Year-end summary of 2019 and work plan for 2019
Since the beginning of this year, under the leadership of the Municipal Party Committee, the Municipal Government and the Provincial Bureau, the Office has focused on ensuring the safety of the people's diet and medicine in the city, insisting on guiding the work of food and drug supervision with the scientific development concept, updating ideas, improving work style and innovation. The supervision methods and the ability to improve the administration according to law have been carried out actively and in an orderly manner with obvious results.
I. XX year work review and integration of resources, find the right position, food safety work in an orderly manner.
First, continue to fulfill the comprehensive food safety supervision function. Before the adjustment of the comprehensive food safety supervision function, continue to play the leading role of the municipal government food safety. The XX annual food safety target assessment was carried out for the three districts, six districts and 14 member units, and the advanced units were commended. The implementation of the city's food safety and rectification work implementation plan, the deployment of food safety work tasks this year. We will take the lead in launching a four-month special campaign to crack down on illegal additions of non-edible substances and food abuse agents. The special rectification work of the city has been fully affirmed by the joint supervision team of the provincial special rectification leading group. Organize supervision and inspection with relevant departments during the high-incidence period of food safety accidents such as festivals and seasons. 15 cases of food complaints and reports were accepted, all of which were handled in time or transferred to relevant departments for verification. Organized the promotion of the "Food Safety Law" and successfully completed the "Tianchen Cup" food and drug safety knowledge contest.
The second is to carry out food safety work in the catering service sector. After June 1st, the food safety supervision function of the food and beverage chain was transferred to our bureau. We actively performed our new functions and started well. Organize the summer food and beverage chain food, health food safety special rectification and school canteen food safety special supervision and inspection. The Union City Education Bureau will conduct special supervision and inspection of food safety in school cafeterias from the end of August to mid-October on the canteens of the city's colleges and universities, vocational and technical schools, Chinese, national and kindergarten, and other catering units in the school. Actively carry out catering service licensing and supervision work, issue 147 catering service licenses, handle 13 complaints and reports on catering service links, participate in 6 on-site investigations of suspected food poisoning incidents, and organize 5 food safety guarantees for major reception activities. . Formulate the “Emergency Disposal Plan for Food Safety Accidents in the Catering Service Link during the National Day and Mid-Autumn Festival” in XX, and participate in the joint food safety inspection before the holiday. In conjunction with the Health Supervision Bureau of the Municipal Health Bureau, a letter to the city's catering service enterprises was issued. Opened a food and drug safety work briefing platform for food and beverage, and published more than 2,300 food and drug safety newsletters.
Implement responsibility, highlight key points, and comprehensively supervise the whole process of drug and machinery safety.
Highlight source governance. GMP tracking and inspection of pharmaceutical companies such as Global Pharmaceuticals and Tushan Pharmaceuticals will strengthen the supervision of key high-risk enterprises such as urban pharmaceuticals, and timely deal with problems in production and quality management. Organize the re-examination of the qualifications of the anesthetic drugs and psychotropic drugs management enterprises, and carry out special inspections of the compound preparation containing ephedrine.
Strengthen circulation and rectification. We carried out a special inspection on the license renewal of medical equipment, and inspected 41 enterprises that need to change their licenses; re-implemented gsp identification for six pharmaceutical wholesale enterprises and gsp identification for 66 retail pharmacies. Strengthen the monitoring of illegal advertisements. From January to September, a total of 10,102 fake and illegal drug advertisements were monitored, all of which were handed over to the industrial and commercial department for processing. The training practitioners had 458 people in 7 sessions and organized 1052 physical examinations. 3,820 reports of adverse drug reactions were reported. Promote the "two networks" upgrade, this year added 34 medical institutions "standard pharmacies."
Strengthen medical device supervision. Conducted special inspections of high-risk medical device operators, and inspected 54 high-risk medical device operators; inspected 2 custom denture manufacturers, and logged out 5 medical device business licenses, and banned one unlicensed contact lens business . 62 medical device adverse event monitoring networks were established, and 657 medical device adverse events were reported.
Heavy punches and fakes. Up to now, a total of 82 cases of drug-related machinery have been investigated, including 81 drug cases and 1 device case, and 2 unlicensed business households have been banned; 74 varieties of counterfeit drugs and medical devices have been destroyed, with a value of 57,000 yuan; 11 complaints were reported and all were promptly checked and reported to the complainant, and one of them was investigated and investigated. The city has sampled 597 batches and has completed 539 batches of inspections.
Strengthen emergency response. A comprehensive plan for the prevention and control of influenza A (H1N1) was launched in response to the emergency response plan for influenza A (H1N1). Organize pharmaceutical machinery enterprises to implement the production, procurement and storage tasks of emergency medical equipment, carry out special supervision and inspection of production, operation and use units of emergency medical equipment, work on strict duty and leadership system, and respond to the city's response to influenza A (H1N1). The epidemic provides quality and safety and reserve guarantee for the prevention and control of medical devices.
Change concepts, do a good job, and promote the steady development of the pharmaceutical economy.
The full implementation of the “Revitalization of Peony Drug Action Plan” has achieved remarkable results. The China Medical News has specifically interviewed and reported to the city. Adopting the analog identification method, the enterprises that need gmp identification should be involved in advance, and the enterprises with weak management foundation should be stationed in the enterprise to help and guide the enterprise rectification. This year, the identification projects of the identification enterprises in the city in the national and provincial identification inspections are significantly less than last year. Up to now, 12 production lines of 6 enterprises in the city have passed the national and provincial gmp identification and inspection. Actively coordinate with the provincial bureau to help Fufengyuan Tushan Pharmaceutical Co., Ltd. solve practical problems such as registration of soft bag packaging materials and supplementary application for drug packaging changes. To help solve the problem of the reorganization of Fubo Pharmaceutical Chemical Co., Ltd. and Tushan Pharmaceutical Factory, the 8,000-ton paracetamol drug substance project was successfully identified by gmp. Helping 蚌埠泰生物股份有限公司 to obtain a drug production license, the city has added a large-scale pharmaceutical production enterprise. Under the specific guidance of our bureau, Qingda Deren Brain Health Therapy has obtained the product registration certificate and the product has been listed. Regularly hold seminars on drug wholesale business management to help companies adjust their business ideas and continuously expand drug sales channels. Build an independent innovation platform and actively promote the transformation of scientific and technological achievements. The national first-class drug, etoxoxacin hydrochloride, developed by Global Pharmaceuticals and the Shanghai Institute of Materia Medica in the Chinese Academy of Sciences, is China's first quinolone anti-infective drug with completely independent intellectual property rights. It was officially launched into the market in July, which is also the city's autonomy. One of the major achievements of innovation. Organize the industry, academia and research matchmaking meeting, and reach five agreements and intentions such as scientific research transformation, joint research and development, and solving production technical problems. This year, the total drug sales in the city has grown by 20% over the same period last year. The output value of the pharmaceutical industry is 700 million yuan, and the sales income is 680 million yuan, up 20% and 30% respectively over the same period of last year; the profit and tax is 90 million yuan, more than double the same period of last year. In the context of the financial crisis, the city's pharmaceutical economy has maintained rapid and healthy development.
Since the beginning of this year, all the work of the bureau has been carried out in a solid and effective manner. The municipal government has achieved excellent results in the assessment of the objectives of the city. It has successively won the city's advanced units for legal administration and the use of academic law, the advanced units of the party committee's information work, and the construction of the rural "two networks" in the province. Honorary title of work advanced unit. At the same time, the Fujian Food and Drug Inspection Center was actively established. The municipal government held a coordination meeting of relevant departments for four consecutive times to conduct a special study on the construction of the food and drug inspection center. At present, the project site selection and construction funds have been basically determined.
Second, XX year work ideas and arrangements
In XX years, with the guidance of the scientific development concept and the Fourth Plenary Session of the Party's XX Session, the bureau will continuously improve the food and drug supervision capabilities and comprehensively guarantee the safety of people's diet and medication in our city.
Actively perform new duties of supervision.
In combination with the characteristics of catering consumption in the city, the short-term and medium-term goals of catering unit rectification will be formulated. Strict licensing conditions, refine the review criteria, and further standardize the acceptance, review, approval and certification of licenses and instruments. Efforts were made to carry out special rectification activities for unlicensed and unlicensed business households with fixed business places, and to establish small food and beverage demonstration points as a means to play a leading role in demonstration sites. Increase the supervision and disinfection of tableware, increase the intensity of food sampling, implement rapid inspection methods, and expand the coverage of inspections. Cooperate with relevant departments to carry out special inspections of various canteens. Do a good job in catering safety protection for all major events; strengthen laws and regulations training, standardize law enforcement behaviors, standardize the business operations of catering service industry; actively cooperate with relevant departments to do food poisoning investigation work; do a good job in investigating illegal activities of catering service enterprises according to law . Organize the safety supervision of health products and cosmetics, strengthen the daily supervision and guidance of health products, cosmetics production and management enterprises, and do a good job of rating the cosmetics and health food production enterprises in the jurisdiction. Carry out health food, cosmetic safety evaluation and adverse reaction monitoring.
Keeping the pressure of the drug regulatory supervision is not lax.
Strengthen the dynamic supervision of pharmaceutical production enterprises, adopt a combination of follow-up inspection, flight inspection and special inspection to supervise and inspect all pharmaceutical production enterprises in the city, with coverage rate of more than 100%, and focus on the supervision of injection production enterprises. The frequency of inspections reached 3 times. Special inspections were carried out on three pharmaceutical packaging materials manufacturers such as New Huangshan Glass Co., Ltd. Strengthen daily supervision and inspection of products entering the national essential medicines catalogue. Supervise and help companies to do gmp identification and re-identification work. Carry out drug re-registration work. We will further promote the production process and prescription verification work, strengthen the supervision of the production of high-risk drugs, and strengthen the dynamic supervision of the city's hemp drugs.
Strengthen the management of drug purchase and sales channels, and rectify illegal and illegal behaviors such as “joining operations” and “walking tickets” in the circulation of drugs. Standardize the circulation order of Chinese herbal medicines and Chinese herbal medicines. Establish records of bad behaviors of pharmaceutical and medical device companies and make them known to the public. Implement a more rigorous product recall system. In conjunction with the industry and commerce departments to increase the investigation and punishment of illegal drug medical device advertising, focusing on monitoring and combating the use of the Internet to publish false advertising and false publicity. Establish a national essential medicine production supply and quality assurance mechanism. Carry out special inspections on the quality of anti-control H1n1 influenza drugs. Carry out special inspections on the quality of medicines and medical devices in medical institutions, strengthen the monitoring of adverse events of medical devices and emergency management of drug safety, improve the emergency plan for emergency incidents of medical devices, and establish and improve the daily supervision files of medical device manufacturers.
We will maintain the anti-counterfeiting and high-pressure situation, strengthen the operation and management of drug testing vehicles, and do a good job in sampling inspection. Improve the monitoring network for adverse drug reactions and medical device adverse events, and improve the quality of case reports.
Promote the healthy development of the food and pharmaceutical industry.
Actively help pharmaceutical companies solve problems and problems, actively reflect the needs of pharmaceutical companies in development, and coordinate relevant departments to optimize the external development environment of pharmaceutical companies. We will increase the assistance in drug registration and production, and actively support the pharmaceutical production enterprises in our city to enter the national essential drug catalogue into the national designated production. Increase the support of independent innovation enterprises. Through the implementation of measures such as drug gmp management and quality system assessment system, we will comprehensively improve product quality and safety standards and enhance core competitiveness. Promote the integration of academic research institutions and enterprises. Encourage enterprises to establish a number of key laboratories, technology research and development centers, pilot test bases, clinical research bases, etc. with the Pharmacy Department of the Affiliated Hospital of Fujian Medical College, Fengyuan Medical Technology Development Co., etc., to build a platform for technology development and innovation, and accelerate products. R&D and innovation. Actively explore and standardize the catering industry, health food, cosmetics industry, promote the chain operation of the catering industry, and standardize services. We will introduce health food and cosmetics production enterprises, cultivate health-related industries, and strive to promote the development of the food and medicine economy in our city.
I. XX year work review and integration of resources, find the right position, food safety work in an orderly manner.
First, continue to fulfill the comprehensive food safety supervision function. Before the adjustment of the comprehensive food safety supervision function, continue to play the leading role of the municipal government food safety. The XX annual food safety target assessment was carried out for the three districts, six districts and 14 member units, and the advanced units were commended. The implementation of the city's food safety and rectification work implementation plan, the deployment of food safety work tasks this year. We will take the lead in launching a four-month special campaign to crack down on illegal additions of non-edible substances and food abuse agents. The special rectification work of the city has been fully affirmed by the joint supervision team of the provincial special rectification leading group. Organize supervision and inspection with relevant departments during the high-incidence period of food safety accidents such as festivals and seasons. 15 cases of food complaints and reports were accepted, all of which were handled in time or transferred to relevant departments for verification. Organized the promotion of the "Food Safety Law" and successfully completed the "Tianchen Cup" food and drug safety knowledge contest.
The second is to carry out food safety work in the catering service sector. After June 1st, the food safety supervision function of the food and beverage chain was transferred to our bureau. We actively performed our new functions and started well. Organize the summer food and beverage chain food, health food safety special rectification and school canteen food safety special supervision and inspection. The Union City Education Bureau will conduct special supervision and inspection of food safety in school cafeterias from the end of August to mid-October on the canteens of the city's colleges and universities, vocational and technical schools, Chinese, national and kindergarten, and other catering units in the school. Actively carry out catering service licensing and supervision work, issue 147 catering service licenses, handle 13 complaints and reports on catering service links, participate in 6 on-site investigations of suspected food poisoning incidents, and organize 5 food safety guarantees for major reception activities. . Formulate the “Emergency Disposal Plan for Food Safety Accidents in the Catering Service Link during the National Day and Mid-Autumn Festival” in XX, and participate in the joint food safety inspection before the holiday. In conjunction with the Health Supervision Bureau of the Municipal Health Bureau, a letter to the city's catering service enterprises was issued. Opened a food and drug safety work briefing platform for food and beverage, and published more than 2,300 food and drug safety newsletters.
Implement responsibility, highlight key points, and comprehensively supervise the whole process of drug and machinery safety.
Highlight source governance. GMP tracking and inspection of pharmaceutical companies such as Global Pharmaceuticals and Tushan Pharmaceuticals will strengthen the supervision of key high-risk enterprises such as urban pharmaceuticals, and timely deal with problems in production and quality management. Organize the re-examination of the qualifications of the anesthetic drugs and psychotropic drugs management enterprises, and carry out special inspections of the compound preparation containing ephedrine.
Strengthen circulation and rectification. We carried out a special inspection on the license renewal of medical equipment, and inspected 41 enterprises that need to change their licenses; re-implemented gsp identification for six pharmaceutical wholesale enterprises and gsp identification for 66 retail pharmacies. Strengthen the monitoring of illegal advertisements. From January to September, a total of 10,102 fake and illegal drug advertisements were monitored, all of which were handed over to the industrial and commercial department for processing. The training practitioners had 458 people in 7 sessions and organized 1052 physical examinations. 3,820 reports of adverse drug reactions were reported. Promote the "two networks" upgrade, this year added 34 medical institutions "standard pharmacies."
Strengthen medical device supervision. Conducted special inspections of high-risk medical device operators, and inspected 54 high-risk medical device operators; inspected 2 custom denture manufacturers, and logged out 5 medical device business licenses, and banned one unlicensed contact lens business . 62 medical device adverse event monitoring networks were established, and 657 medical device adverse events were reported.
Heavy punches and fakes. Up to now, a total of 82 cases of drug-related machinery have been investigated, including 81 drug cases and 1 device case, and 2 unlicensed business households have been banned; 74 varieties of counterfeit drugs and medical devices have been destroyed, with a value of 57,000 yuan; 11 complaints were reported and all were promptly checked and reported to the complainant, and one of them was investigated and investigated. The city has sampled 597 batches and has completed 539 batches of inspections.
Strengthen emergency response. A comprehensive plan for the prevention and control of influenza A (H1N1) was launched in response to the emergency response plan for influenza A (H1N1). Organize pharmaceutical machinery enterprises to implement the production, procurement and storage tasks of emergency medical equipment, carry out special supervision and inspection of production, operation and use units of emergency medical equipment, work on strict duty and leadership system, and respond to the city's response to influenza A (H1N1). The epidemic provides quality and safety and reserve guarantee for the prevention and control of medical devices.
Change concepts, do a good job, and promote the steady development of the pharmaceutical economy.
The full implementation of the “Revitalization of Peony Drug Action Plan” has achieved remarkable results. The China Medical News has specifically interviewed and reported to the city. Adopting the analog identification method, the enterprises that need gmp identification should be involved in advance, and the enterprises with weak management foundation should be stationed in the enterprise to help and guide the enterprise rectification. This year, the identification projects of the identification enterprises in the city in the national and provincial identification inspections are significantly less than last year. Up to now, 12 production lines of 6 enterprises in the city have passed the national and provincial gmp identification and inspection. Actively coordinate with the provincial bureau to help Fufengyuan Tushan Pharmaceutical Co., Ltd. solve practical problems such as registration of soft bag packaging materials and supplementary application for drug packaging changes. To help solve the problem of the reorganization of Fubo Pharmaceutical Chemical Co., Ltd. and Tushan Pharmaceutical Factory, the 8,000-ton paracetamol drug substance project was successfully identified by gmp. Helping 蚌埠泰生物股份有限公司 to obtain a drug production license, the city has added a large-scale pharmaceutical production enterprise. Under the specific guidance of our bureau, Qingda Deren Brain Health Therapy has obtained the product registration certificate and the product has been listed. Regularly hold seminars on drug wholesale business management to help companies adjust their business ideas and continuously expand drug sales channels. Build an independent innovation platform and actively promote the transformation of scientific and technological achievements. The national first-class drug, etoxoxacin hydrochloride, developed by Global Pharmaceuticals and the Shanghai Institute of Materia Medica in the Chinese Academy of Sciences, is China's first quinolone anti-infective drug with completely independent intellectual property rights. It was officially launched into the market in July, which is also the city's autonomy. One of the major achievements of innovation. Organize the industry, academia and research matchmaking meeting, and reach five agreements and intentions such as scientific research transformation, joint research and development, and solving production technical problems. This year, the total drug sales in the city has grown by 20% over the same period last year. The output value of the pharmaceutical industry is 700 million yuan, and the sales income is 680 million yuan, up 20% and 30% respectively over the same period of last year; the profit and tax is 90 million yuan, more than double the same period of last year. In the context of the financial crisis, the city's pharmaceutical economy has maintained rapid and healthy development.
Since the beginning of this year, all the work of the bureau has been carried out in a solid and effective manner. The municipal government has achieved excellent results in the assessment of the objectives of the city. It has successively won the city's advanced units for legal administration and the use of academic law, the advanced units of the party committee's information work, and the construction of the rural "two networks" in the province. Honorary title of work advanced unit. At the same time, the Fujian Food and Drug Inspection Center was actively established. The municipal government held a coordination meeting of relevant departments for four consecutive times to conduct a special study on the construction of the food and drug inspection center. At present, the project site selection and construction funds have been basically determined.
Second, XX year work ideas and arrangements
In XX years, with the guidance of the scientific development concept and the Fourth Plenary Session of the Party's XX Session, the bureau will continuously improve the food and drug supervision capabilities and comprehensively guarantee the safety of people's diet and medication in our city.
Actively perform new duties of supervision.
In combination with the characteristics of catering consumption in the city, the short-term and medium-term goals of catering unit rectification will be formulated. Strict licensing conditions, refine the review criteria, and further standardize the acceptance, review, approval and certification of licenses and instruments. Efforts were made to carry out special rectification activities for unlicensed and unlicensed business households with fixed business places, and to establish small food and beverage demonstration points as a means to play a leading role in demonstration sites. Increase the supervision and disinfection of tableware, increase the intensity of food sampling, implement rapid inspection methods, and expand the coverage of inspections. Cooperate with relevant departments to carry out special inspections of various canteens. Do a good job in catering safety protection for all major events; strengthen laws and regulations training, standardize law enforcement behaviors, standardize the business operations of catering service industry; actively cooperate with relevant departments to do food poisoning investigation work; do a good job in investigating illegal activities of catering service enterprises according to law . Organize the safety supervision of health products and cosmetics, strengthen the daily supervision and guidance of health products, cosmetics production and management enterprises, and do a good job of rating the cosmetics and health food production enterprises in the jurisdiction. Carry out health food, cosmetic safety evaluation and adverse reaction monitoring.
Keeping the pressure of the drug regulatory supervision is not lax.
Strengthen the dynamic supervision of pharmaceutical production enterprises, adopt a combination of follow-up inspection, flight inspection and special inspection to supervise and inspect all pharmaceutical production enterprises in the city, with coverage rate of more than 100%, and focus on the supervision of injection production enterprises. The frequency of inspections reached 3 times. Special inspections were carried out on three pharmaceutical packaging materials manufacturers such as New Huangshan Glass Co., Ltd. Strengthen daily supervision and inspection of products entering the national essential medicines catalogue. Supervise and help companies to do gmp identification and re-identification work. Carry out drug re-registration work. We will further promote the production process and prescription verification work, strengthen the supervision of the production of high-risk drugs, and strengthen the dynamic supervision of the city's hemp drugs.
Strengthen the management of drug purchase and sales channels, and rectify illegal and illegal behaviors such as “joining operations” and “walking tickets” in the circulation of drugs. Standardize the circulation order of Chinese herbal medicines and Chinese herbal medicines. Establish records of bad behaviors of pharmaceutical and medical device companies and make them known to the public. Implement a more rigorous product recall system. In conjunction with the industry and commerce departments to increase the investigation and punishment of illegal drug medical device advertising, focusing on monitoring and combating the use of the Internet to publish false advertising and false publicity. Establish a national essential medicine production supply and quality assurance mechanism. Carry out special inspections on the quality of anti-control H1n1 influenza drugs. Carry out special inspections on the quality of medicines and medical devices in medical institutions, strengthen the monitoring of adverse events of medical devices and emergency management of drug safety, improve the emergency plan for emergency incidents of medical devices, and establish and improve the daily supervision files of medical device manufacturers.
We will maintain the anti-counterfeiting and high-pressure situation, strengthen the operation and management of drug testing vehicles, and do a good job in sampling inspection. Improve the monitoring network for adverse drug reactions and medical device adverse events, and improve the quality of case reports.
Promote the healthy development of the food and pharmaceutical industry.
Actively help pharmaceutical companies solve problems and problems, actively reflect the needs of pharmaceutical companies in development, and coordinate relevant departments to optimize the external development environment of pharmaceutical companies. We will increase the assistance in drug registration and production, and actively support the pharmaceutical production enterprises in our city to enter the national essential drug catalogue into the national designated production. Increase the support of independent innovation enterprises. Through the implementation of measures such as drug gmp management and quality system assessment system, we will comprehensively improve product quality and safety standards and enhance core competitiveness. Promote the integration of academic research institutions and enterprises. Encourage enterprises to establish a number of key laboratories, technology research and development centers, pilot test bases, clinical research bases, etc. with the Pharmacy Department of the Affiliated Hospital of Fujian Medical College, Fengyuan Medical Technology Development Co., etc., to build a platform for technology development and innovation, and accelerate products. R&D and innovation. Actively explore and standardize the catering industry, health food, cosmetics industry, promote the chain operation of the catering industry, and standardize services. We will introduce health food and cosmetics production enterprises, cultivate health-related industries, and strive to promote the development of the food and medicine economy in our city.
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