The regulations for the confidential management of drug review and approval information have been issued

Recently, the State Drug Administration announced the Implementation Rules on Strengthening the Confidentiality Management of Drug Review and Approval Information (hereinafter referred to as the Regulations) to safeguard the legitimate rights and interests of drug registration applicants, standardize and strengthen the confidential management of drug review and approval information, and ensure the lawful and efficient operation of drug review and approval.
The Regulations specify that the following four types of information fall within the scope of confidentiality: information submitted by applicants during the review and approval phase, production processes, key technical parameters, know-how, test data, etc. that are trade secrets, technical secrets, and personal privacy information; The information disclosed for review and approval includes all kinds of meeting information, expert information, the conclusions of the review and approval that have not yet been issued, as well as the discussion opinions, advice and technical reports in the process of the unanncied review and approval;
The Regulations treat 13 situations as the disclosure of confidential information: unauthorized disclosure of the applicant's technical information or other trade secrets; unauthorized use or allowing others to use trade secrets, technical secret information or personal privacy information belonging to the applicant for non-work purposes; the conclusions of the review and approval, the unauthorized disclosure of the discussion opinions, advice and technical reports in the process of the unremissed review and approval, the disclosure of the information on the reporting of complaints related to the review and approval work, the unauthorized reproduction, shooting, transcription and recording of relevant paper or electronic confidential information, the unauthorized release of confidential information from the workplace or the unauthorized use of confidential information outside the designated network and equipment, the disclosure of the login password of the drug review information network system to other personnel, and other acts of confidentiality determined by the State Drug Administration. (China Medical Journal)