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Local：Home-> Industry The self-check time-limited filing system is open again, and it will not be reported befor
Time：2020-08-17Click：
Relevant units:
According to the requirements of the Notice of The State Food and Drug Administration on Self-examination and Verification of Application for Registration of Drug Clinical Trial Data (No. 202 of 2016), the verification center will open the self-examination and reporting system of drug clinical trial data to drug registration applicants of the varieties involved in the announcement from now on. Please drug registration applicant from January 9, 2017 - January 20, logon administration of state food and drug supervision and administration of the food and drug audit inspection center web site, www.cfdi.org.cn, in the public service area, select the "fill in" online "online office", click "clinical trial data check list report provided" (or direct access to the web site: http://221.122.47.226:9082/esa/login_scqy.jsp) to fill in. If the report is not submitted after the deadline, the verification center will not arrange on-site verification.
The relevant particulars are explained as follows:
1. Please download and read the Filling Instruction and User Operation Manual carefully before filling.
2. Please download and read the Letter of Commitment carefully, and sign and stamp it.
3. Please fill in the form one by one according to the filling requirements to ensure that the information is true and valid. Please contact 010-87559031 for content questions and 010-87559072 for system technical questions.
4. After completion and confirmation, please print the self-Examination Report Form and sign and seal it.
5. Please send scanned copies of "Materials required for self-examination Report" and "Letter of Commitment" in the self-examination report and submit electronic documents as required.
6. Please mail the information under items 2, 4 and 5 to the Food and Drug Inspection Center of China Food and Drug Administration in the following format:
To: Verification Team, Research and Verification Office
Company name: Food and Drug Examination center
Address: Floor 3, Building 11, Fahua Nanli, Dongcheng District, Beijing
Mail editor: 100061
Telephone: 010-87559009