Shaanxi Normal Inspection and Supervision Supervision

The Shaanxi Provincial Food and Drug Administration has issued the “Report on the Major Cases of Drugs and Medical Devices and the Supervision and Supervision System for Drugs and Medical Devices” (referred to as the “System”) to further standardize the reporting of major cases of drug and medical devices and supervision and supervision.

The “System” clearly identifies cases that have been seriously concerned with and have significant impact on cases involving sudden drug injury incidents, news media and networks by the State Food and Drug Administration and other ministries, provincial committees, and provincial governments. Cases of more than 10,000 yuan, cases of production and sale of counterfeit medicines, cases of anesthetic psychoactive drugs, and abuse of ephedrine-containing compound preparations were classified as major cases. Requests food and drug regulatory authorities at all levels to submit reports on major cases within two working days. The report should state the source of the case, the basic information of the unit or person involved in the case, and the basic case or major illegal facts.

The "Regulations" stipulates that cases involving major cases of drug-related medical devices, major cases of leaders' instructions, failure to implement them in a timely manner, administrative inaction, abuse of power, and handling of cases in cases such as pushing, perfunctory, delays, etc. The district/city bureaus shall be subject to hierarchical management rights, mainly from the investigation of cases, relevant food and drug regulatory authorities, coordination with other relevant administrative law enforcement agencies and judicial organs, and the facts of the cases, evidence, procedures, and accuracy of applicable laws and regulations. , Supervising and supervising by telephone, network, letters, dispatching personnel, meetings, etc.

In order to strengthen the implementation of major case reports and supervision and supervision work, the "System" also clearly stipulates that the provincial bureaus shall include the reports, supervisory inspections, and supervision of major districts and cities in the system's annual administrative law enforcement inspections, and carry out strict assessments, rewards, and punishments.