and Inspection of Drug Clinical Trial Data (No. 171, 2016)
After the issuing of the Announcement of Carrying out the Self-examination and Inspection of Drug Clinical Trial Data (CFDA Announcement No. 117, 2015), Announcement of the Registration Application of Self-examination and Inspection of Drug Clinical Trial Data (CFDA announcement No. 81, 2016) and the Announcement of the Registration Application of Self-examination and Inspection of Drug Clinical Trial Data (CFDA announcement No. 142, 2016), the CFDA has newly received 55 applications from medical institutions for registration of manufactured or imported drugs after having completed the clinical trial, and decides to inspect the drug clinical trial data of these registration applications (see the appendix). The relevant matters are announced as below:
I. Before the CFDA organizes the inspection, if the applicant for drug registration finds that the drug clinical trial data has authenticity problems during self-examination, it shall withdraw the registration application voluntarily. CFDA shall announce their name list without investigating for their responsibilities.
II. Center for Food and Drug Inspection (CFDI) of CFDA shall announce the on-site inspection plan on its website and notify the drug registration applicant of the drug and the provincial food and drug regulatory department where the applicant locates. CFDI shall notify the date of on-site inspection 10 working days after the announcement, and shall not accept the withdrawal application from the drug registration applicant.
III. The CFDA shall give a heavier punishment for the applicant, director and management personnel of the drug clinical trial and person in charge of the contract research organization if the fabrication of drug clinical trial data is found during the on-site inspection, and shall investigate the responsibilities of inspection personnel from the food and drug regulatory department failing to perform their duties effectively.
It is hereby announced.
CFDA
November 1, 2016
