After the issuing of the Announcement of Self-Examination and Inspection of Drug Clinical Trial Data (CFDA’s Announcement No.117, 2015) on Jul. 22, 2015 and Announcement of Self-Examination and Inspection Situations for the Drug Clinical Trial Data of the Registration Applications (CFDA’s Announcement No.81, 2016), CFDA have accepted 82 registration applications which accomplished the application production or importation of clinical trial, CFDA decided to inspect the drug clinical trial data of these registration applications. It is announced of relevant matters as follows:
1. Before CFDA’s inspection, if any authenticity problems be found by the registration applicants in self-examination, the applicants should actively withdraw the registration applications. CFDA will publish the lists and no responsibility will be inquired or investigated.
2. The Center for Food and Drug Inspection of CFDA will publish the on-site Inspection plan on its web-site, and notice the applicants and their located provincial department of food and drug supervision. After 10 days of disclosure, the Center for Food and Drug Inspection of CFDA will notice the date of on-site inspection, and the withdraw application from the applicants will not be accepted any more.
3. For those whose data are found to be fraud in the on-site inspection, CFDA will heavily punish the applicants, persons in charge and responsible persons of the clinical trial, and persons in charge of the contract research organizations. Meanwhile, the responsibilities of inspectors who failed to perform his duties in the food and drug supervision department at corresponding will be investigated.
It is hereby announced.
CFDA
Aug. 30, 2016
