Application list for self inspection and registration of 7 clinical trial data

The official website of the State Drug Administration announced that it had decided to verify the clinical trial data of seven newly received drug registration applications that had completed the clinical trial declaration and production. According to the announcement, before the inspection organized by the State Drug Administration, if the drug registration applicant finds the authenticity of the drug clinical trial data through self inspection, he / she shall withdraw the registration application actively, and the State Drug Administration shall publish the list of drug registration applicants, and shall not investigate their responsibilities.The food and drug audit and inspection center of the State Drug Administration will publicize the on-site inspection plan on its website, and notify the drug registration applicant and its local provincial drug regulatory department. After 10 working days of publicity, the center will notify the on-site inspection date and no longer accept the withdrawal application of the drug registration applicant. For the applicant, the person in charge and manager of drug clinical trial, and the person in charge of contract research organization who found data fraud in the on-site verification of drug clinical trial data, SDA will deal with it seriously according to law. Application list for self inspection and registration of clinical trial data of 7 drugs