The United States has a strict legal and regulatory system. New drug application has series measures to ensure FDA balance information between disclosure and confidentiality, such as active disclosure, request for information and non-public information, FDA IT system security plan, CDER expert network information disclosure, review and confirming of confidentiality provisions in FDA published articles or public speeches. CONCLUSION It is suggested that China introduce the information disclosure and confidentiality clause in upper law, establish information disclosure procedure, and adopt internal information security measures.
关键词
美国食品药品监督管理局 /
信息公开 /
信息保密 /
政府信息 /
措施
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Key words
FDA /
information disclosure /
information confidentiality /
government information /
measures
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陈嘉音, 杨悦.
美国FDA信息公开与保密的研究[J]. 中国药学杂志, 2019, 54(1): 66-71 https://doi.org/10.11669/cpj.2019.01.013
CHEN Jia-yin, YANG Yue.
Research of Disclosure and Confidentiality of FDA Information in US[J]. Chinese Pharmaceutical Journal, 2019, 54(1): 66-71 https://doi.org/10.11669/cpj.2019.01.013
中图分类号：
R951
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参考文献
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[6] US. 21CFR312.130(c)[S]. (2018).
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[9] CDER Network Of Experts [J/OL]. FDA OFFICE OF THE CENTER DIRECTOR,2015-10-23 [2018-07-10]. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM469814.pdf.
[10] CDER CLEARANCE OF FDA-RELATED ARTICLES, SPEECHES, AND OTHER PUBLICATIONS [J/OL]. OFFICE OF COMMUNICATIONS, 2013-10-22 [2018-07-10]. https://www. fda. gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM078816. pdf.
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脚注
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基金
国家食品药品监督管理总局药化注册司课题基金资助(20170012)
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