美国FDA药品审评保密政策及启示

US FDA drug review confidentiality policy and its implications

药品审评机构每天都要处理大量的涉密信息,保密管理是药品审评机构的重要职责。本文通过分析美国FDA保密法律法规、保密信息分类、具体保密政策和措施以及近几年发生的泄密案件,对建立和完善我国药品审评保密制度提出3条建议。

Confidential information control and management is an important duty and responsibility for the drug regulatory authorities, as they deal with a lot of confidential information every day. By analyzing the laws and regulations of US FDA for confidential information, category and detailed policy for confidential information, and case analysis for recent security breaches, this paper proposes three suggestions for the establishment and improvement of Chinese drug review confidential information control and management system.