From the local government, to implement the responsibility to strengthen the supervision and inspection of food and beverage industry raw material stock, must be severely punished in violation of food safety laws and regulations, in violation of the norms of operation behavior of catering. At the same time, to strengthen the school, kindergarten canteens, rural collective dining, tourist attractions, railway catering and other food safety supervision, to prevent the occurrence of mass food poisoning.
Here I would like to specifically on the network ordering problem for a response. In 2016 the food and Drug Administration issued a "network of food safety violations investigation measures", the focus is: first, only licensed entity restaurants can accept ordering online, no entity shop not in online sales of food products, food and beverage companies must ensure the sales network in the food and beverage products in the store sales and catering the quality of the products is consistent.
Second, we must strictly implement the network catering services third party platform responsibility, the third party platform to achieve three guarantees: one is ensure that show on the platform in the catering business license is real, so as to ensure that the operators must be offline store instead of the black workshop. The two is to ensure that in the delivery process of food is not contaminated, because the company is the third party logistics service platform selection and designation, so in this respect should assume regulatory responsibility. The three is to ensure that the consumer complaints get timely treatment, because the consumer is in the third party platform ordering and payment, the third party platform for settlement. Therefore, the platform to do these three operators to ensure.
Third, we must strengthen the supervision of network catering services. Regulatory authorities should strengthen the supervision of the third party platform and food and beverage enterprises under the line, promptly investigate violations of the above provisions of illegal acts. We welcome the masses of consumers and the media to supervise the online meal ordering. Thank you
Bloomberg News Agency reporter:
2017 drug review what the new policy will bring great impact on multinational pharmaceutical companies in Chinese what market access? Thank you
Bi jingquan:
Reform of medical device approval examination and approval system, which is the task of the Communist Party of China in the third Plenary Session of the 18th CPC Central Committee to deploy the reform. In August 2015, the State Council issued the opinions on the reform of the medical equipment examination and approval, marking the full start of reform. This reform is mainly around the improvement of quality, solve the backlog, optimize the service of three objectives.
For more than a year, the curative effect of generics quality consistency evaluation work in full swing, a number of new priority listing, authenticity and reliability of clinical data verification has achieved preliminary results, drug marketing authorization holder system carried out in ten pilot provinces and cities, scientific and efficient system of drug and medical device review and approval system preliminary formation, adaptation in the review, review and review team member conference communication, the expert advisory committee of a public demonstration to solve the major differences of system have been established, review and approval of drugs has begun the implementation of the results to the public.
The number of people working for drug reviewers increased from 120 people two years ago to the end of last year to more than 600. The number of applications for registration of the backlog has been from 22000 at its peak in 2015 dropped to about 8000 now.
In the new year, we must continue to deepen the reform of medical device medical examination and approval system reform, a comprehensive solution to the backlog of contradictions, and further stimulate the vitality of the pharmaceutical industry, there are seven key areas of work.
First, to speed up the work of drug quality consistency evaluation. Because, in the China generics on the market or clinical subject, we should expand the clinical trial resources, quality and efficacy of injection method to explore the consistency of evaluation, and evaluation to start the safety and effectiveness of drugs of traditional Chinese medicine injections.
Second, encourage drug innovation. We should 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. We need to build up a database for each of the listed drugs, including drug prescriptions, 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 in accordance with the national approval of the production process, the process of verification of the views, we are in accordance with the recommendations of various aspects of the revised and improved, as soon as possible to issue. Thank you
Beijing News reporter:
In 2015, China began the consistency evaluation of generics for this work, people may still not understand, want to please Bi TA to introduce it to the people to bring benefits, as well as its objectives and are now in the process of. Because now many people worry that the task is so heavy, can be completed on schedule? Finally, there are a lot of people questioned, to carry out the consistency of generic drug evaluation does not mean that there is a problem in the quality of drugs, please respond. Thank you
Bi jingquan:
The consistency of the evaluation of the quality and efficacy of the approved generic drugs, this is the 2012 January the State Council issued the "12th Five-Year proposed" drug planning tasks, in 2015 the State Council issued the "on the reform of drug and medical device review and approval system" reiterated this request, so this work is not a new proposed. In the past, we have not approved the listing of drugs and the quality of the original study of the efficacy of the consistency of the requirements, not mandatory requirements, so there are some drugs on the efficacy of the original drug and there is a gap. The purpose of the evaluation of the consistency of the quality and efficacy of generic drugs is to make our production of generic drugs in clinical practice and the original drug alternative. The advantage is that it can reduce the burden of medical expenses and improve the international competitiveness of Chinese pharmaceutical enterprises.
The quality of Chinese medicine to a historical perspective, the development of view, according to today's standards to look at more than a dozen years ago, decades ago approved drugs, we will feel this or that problem, this is normal. Our country has experienced underserved age, if the past our main problem is to resolve the problem of "shortage", "no", so now our main problem is to solve the quality problems, to solve the problem of "good".
So we put forward innovative drugs to "new", not how to call new innovation, improved drugs to "excellent", to improve their product from certain clinical advantages than the original people of the new drug is more, or why you want to improve? Generics to "the same", that is the quality and effect, since the imitation of others things, then you should be able to agree with others, is in the active ingredients, dosage form, dosage, specification, medication should have the same treatment effect should be the same, can be substituted for each other, this is generic. Therefore, our reform is to make our pharmaceutical companies, pharmaceutical industry to be able to move towards an innovative development track. Now the enthusiasm of enterprises to participate in the evaluation of consistency is very high, generic drug consistency evaluation office has received a reference to the preparation of the filing of more than 4 thousand, the record variety of more than and 700.
We must strive to solve the clinical trial supervision department reflects the lack of resources of the enterprise, the reference preparation selection problem that is difficult to do the translation and publishing of all varieties of the consistency of the evaluation guide service work, in conjunction with relevant departments to study and formulate preferential procurement, Medicare reimbursement policies, create a favorable external environment for enterprises to promote consensus the evaluation of the work. Thank you
Reuters:
I have two questions. Last week, the Chinese government released a list of countries that could be reimbursed. I would like to ask how much the price of these drugs will be reduced, and the extent of the specific decline? In addition, I would like to ask whether the Chinese government has banned the use of an additive in flour
Bi jingquan:
The first question you should talk to the Ministry of human resources and social security questions are more appropriate, because the drugs of medical insurance reimbursement is the social security department, but you just care about is to enter the medical insurance directory which drug prices will decline. I think the price of the new drug into the reimbursement directory if the production, I would like to lower prices, it is only from the perspective of a spectator, from the point of view of the pharmaceutical industry. I think the price policy should be based on whether to enter the reimbursement directory to make a choice.
The second question, you just mentioned the azo ammonia additives, to be honest, this thing is too technical. As far as I know, in the food safety standards, the use of food additives standards, is now available, wheat flour additives in the limited value. If you are interested, contact our news department and ask them to answer your questions.
China Radio International reporter:
I would like to ask the Secretary, why to carry out the creation of food safety city activities? What are the highlights of the event during the 12th Five-Year? How to create a "13th Five-Year" during the activities and the people safe tongue further docking? Thank you
Bi jingquan:
To carry out the food safety of the city to create activities, is an important starting point or means to promote the implementation of the local government responsibility for food safety management, but also to a measure of the level of safety supervision. Food Safety Committee of the State Council has held a meeting for three consecutive years, the State Council leaders attended and delivered speeches to promote the work. Now, there are 67 cities to participate in the creation of the national food safety city, to participate in the creation of the city's Party committee and government on food safety work compared with the previous pay more attention, because it is a government action. Regulatory investment more, the regulatory system is more perfect, the satisfaction of the masses also increased. Compared with before the creation of the pilot cities, the number of food safety supervision on-site inspection increased by 28%, the amount of food inspection samples increased by 21%, the masses to create the work of the support rate of up to 95%. Therefore, the people are generally supported by the masses of food safety satisfaction has been greatly improved.
Here I would like to say to you, in 2017, we will participate in the creation of the city to create a safe meat, rest assured that the food supermarket activities. Now we are most uncertain is the pesticide residue in vegetables and fruits, meat, eggs and milk, veterinary drug residue in aquatic product, to be honest, I often speak to our colleagues, said the food safe and normal not satisfied, came back home and asked his family, ask the people around you, ask our friends and relatives now, to buy meat, buy vegetables can not be assured. I said, in general we should be assured, but you said do not worry is the reason, WeChat circle now often spread piece, what to buy home washing dishes, how to remove the water bubbles, pesticide residues. Therefore, we would like to create the city inside, we volunteered to participate in the sale of assured vegetables, selling assured meat.
The State Council has just passed the "13th Five-Year" national food safety planning pointed out that food safety standards and the developed countries there is still a gap between the international Codex standards, we also have some gaps, pesticide residues, veterinary drug residues and lack of relevant standards, the test facilities. In order to solve the problem of the most reassuring people, we encourage these large supermarkets to participate in the initiative to create, in strict accordance with the existing national food safety standards to detect pesticide residues, veterinary drug residues. Green food, organic food must conform to the related counter sales. When the time of the green food certification standard is what, when organic food certification is what standard, now set the counter sales, this is a good thing, we should encourage people to create a brand, but we should also be in accordance with the green food and organic food standards for inspection, to the reality, otherwise it is fraud. Therefore, the regulatory authorities will also participate in creating these supermarkets carry out strict supervision and inspection, so that they can be forced to participate in the creation of these supermarkets strictly stock clearance, strengthen the supply chain management, and promote the development of agricultural order, so that people can actually buy "meat" vegetables heart "". Thank you
Southern Weekend reporter:
Recently, the General Administration of the Chinese patent drug generic name of the technical code issued, is seeking advice. What is the purpose and significance of this opinion? The resistance? As we see in the community reflect some enterprises, such as Yunnan Baiyao said publicly that if a large number of traditional Chinese medicine name, will affect their hundred years to establish the brand and reputation, expected loss will be more than ten billion yuan. What do you think of this problem? There are comments after the end, the next step we will implement this provision?
Bi jingquan:
The name of the drug is part of the drug standards, due to historical reasons, some of the names of Chinese patent drugs exist exaggerated and implied efficacy, misleading consumers. For example, a drug called ", so you eliminate Xiaoaiping" what kind of cancer? If you eat this medicine to eliminate the tumor, the surgeons do not have surgery, scientists have anticancer drug research, go home to eat can cure Xiaoaiping got cancer? There are also some drug names have similar problems. The name, you say is not diverted? Not everyone has the ability to identify, not all doctors are able to introduce the knowledge of the drug in strict accordance with the drug instructions, especially at the grassroots level.
In 2014, the food and Drug Administration established science and technology group, devoted to the study of the characteristics and rules of Chinese ancient prescription named, drafting technical guidelines named Chinese medicine, a few months before publicly solicit views of the community, now has ended comments. We hear some different opinions, because they are openly expressed, and some of them are reasonable. We will carefully study the comments and suggestions. Standardize the naming of traditional Chinese medicine, the focus is to straighten out the efficacy of the treatment, suggesting that the efficacy and vulgar language naming, it is in line with the interests of the people. For the case of naming is not standardized, we will work together to improve the standards and then gradually standardize the registration, the need to modify the name, will give a certain period of time to gradually transition. Thank you
Beijing TV reporter:
Excuse me, the recent Internet rumors of Porphyra is made of plastic, followed by Beijing food and Drug Administration conducted a rumor. My question is how to make these wanton food rumors have a rest in the regulatory process? Thank you
Bi jingquan:
In the past, there have been false news reports of "stuffed buns". But what I'm going to say is that, like "plastic vegetables", I think it's a brain problem. You said, you eat the first found is plastic, but also eat second?
For example, more than and 10 years ago, I was in Beijing, a well-known foreign supermarket bought buns, when it is still relatively new, selling finished products. Go home to eat when the first bite, I found that there might be some soil, with the Northeast words called Ya Chen, eat one mouth, I just put the things away. To be honest, I did not think that large supermarket in our multinational companies to open, sell baozi dishes not actually wash, after all, is the root zone of the soil with chop stuffing wrapped in steamed stuffed bun.
You said that the use of plastic to do such a rumor can be a seaweed market, as if there is a video. First, the rumors, the food safety law which is clearly defined, to give the detention order punishment, to crack down on crimes of violence, this is. Second, US Food and drug administration has organized the media news department established a rumor alliance, friends of the press to play your role, find experts timely analysis, see this case is not possible. Third, but also to remind consumers to enhance the sense of judgment, do not blindly spread such rumors.
Of course, we also encourage stakeholders to be threatened by rumors of damage. The food safety law, media disinformation is to bear the liability for compensation, so we hope the media friends to participate in food safety social cohabitation, the most important is to monitor these false rumors, you also want to expose those fake behavior. The news media reported on the food safety must be objective and impartial, suggest that you try not to use the "poisonous food" and "carcinogenic" this rendering of the word, a good. Because food safety reports have to consider the safety of food itself, but also to consider the social impact of this report.
For example, the vaccine, fake vaccine, Shandong Ji'nan vaccine case is an illegal business case, is an economic crime. Another example of "false milk", "milk" in Shanghai and the case is used milk formula cans to the enterprise to the enterprise packaging simple low-cost high priced milk tank hardcover price. For example, zombie meat how to jump on the table, what is zombie meat? Which piece of meat is not on the body, which body is not stiff? Our Lady Mr from live pigs, cattle bite a piece of meat to eat? Can't describe the food we eat. So we want to expose the fake rumors, to expose and criticize, punish. But the reports must be objective and impartial, honest, not how to attract the eye on how to play the title. To be bluntly, because you do not curry favour by claptrap friends from the media, also want to consider when you have these critical reports of social responsibility. Thank you.
Host attack:
Thank you very much for your professional and very fresh answer, and thank you for attending today's conference. Again, at 3 o'clock pm today, Minister of transport Li Xiaopeng, also attended the conference on the introduction of the State Council introduced the situation, we also welcome you to attend.
This is the end of today's conference. Thank you again, mr.. Thank you
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