Recently, the reporter learned at a press conference organized by the Langfang Municipal People's Information Office that in recent years, the city has insisted on putting people's life safety and health first, strengthening strict prevention at the source, strict management of the process, strict risk control, and strict punishment for violations, and continued to strengthen drug safety supervision, improve the level of drug safety and security, and actively build a long-term mechanism. The "Working Rules of the Langfang People's Food and Drug Safety Committee" has been formulated, which clarifies the working rules of the Municipal Food and Drug Safety Committee and the work responsibilities of each member unit to ensure that the responsibility for drug safety supervision is implemented. The "Guiding Opinions on Promoting the Standardization of Drug Regulatory Capacity" and "Key Points of Drug Safety Work in Langfang City in 2023" and other documents have been issued to arrange and deploy the city's drug safety work, guide all localities to improve and improve the food and drug safety deliberation and coordination institutions, and realize the full coverage of cities, counties and townships.
Our city deepens multi-dimensional and multi-level risk consultations, comprehensively uses credit supervision, hierarchical supervision, warning education and other means, regularly communicates and judges, supervises and guides enterprises to conduct comprehensive investigation, assessment and rectification of defects and hidden risks, and ensures that the whole process of drug production and operation is legal and compliant. In-depth implementation of the crackdown on "reflux drugs", the remediation of vaccines and traditional Chinese medicine decoction pieces, the improvement of the quality and safety of medical devices, the quality supervision of centralized procurement of medical devices, the "online net and offline source cleaning" of cosmetics, and the special inspection of cosmetics "No. 1 multi-purpose". Focusing on the work requirements of "investigating and handling cases and improving capabilities", we will focus on outstanding problems and weak links, further strengthen the dynamic supervision of quality and safety throughout the life cycle of "two products and one device", effectively deter illegal acts that endanger drug safety, effectively ensure the stability and improvement of the drug safety situation, and resolutely safeguard the health rights and interests of the people. At the same time, we have strengthened departmental coordination, promoted the convergence of criminal cases, strictly investigated and handled major and important cases, and always maintained a high-pressure posture of striking hard and punishing hard. A total of 11,770 drug, medical device, and cosmetics production and operation entities were inspected in the city, and 542 hidden dangers were found, all of which have been rectified, 773 batches of random inspections were organized, 464 drug cases were investigated, and a fine of 388 was imposed530,000 yuan, and 21 case clues were transferred to the public security department.
In order to further promote the high-quality development of the pharmaceutical retail industry, the city has formulated the "Filing Procedures for the Establishment of Self-service Drug Pick-up Machines in Langfang City" to fully support drug retail enterprises to expand drug sales channels. Actively communicate and coordinate with the departments of approval, medical insurance and other departments to help drug retail enterprises connect with medical institutions and medical insurance platforms, and on the premise of ensuring drug safety and facilitating and benefiting the people, drug retail enterprises are allowed to set up self-service drug pick-up machines for medical insurance drugs that meet GSP specifications outside the approved business address, and the relevant self-service drug pick-up equipment only needs to be filed with the market supervision department before being established and operated, which promotes the extension of the drug retail industry**. At present, China Resources Hebei Pharmaceutical Langfang Pharmacy has been filed with the Municipal Bureau, and 4 self-service medicine collection equipment has been put into the medical institutions of Xianghe and Bazhou for early pilot.
In the product development and registration stage of medical device manufacturers, the Municipal Market Supervision and Administration Bureau sent backbone inspectors to follow up and guide the whole process, and carried out one-to-one policy guidance for enterprises in terms of quality system construction, improvement of technical review, system verification data, selection of product registration sample inspection institutions, etc., and completed the on-site registration system verification of 45 varieties of 18 medical device manufacturers.
The establishment of a cooperation mechanism is the basis for deepening the regional linkage of drug safety supervision and law enforcement in Beijing, Tianjin and Hebei. In 2023, the Food and Drug Safety Office of Jinghai District, Tianjin City, Cangzhou City, Hebei Province, and Langfang City, Hebei Province jointly signed the "Memorandum of Understanding on Deepening Cross-regional Cooperation on Food and Drug Safety in Langfang, Cangzhou, Jinghai", proposing for the first time that the supervision sub-bureaus (institutes) of adjacent regions in the three places will establish a collaborative supervision mechanism for off-site production of food and drug enterprises, jointly form a team of food and drug inspectors, and carry out joint inspections of key food and drug varieties and production and business units; The three places will send inspectors to each other to carry out unannounced inspections and quality system inspections on high-risk, unqualified food and drug enterprises or with other problems, so as to further unify cross-regional food and drug safety supervision standards.
In order to further improve the emergency management awareness and management level of the drug regulatory departments in Beijing, Tianjin and Hebei, and improve the coordinated emergency response mechanism for drug safety emergencies, the first Beijing-Tianjin-Hebei drug safety emergency-level emergency drill was held in our city. The drug safety risks have been effectively controlled, and the regional collaborative supervision mechanism has operated efficiently and smoothly, accumulating practical experience and providing a reference example for the response and disposal of drug safety emergencies.