On July 22, 2015, the CFDA promulgated the “Notice on Conducting Self-examination and Verification of Drug Clinical Trial Data†(No. 117 of 2015), and conducted clinical trial verification on 1,622 drug acceptance numbers. After nearly a year of verification, it has undergone verification, resignation, and disapproval. So far, the approval and return rate of 1622 drug acceptance numbers is close to 80%.
It can be said that CFDA chose clinical trials as a punishment for severely punishing R&D data, and chose a more accurate breakthrough. On June 8, 2016, the CFDA issued the “Notice of the General Administration on Conducting Medical Device Clinical Trial Supervision and Spot Checking†(No. 98 of 2016), and put forward new requirements for the quality of medical device clinical trials.
the first. When the clinical trial of the drug begins, the choice is clear. The scope of clinical trial verification is currently a spot check. The notice mentioned that the inspection scope requirement is: in 2016, the medical device clinical trial supervision and inspection adopts a retrospective inspection method, and conducts random inspections on the clinical trial projects carried out by the Food and Drug Administration in the application for registration before June 1, 2016, including all The application for registration of clinical trial data for the third category and imported medical devices in China through clinical trials, taking into account factors such as the degree of risk, the proportion of domestic applications, the applicant's situation, the scale of clinical trial institutions and the number of projects undertaken. , according to a certain percentage. The Food and Drug Administration will issue a notice on the clinical trial project for spot checks.
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