China Food and Drug Administration (CFDA) released the Announcement of Self-Examination and Inspection of Drug Clinical Trial Data (No.117, 2015) and the Announcement Application Situation for Registration of Self-Examination and Inspection of Drug Clinical Trial Data (No.81, No.142, No.171, No.202 of 2016 and No.42, No.59 of 2017) , to require drug registration applicants to make the self-examination and inspection of drug clinical trial data for pending applications for drug registration which have been declared to produce or import. After the self-examination of drug registration applicants, there are 106 enterprises taking the initiative to withdraw 135 applications for drug registration (please see the appendix for the list).

It is hereby announced.

Appendix: 1. List of the withdrawal of drug registration application (No.177, 2015).xls

2 . List of the withdrawal of drug registration application (No.81, 2016).xls

3. List of the withdrawal of drug registration application (No.142, 2016).xls

4. List of the withdrawal of drug registration application (No.171, 2016).xls

5. List of the withdrawal of drug registration application (No.202, 2016).xls

6. List of the withdrawal of drug registration application (No.42, 2017).xls

CFDA

June 29, 2017