"Clinical implied license related functions" opened on the website of drug Audit Center

According to the announcement on adjusting the review and approval procedures of drug clinical trials (No 50 in 2018, hereinafter referred to as Announcement No 50) issued by the State Drug Administration, the drug review center has added the functions of clinical trial application conclusion inquiry, notice download and supplementary information submission on the website The specific matters are notified as follows: 1 Information inquiry of clinical trial application notice "Clinical trial notice inquiry" is added to "hot column" and "information disclosure" on the website of drug audit center The module can inquire the basic information of varieties of "clinical trial notice" 2、 For the purpose of protecting sensitive information, the applicant needs to use a digital certificate (U-Key) for identity authentication to query the clinical trial application conclusion, and visit the "applicant's window → clinical trial application → notice download" module to query and download the electronic notice For the varieties with the review conclusion of "agree to carry out clinical trials", the notice of clinical trials can be downloaded; for the varieties with the review conclusion of "suspend clinical trials", the notice of clinical trials can be downloaded 3、 For the purpose of protecting sensitive information, the applicant needs to use a digital certificate (U-Key) for identity authentication to query the information of clinical trial application, and visit "window of applicant → clinical trial application → notice of supplement" to query and submit supplementary information Since the spontaneous supplementary information is sent to the corresponding column of the applicant's window, the information system will implement the countdown (Beijing time) At the same time, the system will push the supplementary notice to the mobile phone number and email reserved by the contact person of the applicant's window by SMS and email The applicant shall submit the supplementary information in one time within 5 working days If the supplementary information is not submitted within the time limit, our center will follow the requirements of Announcement No 50 Handle Please read the system prompt information of the notice module carefully Tel: 010-68585566 to 3262, 010-68565566 to 3520, drug evaluation center of State Food and drug administration, December 4, 2018