Medical news network February 28th February 27th at 10 in the morning, the State Council Information Office held a press conference, director of Food Safety Office of the State Council, the State Food and drug administration secretary Bi Jingquan introduced the food and drug safety supervision work in our country, and a reporter asked.
In the Q & a session, Bi Jingquan introduced the new year to deepen the reform of the medical device examination and approval of the seven key aspects of the reform of the system:
First, to speed up the work of drug quality consistency evaluation. In order to expand the resources of clinical trials and explore the methods for the evaluation of the quality and consistency of injections, the re evaluation of the safety and efficacy of Chinese medicine injections should be initiated.
Second, encourage drug innovation. To encourage research in pharmaceutical innovation policy, improve the drug professional links and data protection system, and to achieve international recognition of clinical data outside the territory, reduce the cost of research and development of enterprises.
Third, to establish a technical system of drug and medical device approval review leading, we should continue to increase drug medical devices evaluation personnel and inspection personnel, and gradually form a technical evaluation as the core, on-site inspection and inspection of products for the evaluation of technical support and approval mechanism.
Fourth, the responsibility of the implementation of on-site inspection. It is necessary to strengthen the on-site inspection of the clinical trial of medical equipment and the on-site inspection of the production process, to strengthen the verification of the authenticity of the data, to clarify the legal responsibility of the inspectors and the supervision responsibility of the inspection units.
Fifth, the establishment of drug varieties file. It is necessary to set up a database for each listed drug, including the prescription of drugs, raw materials, packaging materials, quality standards, specifications, post marketing safety information, production process changes and other information. Because of the history of the approval of the drug, the requirements of different ages are not the same, so some of these files are missing, and some enterprises to adjust the process of adjustment is not timely approval or filing.
Sixth, to establish the drug electronic common technical document system (eCTD system), to the end of this year can be achieved according to the new system to implement electronic filing and review, so that it can reduce enterprises, especially in the overseas enterprises to declare to declare China requirements basically is a kind of format is the same, reduce the burden on us.
Seventh, to speed up the process check. Pharmaceutical production enterprises must be produced in accordance with the state approved process. According to reports, the views of the process check, CFDA is based on various aspects of the proposal to revise and improve, as soon as possible for the issuance.
The common name for Chinese medicine guidelines outside attention "(Draft), I Izumi said that the naming of proprietary Chinese medicines, the focus is to rectify the exaggerating efficacy, efficacy and vulgar language suggested naming. For the name of the case is not standardized, will be combined with the standard to improve the registration and other work gradually standardized, really need to modify the name, will give a certain period of time to gradually transition.
The text.
Host attack:
Ladies and gentlemen, good morning, welcome to the press conference of the State Council Information office. Recently, the State Council Information Office invited a series of ministers to attend our conference. We are very happy to invite to the director of Food Safety Office of the State Council, the State Food and Drug Administration Director Mr. Bi Jingquan, ask him to introduce food and drug safety supervision work in our country to you and answer your questions.
Now, please introduce mr..
Bi jingquan:
Dear reporter friends, hello. I am very pleased to attend today's press conference, first of all, I would like to thank the friends of the press on food and drug regulatory work of attention, concern. Food and drug related to the vital interests of the overwhelming majority of the people, but also the most basic livelihood issues, is an important symbol of building a moderately prosperous society in an all-round way. CPC Central Committee and State Council attach great importance to food and drug safety. General secretary Xi Jinping, Premier Li Keqiang has repeatedly stressed that the party committees and governments at all levels and relevant departments to fully carry out the food and drug supervision work, to adhere to the most stringent standards, the most stringent regulation, the most severe punishment, the most serious accountability, strict every line from farm to table, from the laboratory to the hospital the masses of the people, to ensure the safety on the tongue".
Over the past year, food and drug supervision departments at all levels to vigorously promote the "management services" reform, problems out of the use of prohibited agricultural veterinary drugs and food additives in food focus on remediation, heavy combat counterfeiting and selling illegal drugs and medical devices, review and approval system reform and innovation mechanism, steadily implement generics quality consistency evaluation of curative effect, comprehensive public supervision and law enforcement carry out the food safety information, create a good environment to create a city, food and drug safety. However, there are still many problems in the field of food and drug safety, regulatory work and the expectations of the people there is still not a small gap, food and drug safety situation is still complicated and grim.
Not long ago, the central financial work leading group of the fourteenth meeting to make arrangements for the work of food safety; the State Council issued the "two plan" in 13th Five-Year food safety and drug safety, the general office of the State Council issued a notice of the drug production and distribution policies, the State Council food Safety Committee held a plenary meeting on food safety key. Last year, the National People's Congress to carry out the food safety law enforcement inspection, the CPPCC National Committee held a biweekly consultation forum to discuss the construction of food safety supervision system. All walks of life, especially the media friends have given a lot of support, these are our food and drug safety work is a strong guarantee.
The new year, we should adhere to the overall tone while maintaining stability, strictness, severe punishment, prevent, strict management and strict control of food and drug safety risk. Hold to "hand", around the people's common concern, carrying out the outstanding problems in the regulation, quality and safety inspection, to prevent systemic risk in the field of food safety, drug safety crackdown on counterfeit criminal acts, concentrate on investigating major cases. To fight the battle, the implementation of quality and safety of food and beverage industry promotion project, and vigorously promote the generics quality consistency evaluation of efficacy, to encourage the development of new drugs, speeding up the construction of occupation of inspectors, to regulate the supply side structural reform innovation service. Food and drug safety work for the people, rely on the people, we sincerely hope that all sectors of the community to participate in a wide range, with the regulatory authorities to work together to share food and drug safety.
Now, I would like to answer your questions.
Host attack:
Thank you very much for your brief introduction. Below we will enter the question and answer session, in accordance with the practice, please notify the news agency before the question.
CCTV news reporter:
I would like to ask a question. The overall stability of China's food security situation is good, but the pesticide veterinary drug residues and fake and adulterated food products and other issues still let people tangled. I would like to ask the secretary how to protect the security of the tongue, so that people eat more secure, rest assured it?
Bi jingquan:
We must have confidence in China's food safety, but also to see gaps and problems. We say that we must have confidence, one is the result of sampling from the market point of view, food safety is guaranteed. 2016 food and Drug Administration organized sampling of 257 thousand batches of food samples, the pass rate of 96.8%, unchanged from 2015, compared with an increase of 2.1 percentage points in 2014. We have more than 1300 large-scale production and operation of enterprise sampling test, the pass rate was 99% and 98.1%, in recent years, no significant systemic food safety incidents.
From the point of view, all aspects of the efforts to further increase, in 2016 issued a new national food safety standards 530, involving food safety index of nearly 20 thousand, the new pesticide residue limit of 490, the number of sampling inspection of food increased by 49% over the previous year, a year is 170 thousand batches, 2016 257 thousand batches. The results of our weekly open food sampling, the unqualified products in a timely manner to take off the shelf, recall and other measures to eliminate the risk. The food and drug regulatory authorities to investigate 170 thousand cases of illegal food, public security organs and investigated 11 thousand cases, a powerful deterrent to offenders. We strictly implement the territorial responsibility for food safety management, and seriously deal with dereliction of duty dereliction of duty. In addition, the implementation of the new food safety law, the establishment of a unified authority of the food and drug regulatory system, Party committees and governments at all levels to increase food regulatory inputs, which are for the food safety work provides a legal guarantee, system guarantee and important guarantee of funds.
At the same time, we want to see the gap and problems. Due to the special situation of our country and the historical development stage, the situation of food safety is still complicated and grim. There is still a big gap between the food safety and the people's expectation. Such as pesticides and veterinary drug residues exceed the standard risk, the risk of heavy metal exceed the standard of food caused by environmental pollution, grain storage risk fungal contamination in transportation, and illegal to add non food substances, the risk of food additives super range, ultra limited use. In addition, counterfeit, adulterated, fake violations still occur.
In the regulatory work, we have a lot of gaps in the standards of food safety, regulation, punishment, accountability and other aspects, grassroots regulatory power is weak, lack of professional and technical personnel, some facilities and equipment behind. These are not suited to the needs of regulatory work. The existence of the gap is the direction of our efforts, food safety is not zero risk, but the food safety crimes must be zero tolerance". We have the determination and confidence in accordance with the general secretary Xi Jinping put forward the "strictness" requirements, strict management, to prevent and control food safety risks, problems concerned and make great efforts to improve the people's common, earnestly implement the local territorial management responsibility, strict from farmland to each line of the table, do the maintenance people safe tongue". Thank you
Phoenix TV reporter:
Infant formula milk powder has been a key part of our nerves. At present, the mainland infant milk powder from the record system into registration system, there are a lot of comments that this will have a major reshuffle of the industry, do not know how to look at this problem? In addition, the next step in the food and Drug Administration in terms of infant formula? Thank you
Bi jingquan:
Infant formula milk powder is the lack of breastfeeding in infants due to various reasons under the condition of alternatives, so it is directly related to the growth and health of infants. There has been a painful lesson in history. The safety problem of infant formula milk powder quality is always the priority among priorities of food supervision, strict supervision from the source, production and sales of the factory to implement the whole process.
First, strict control of the source. Self milk base production enterprises, we encourage the infant formula milk powder, not self milk base to have a stable raw material supply channels and regular review. Implementation of raw materials into the factory batch inspection responsibility, guarantee the quality and safety of infant formula milk powder from the source.
Second, strict management process. Companies to strict production management environment, operation process and equipment running status of equipment, enterprise to infant formula milk powder factory products are all project batch inspection, enterprises should establish the whole process of production and operation of the traceability system and product tracking and evaluation standard. From 2014 to now, the food and Drug Administration launched the 60 infant formula milk powder production enterprises of food safety standard system inspection, and to the social public examination results, the deficiencies found in enterprise rectification.
Third, strict inspection of products. Our factory inspection Pipi whole project based on enterprise, supervision departments to carry out special supervision and sampling inspection of infant formula milk powder, adhere to the "monthly sampling, monthly open", to achieve the production enterprises and inspection project two full coverage.
Fourth, illegal punishment. The inspection found unqualified products and enterprises, regulatory authorities to take immediate measures under the framework of recall, discontinued rectification, illegal and criminal acts severely punished fake brands of infant formula milk powder.
Overall, the level of quality and safety of infant formula milk powder of our country is in a steady increase in 2016, sampling a total of 2532 batches of infant formula milk powder, found substandard batches of 32 samples, accounting for 1.3%, this does not meet the national food safety standards, there are security risks of unqualified samples 22 batches, accounting for 0.9%; do not meet the packaging system, packing label unqualified sample value, but there is no food safety risk of 10 batches, accounting for 0.4%. The detection problem basically are small and medium-sized enterprises, so the infant formula milk powder production of large enterprises basically found no unqualified samples.
According to the relevant provisions of the food safety law, food and drug administration started the registration of infant formula milk powder, this is the special supervision measures of China's infant formula milk powder food and special status, focus on remediation brand and formula of excessive, improper labeling and advertising label improper publicity problem. Infant formula milk powder function claim must go through scientific experiments confirmed that the prohibition of express or implied, such as puzzle, enhance immunity and false propaganda. Thank you
People's daily reporter:
At present, the table food safety has been more and more attention of users, takeaway food safety incidents have been repeatedly exposed, I ask the Secretary in charge of food and beverage safety supervision departments will take what measures? Thank you
Bi jingquan:
It is now more and more common for residents to dine out, to promote the quality and safety of food and beverage industry to enhance the level of concern to millions of households.
Enhance the quality and safety of food and beverage industry, which should be divided into the main responsibility of the enterprise and local government oversight responsibilities. For enterprises, to implement the four responsibilities:
First, the purchase of raw materials quality and safety responsibility. Catering enterprises should establish a stable supply channels of raw materials, to ensure the quality of raw materials purchased in line with national food safety standards, the implementation of the risk self-examination system. For example, the purchase of pesticide residues, veterinary drug residues exceeded raw materials, catering enterprises themselves to be responsible for.
Second, earnestly implement the relevant standards of food and beverage industry responsibility. Cleaning and processing of raw materials, tableware, kitchen utensils, drinking utensils and related tools for cleaning and disinfection to comply with the norms of food and beverage operations, to ensure the separation of raw and cooked to prevent cross contamination.
Third, the implementation of the "bright bright kitchen stove" responsibility, to allow consumers to see the production process and the health status of the kitchen, can take the glass wall, can also take the camera monitoring method, a few screen on the outside.
Fourth, to implement the utilization and harmless treatment of the responsibility of kitchen waste, to prevent the "drainage oil" "swill oil" flow to the table. The first responsibility of the responsibility is the legal representative of catering enterprises, to large catering enterprises clear food safety regulatory responsibility department stores to food safety administrator, catering staff to participate in regular training and examination, physical health must comply with the relevant provisions, the main responsibility is the enterprise should bear up.
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