美国FDA信息公开与保密的研究
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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。
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.
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.
引文
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[4]Citizens Commission on Human Rights v.Food and Drug Administration,1993 WL 1610471 45 F.2d 1325[J/OL].9th Cir.).1995[2018-07-10].https://www.healthaffairs.org/doi/full/10.1377/hlthaff.26.2.483.
[5]Guidance for Industry Advisory Committee Meetings Preparation and Public Availabilityof Information Given to Advisory Committee Members[J/OL].FDA,2008-08[2018-07-10].https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125650.pdf.
[6]US.21CFR312.130(c)[S].(2018).
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[9]CDER Network Of Experts[J/OL].FDA OFFICE OF THECENTER DIRECTOR,2015-10-23[2018-07-10].https://www.fda.gov/downloads/AboutFDA/CentersOffices/Officeof MedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM469814.pdf.
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[2]Public Citizen Health Research Group v.Food and Drug Administration,704 F.2d 1280[J/OL].D.C.Cir.Ct.App,1983[2018-07-10].https://www.citizen.org/article/public-citizenhealth-research-group-v-fda-opening-brief.
[3]Public Citizen Health Research Group v.Food and Drug Administration,2000U.S.Dist.LEXIS4108[J/OL].D.D.C,2000[2018-07-10].
[4]Citizens Commission on Human Rights v.Food and Drug Administration,1993 WL 1610471 45 F.2d 1325[J/OL].9th Cir.).1995[2018-07-10].https://www.healthaffairs.org/doi/full/10.1377/hlthaff.26.2.483.
[5]Guidance for Industry Advisory Committee Meetings Preparation and Public Availabilityof Information Given to Advisory Committee Members[J/OL].FDA,2008-08[2018-07-10].https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125650.pdf.
[6]US.21CFR312.130(c)[S].(2018).
[7]YANG L,TIAN L J,LIN L.Research on the data disclosure system of drug clinical trials and its enlightenment[J].Chin Pharm J(中国药学杂志),2017,52(9):990-998.
[8]Monitoring FDA Personnel's Use of Agency Information Technology Systems[J/OL].FDA,2014-02-26[2018-07-10].https://wayback.archive-it.org/7993/20170111165012/http://www.fda.gov/NewsEvents/Testimony/ucm387237.htm.
[9]CDER Network Of Experts[J/OL].FDA OFFICE OF THECENTER DIRECTOR,2015-10-23[2018-07-10].https://www.fda.gov/downloads/AboutFDA/CentersOffices/Officeof MedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM469814.pdf.
[10]CDER CLEARANCE OF FDA-RELATED ARTICLES,SPEECHES,AND OTHER PUBLICATIONS[J/OL].OFFICE OF COMMUNI-CATIONS,2013-10-22[2018-07-10].https://www.fda.gov/downloads/About FDA/Centers Offices/Officeof Medical ProductsandTobacco/CDER/Manualof Policies Procedures/UCM078816.pdf.