RESUMEN
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.
RESUMEN
OBJECTIVE:To provide reference for food & drug regulatory authorities in China to disclose government information.METHODS:In the light of the development and status quo of the disclosure of information in US FDA,the access,content and procedure for the disclosure of information in FDA were discussed.RESULTS & CONCLUSIONS:There are many similarities between US and China in the disclosure of information.In view of the practical situation of governmental information disclosure in food and drug regulatory authorities in China,Chinese government should be able to find out such key issues as the human and financial support is much needed in FDA information disclosure,the disclosure level should be in line with our national condition,a three-dimensional publicity system of government information at different level should be established and emphasis should be laid to the key disclosed information etc based on the research on the development,access,content and procedure of information disclosure in FDA.