Shaanxi defines the standards for major cases of pharmaceutical and medical devices

Recently, the food and Drug Administration of Shaanxi Province issued the report on major cases of medical devices and the supervision and supervision system (hereinafter referred to as the system), further standardizing the report on major cases of medical devices and the supervision and supervision work According to the system, cases approved by the State Food and Drug Administration and other ministries and commissions, provincial Party committees, provincial governments and leaders, cases of sudden drug harm, news media and networks with great concern and influence, cases involving more than 200000 yuan, cases of producing and selling fake drugs, cases of narcotics and psychotropic drugs, and cases of abuse of ephedrine containing price base compound preparations are clearly identified And other cases are defined as major cases The food and drug regulatory authorities at all levels are required to report major cases level by level within 2 working days after the case is filed In the report, the source of the case, the basic information of the units or personnel involved in the case, the basic facts of the case or the main illegal facts shall be specified According to the system, for major cases of pharmaceutical and medical devices, major cases not implemented in time as instructed by leaders, administrative omission or abuse of power, as well as cases of prevarication, perfunctory, delay, etc., the Provincial Bureau and the district and City Bureau shall manage the power limit according to the level, mainly from the case investigation, relevant food and drug regulatory departments and other relevant administrative enforcement The cooperation and coordination between legal departments and judicial organs, the facts, evidence, procedures of cases' violation of laws, and the accuracy of applicable laws and regulations shall be supervised and handled by means of telephone, network, letter, dispatch of personnel, meeting, etc In order to strengthen the reporting of major cases and the implementation of supervision and handling work, the system also clearly stipulates that the Provincial Bureau shall include the reporting of major cases in cities divided into districts and supervision and handling work into the annual administrative law enforcement inspection of the system, and carry out strict assessment, rewards and punishments.