Baoji City Food and Drug Administration of Shaanxi Province Safeguards Drug Safety

In recent years, the Baoji City Food and Drug Administration of Shaanxi Province took the opportunity to severely crack down on illegal food additive and abuse of food additives, and set up a drug safety demonstration counties (districts) as the starting point to pay close attention to the “five major systems” for drug safety construction. Effectively safeguard the people's diet and drug safety. The first is to improve the drug safety responsibility system. We must implement the responsibility of the top leaders of the municipal and county governments and industry departments to personally handle food and drug safety work. Strengthen the responsibility for territorial management, adjust the establishment of drug safety committees at all levels, the main leaders of the government, the Office of Drug Safety Committee on behalf of the government to perform organizational coordination, supervision and inspection responsibilities, the issued documents and the government documents have the same effect. In accordance with the principles of link supervision and supplemented by variety supervision, the duties of various supervisory departments shall be clarified, so that inspections of drug-managing companies will not be indispensable.

The second is to establish a drug safety inspection and monitoring system. On the basis of comprehensive census, and in accordance with the principle of “integration of resources, complementary advantages, centralized management, and unified reimbursement”, the city will formulate plans for the deployment of drug inspection and monitoring facilities throughout the city. The municipal government will allocate funds to avoid duplicated construction and to put them in place; city drug safety The committee office is responsible for the formulation of the city's drug inspection and monitoring management system, unified sampling plan, unified expense reimbursement, and unified information release; increasing the integration of inspection and monitoring resources of departments, establishing the city's food and drug inspection and monitoring center, and gradually realizing the unified centralized management of all drug monitoring agencies. Unified management of personnel and equipment, improvement of technical support capabilities, inspection of monitoring efficiency and rapid emergency response. In response to the shortage of food safety supervision personnel at all levels of the regulatory authorities, especially the agricultural and quality supervision systems, the Municipal Bureau of Municipalities and the Municipal Bureau of Agriculture issued a joint document to draw up personnel for the preparation, adjustment, establishment of agricultural products quality and safety inspection and monitoring stations, and set up inspections in townships and townships. The monitoring room shall be equipped with quality and safety inspectors at the production base to ensure the need for supervision of pharmaceutical companies.

The third is to strengthen the integrity of drug companies. In the city's pharmaceutical industry, the company has launched a wide range of activities focusing on “Sincerity, Quality, and Fresh Breeze” to guide companies in establishing the concept of safe drug development and business integrity. Before the end of this year, a blacklist information database and inquiry system for pharmaceutical production and operation banned practitioners was established in the city. Each regulatory department established a safety credit file for the drug producers and operators according to the system and implemented dynamic hierarchical management. Organize enterprises for different products and processes, on the basis of self-examination and self-correction, update key facilities and equipment, improve process flow, formulate a strict drug safety protection program, and review and record in the supervision department. Drug companies are organized to make public commitments and accept supervision. Establish a withdrawal mechanism for bad companies. Enterprises have quality and safety problems. The main responsible person must publicly apologize to the public. The results of the rectification must be announced in a timely manner. In addition to administrative treatment, the relevant drug dealers must withdraw from the drug. In the field, the main personnel are not allowed to engage in the pharmaceutical industry for life. If criminal responsibility is involved, it shall be handed over to the public security organ and the punishment shall be promptly punished according to law.

Fourth, improve the social supervision system for drugs. The city has selected more than 430 people from the National People's Congress, CPPCC members, and journalists as drug safety supervisors. It has 285 safety coordinators in townships and towns, and 2,234 information workers from village leaders and rural doctors. Establish a horizontal social-supervisory network of medicines that runs horizontally and vertically. Fifth, strengthen the emergency drug management system. According to the principles of “preparation for emergencies, procedures for responding, standards for disposal, measures for aftermath, measures for prevention, and requirements for prevention”, the emergency response mechanism for drug safety classification shall be improved. Strengthen the internal emergency management of enterprises and increase the education and training of employees. In the first half of 2012, a total of more than 13,000 employees of various types were trained. Completely establish product recalls, damages, accountability and accident prevention mechanisms. Adhere to the group defense group control, strengthen daily supervision, timely assessment and early warning, and strive to achieve early detection, early reporting, and early control of drug safety incidents, to minimize the harm caused by the accident, and to protect people's health and life safety.