Changting County Market Supervision and Administration Bureau: multi-dimensional supervision, all-round consolidation, three-dimensional protection of drug and device safety

Recently, according to the spirit of the "Four Clearances" special action plan document issued by the Fujian Drug Administration, the Changting County Market Supervision and Administration Bureau has strengthened the safety supervision of drugs and devices in multiple dimensions in accordance with the spirit of the "Four Clearances" special action plan document issued by the Fujian Drug Administration, combined with the consolidation and improvement of "Clear Prescriptions", "Clear Regulations" and "Drug Safety Villages", and comprehensively consolidated and three-dimensional to ensure the safety of drugs and devices.

Strengthen law enforcement to ensure the quality and safety of public medical devices. Combined with the supervision of drugs and devices, we will carry out special inspections of drug retail enterprises to further standardize the quality of drug and device operations. In this special supervision and inspection, law enforcement personnel will inspect the management of prescription drug sales in accordance with the Measures for the Supervision and Administration of the Quality of Drug Operation and Use implemented from January 1, 2024, focusing on drug retail enterprises in the jurisdiction, to check whether the enterprises do not sell prescription drugs with prescriptions in accordance with the regulations, whether the prescription drugs are sold on the shelves, whether prescription drugs or Class A non-prescription drugs are given to the public in the form of tie-in sales, buy gifts, etc., and whether the licensed pharmacists are not listed for notification when they are not on duty.

There is a "temperature" in law enforcement assistance, and the relationship between law enforcement and assistance is constructed. Highly co-ordinated, high-point planning, efficient organization, in the county-wide to carry out the "I face to face with the enterprise" activities, to further explore the situation, ask the demand, for the enterprise to solve problems, promote standardization, in strict adherence to the quality management standards of drugs, medical devices at the same time, and constantly improve the speed and quality of law enforcement and assistance.

There is "depth" in risk monitoring, and the risk threshold is controlled in advance. Strengthen the quality management of drugs, medical devices, and cosmetics in medical cosmetology institutions, focusing on botulinum toxin type A for injection, urge medical cosmetology institutions to implement traceability responsibilities, establish and implement a traceability system for key drug varieties in accordance with regulations, complete the maintenance of basic information and collect and upload traceability data in a timely manner, and promptly update the use of botulinum toxin type A for injection, so as to ensure that the traceability code is associated with the user. At the same time, products such as sodium hyaluronate, sterile and implantable medical devices are randomly checked, purchase bills and supplier qualifications are checked, transportation and acceptance records are checked, and it is required to strengthen the study of laws and regulations such as the "Measures for the Quality Supervision and Administration of the Use of Medical Devices", improve the quality management level, and ensure the quality and safety of pharmaceutical and mechanized products. Immediate rectification is required for the quality management personnel of individual medical cosmetology institutions to perform their duties in place, and the quality management system is not sound. Strengthen the awareness of the main responsibility of quality and safety, and maintain the good development of the medical aesthetic market.

There is a "breadth" in the implementation of law popularization, so that strict standards are rooted in the heart. Focusing on key areas and object classification policies, focusing on key areas and key issues in the operation of online sales of drugs and devices, facing problems and grasping rectification, strictly investigating violations and promoting norms, and comprehensively preventing and resolving risks and hidden dangers; Enterprises are required to strictly implement the main responsibility, and employees are familiar with relevant laws and regulations, and standardize daily business behavior.

Up to now, a total of 52 pharmaceutical business enterprises, 64 medical device business enterprises, 8 medical beauty institutions, 297 inspectors have been dispatched, and 83 enterprises have been helped to standardize their operations. In accordance with the management laws and regulations on the quality of drugs and medical devices, 3 companies were ordered to rectify and 5 were investigated and punished.

Source: Changting County Market Supervision and Administration Bureau