On April 19th, Guangxi Food and Drug Administration held a video conference on the supervision business of “two products and one device” in the whole region in 2022 to fully implement the 2022 national drug supervision work conference and the market in the whole region. The spirit of the supervision work conference and the business work conferences of the State Food and Drug Administration will summarize the supervision work of “two products and one device” in the whole region in 2021, analyze the situation in depth, and study and deploy the supervision work of “two products and one device” in 2022. Members of the party group of the bureau and deputy directors Wei Guanghui, Wan Qiu and Shen Hongrui attended the meeting and delivered speeches.
site
div>
The meeting reviewed the main achievements of the “two products and one device” supervision in 2021, and pointed out that the drug supervision departments at all levels in the region resolutely implement the central and autonomous regions, the State Food and Drug Administration and the autonomous region market The decision-making and deployment of the party group of the Supervision Bureau strictly follow the “four strictest” requirements, have the courage to take responsibility, dare to act, seek truth and be pragmatic, forge ahead, promote epidemic prevention and control, strengthen supervision, optimize services, etc., and have achieved solid results. The good results of the company have firmly maintained the bottom line of drug safety, effectively promoted the high-quality development of the pharmaceutical industry, and achieved a good start in the “14th Five-Year Plan”.
The meeting emphasized that in 2022, the supervision of “two products and one device” in the whole region should follow the “1145611” work idea of Guangxi market supervision and the “1+2+8+4” goals and tasks of the Autonomous Region Food and Drug Administration. Adhere to the stability of the word, seek progress while maintaining stability, adhere to the bottom line to ensure safety, pursue the high line to promote development, serve the overall situation of epidemic prevention and control, strictly prevent and control safety risks, support the high-quality development of the pharmaceutical industry, and stabilize the pharmaceutical industry Serve to ensure the overall stability of the region, make greater contributions to building a new era of socialism with Chinese characteristics and a magnificent Guangxi, and welcome the victory of the 20th National Congress of the Communist Party with excellent results.
Wei Guanghui made arrangements for the approval and registration of medical devices, drug production, drug inspection, review and inspection in his speech. First, we must serve the overall situation of epidemic prevention and control, and ensure the quality and supply of epidemic prevention drugs. The second is to continue to deepen the reform of drug device review and approval to boost the high-quality development of the industry. Focus on promoting list management, inter-provincial general handling, micro-reform, and simple handling, implement the priority review and approval mechanism for Class II medical devices, and carry out the action of “strengthening service, solving problems, and promoting development” to serve the development of industrial agglomeration areas. Support the inheritance, innovation and development of traditional Chinese medicine Zhuangyao medicine. The third is to strengthen the quality supervision of pharmaceuticals and equipment, and resolutely stick to the bottom line. Strengthen risk prevention and control, improve the efficiency of random inspection and adverse reaction monitoring, and strengthen safe production. The fourth is to consolidate the technical support foundation and improve the supervision capacity of medical devices.
Wan Qiu made arrangements for policies and regulations, drug circulation supervision, cosmetics supervision, inspection and law enforcement, adverse drug reaction monitoring and training consultation in his speech. First, it is necessary to speed up the improvement of the drug supervision mechanism and build a legal system for drug supervision. The second is to strengthen the risk prevention and control of drug circulation links, and make every effort to ensure the quality and safety of drugs. Focus on in-depth rectification of circulation links, implementation of vaccine quality and safety assurance actions, implementation of epidemic prevention and control in pharmacies and sentinel monitoring, and strengthening the supervision of key varieties and enterprises. The third is to implement the new regulations and supporting regulations, and strengthen the supervision of cosmetics during and after the event. The fourth is to increase the intensity of investigation and handling of cases, and severely punish violations of laws and regulations.
Shen Hongrui made arrangements for the supervision of medical devices in his speech. First, we must earnestly do a good job of special rectification. Focus on the special inspection of illegal sales of medical devices in Guangxi in 2022, the special inspection of medical devices for epidemic prevention and control, the special inspection of sterile and implantable medical devices, the special inspection of condom quality and safety, the special inspection of selected varieties of medical devices Special inspection on the production of dentures in the district and special inspection on illegal operation of decorative color flat contact lenses. The second is to continue to strengthen the supervision of medical devices for epidemic prevention. The third is to carry out a comprehensive investigation of potential risks. The fourth is to conscientiously implement full life cycle management. The fifth is to increase the investigation and punishment of illegal cases and promote the formation of social co-governance.
The meeting was held by video. The Guangxi Food and Drug Administration set up the main venue and each city market supervision bureau set up branch venues. The main responsible comrades of the relevant departments and directly affiliated units of the Guangxi Drug Administration, and all the cadres and workers of the “two products and one machine” business department attended the meeting at the main venue. The leaders of the “two products and one machine” supervision business of the market supervision bureaus of all cities, counties (cities, districts), all the cadres and workers of the relevant departments (stocks), the heads of the inspection institutions responsible for the sampling inspection of drugs in each city, and the Guangxi Drug Administration All cadres and workers of each inspection branch, the administrative examination and approval bureaus of Nanning, Liuzhou, Guilin, Wuzhou, Qinzhou, Beihai and Fangchenggang, and the Nanning, Qinzhou Port, and Chongzuo area management committees of Guangxi Pilot Free Trade Zone are responsible for the licensing work of “two products and one machine” The responsible comrades attended the meeting at the city and county-level branch venues.