Xinhua News Agency:
Minister Bi, how should we comment on the current level of safety and quality of domestic infant formula? What should we do to improve consumer confidence in domestic products? Thank you.
Bi Jingquan:
Infant formula is the most supervised product of the food safety supervision departments. Article 81 of the new version of the Food Safety Law of the People's Republic of China has stipulated that enterprises producing infant formula shall implement full-process quality control from incoming materials to outgoing finished products and inspect the outgoing infant formula batch by batch so as to ensure food safety. This is a stipulation of the Food Safety Law specifically targeting enterprises and is also a duty they have to comply with.
Overall, infant formula is reliable in quality and safe for use. At present, there are 103 enterprises that produce infant formula all over China. In 2015, we carried out a nationwide spot check on all the domestic infant formula products and some imported products in nearly 3,400 batches. With the testing items covering what's required by the state food safety standards, we found 94 batches of unqualified products. Among them, 36 batches had food safety risks since some indicators did not meet standards, accounting for a bit more than one percent of the total sampling. The remaining 58 batches failed the spot check due to their unqualified package labels rather than quality problems. All the details of this spot check have been posted on the official website of the CFDA. Local food and drug administrations have also recalled all the products which had food safety risks, asked some enterprises to suspend production for rectification and recalled those unqualified labels.
Nowadays, products from small enterprises, particularly those that produce goat milk powder, are found to have more problems. During what we called a food safety audit, we conducted a systematic check on their production system and pointed out their defects concerning their management system of research and development, production and testing. On Feb 26, the CFDA issued a notice on the systematic problems of 17 enterprises at its official website and asked them to rectify problems and reform.
This year, we will enhance the supervision of infant formula by increasing the spot check frequency from quarterly to monthly. We will continue to strengthen the inspections on production systems and strictly control the amount and brands of infant formula food. Meanwhile, we will prohibit producers from exaggerating the effects of formula to mislead consumers.
Bloomberg News:
The SFDA put out a guideline on Friday, saying it will accelerate the approval process for drugs that need certain criterion including new drugs for diseases like cancer and hepatitis. Given that there is public concern around diseases like hepatitis and there are lots of these types of drugs in the world, can you tell us what the time frame will be for foreign companies applying for approval in China, and how long it will take to get the SFDA's approval? Thanks.
Bi Jingquan:
It is really an arduous task for the SFDA to address the overstocking of drug appraisals and approvals. There used to be as many as 32,000 application files waiting to be processed. At the end of 2014, the SFDA started the reform on drug appraisal and approval system. In August 2015, the State Council issued an opinion, suggesting that the approval standards for medicine should be improved, that the consistency in the evaluation of generic drug quality and efficacy should be advanced, and that a program on marketing authorization holders should be piloted. So far, all these suggestions have been put into practice.
As for how long it will take to approve certain drugs, I'm afraid Ican't give you a time frame. However, I'm certain it will be shorter than before. The amount of applications we processed last year increased by 90 percent over those processed in 2014, and the amount of unprocessed drug applications decreased substantially. In regard to approvals concerning the clinical trials of drugs, the new drugs had to pass three rounds of appraisal when it comes to phase III, but now the second and the third rounds will be substituted by a meeting after the first round. The procedure will enter into the next stage if approvals were confirmed at the meetings. Applications for clinical trials of generic drugs will be applied to the filing system rather than the appraisal and approval system. All these measures have tremendously improved the efficiency of drug appraisal and approval.
The guideline on accelerating drug approval issued recently listed the drugs that shall be granted priority review, including the drugs mentioned by the journalist with Bloomberg. We also adopted some priority policies and measures for those drugs, including the meeting communications between the applicants and our review staff, reducing clinical study cases required in regard of rare and special diseases, and allowing innovative drugs for life-threatening diseases that lack effective treatments to enter the market conditionally before the phrase III clinical trial.
In the guideline on priority appraisal and approval, the responsibilities of the reviewers and applicants are clarified and a clear timetable is set for these drugs' application reception, appraisal, examination, and on-site verification. It also requires the review staff to inform the applicants about supplemental materials, and lists certain punitive measures to deal with fraudulent activity concerning the authenticity of application materials. This means we need to build a more professional appraisal team. There are more than 5,000 reviewers in the United States' drug appraisal and approval center, while we only have about 130 on-post reviewers. What makes the situation worse is that we are losing key members in recent years. In the past three years, about one third of front-line reviewers left for enterprises where they could be paid as high as ten times that of the salary they received previously. What we target are the edged research advantages produced by high-tech enterprises around the world. That means we have to recruit first-class scientists, especially experienced doctors, to lead the review of new drug applications. Additionally, our reviewers should be able tosympathize with our country's specific circumstances, namely, a large population, consumption rate and pharmacy. What we face are not only Chinese high-tech enterprises, but also the ones from other countries. The State Council has asked us to outline policies to ensure recruited reviewers can work here for a long time. We are considering to reform the drug appraisal and approval system and adjust the drug review organization system, and we are determined to guarantee the safety of the drugs throughout the reform. Of course, efficacy is more important.
To be honest, I don't dare to imagine the expansion of our review staff to 5,000, similar to the scale of the FDA in the United States. Even if we were allowed to recruit 1,000 to 2,000 reviewers, it would need to be done step bystep. To sum it up, it is time to address the low efficiency in drug approval and we will exert great efforts towards this goal.
Guo Weimin:
The SFDA is working tirelessly to address this issue, and of course some problems have to be taken care of. Next question, please.
Phoenix TV:
Mr. Bi, we learnt from a recent university research report that in Jiangsu and Zhejiang provinces, as well as in the Shanghai Municipality, antibiotics for animals were discovered in many children's bodies. These medicines are likely to cause obesity. Compared with them, antibiotics for humans are not so closely related to obesity. What's your response to this issue? Besides, how serious is the antibiotic residue in China? Thank you.
Bi Jingquan:
This is the latest news, which was just released and has attracted great public attention. Whether pesticides and animal antibiotic can cause obesity among children is a scientific issue and needs to be further studied by scientists.
I'd like to answer this question from the perspective of the food and drug supervision department. Currently, in the food safety field, the residue of pesticides and animal medicine is seen as the biggest risk, which is understood as chemical risk. It can't be seen or felt by consumers. In contrast, biological risks, such as the decay of foods, are often visible. Additionally, Chinese people tend to cook foods using high temperatures. This practice can kill almost any bacteria. However, people are unable to detect the residue of pesticides and animal medicine. Nor can they get rid of them when consuming the foods. Therefore, the residue of pesticides and animal medicine is always a very important issue for the food and drug supervision department.
In 2015, more than 40,000 batches of food were selected to undergo inspections for residue of pesticides and animal medicine. They accounted for about one quarter of all the foods we selected for inspection. Of them, 225 batches were found to have excessive residues. A few days ago, we released a special notice on this issue.
Systematic approaches need to be taken to solve the problem. There should be professional personnel and machines. Many of our staff didn't study the related subjects at school. Their knowledge in this field is insufficient. They also need training to improve working skills. In this field, we have a lot of work to do. That's why I reiterated in many occasions that we should establish a professional inspection team to carry out food and drug supervision tasks. We can't mistakenly think that inspection only involves watching, touching and smelling. It is not making tours around markets.
According to the Food Safety Law, food producers should undergo required inspections when purchasing raw materials. Regarding animal derived foods, such as pork, beef, mutton, poultry, eggs and aquatic products, inspections should be conducted on raw materials and finished products. Food sellers also need to receive inspections when they purchase new stocks. They should be held fully and legally responsible for the residue of pesticides and animal medicine in the foods they sell.
As for the food and drug supervision department, regular supervision on producers and sellers, and sample inspection on products available in the market should be intensified. When products are discovered to have excessive residues, their producers must be found out. A few days ago, the State Council released a document on establishing a product tracing system. This is stipulated explicitly in the Food Safety Law. It's an enterprise's responsibility to make its products traceable. In addition to making inspections in the market, we need to address the origin of the problem.
General Secretary Xi has required us to accelerate the establishment of a unified, authoritative food and drug supervision system. He has also required us to establish the toughest standards, conduct the strictest supervision,make the harshest punishments and hold all concerned accountable to ensure food safety. Premier Li Keqiang also required us to speed up the development of specific opinions on improving various systems and work harder to improve the supervision systems at the state level and various local levels.
Currently, we are working with all departments concerned to implement these orders. Taking this precious chance, I'd like to ask the Communist Party of China (CPC) committees and governments at all levels to pay attention to the reform of the food and drug supervision system. Great importance should be attached to the requirements repeatedly made by the 18th CPC Central Committee at its second and third plenary sessions, and by the central government. Efforts should be made to accelerate the integration of government functions. A unified, authoritative supervision organization should be established with corresponding functions and powers. Only in this way can our needs in law enforcement be met.
As for obesity among children mentioned in the report, relative departments have begun to verify it. You may receive updates on it soon.
China National Radio:
Mr. Bi, based on our previous interviews we found a number of food manufacturers and processing assembly lines had packaged outdated food by changing or erasing their production dates. Moreover, they may also process expired food for a second time for sales. What are the government's measures to supervise and regulate the market that has been devastated in this way?
Bi Jingquan:
To process expired food as raw material for a second time or surreptitiously change the production dates in order to sell the outdated food again in the market are all criminal offenses offering expired products as qualified ones. The law violators will, therefore, be prosecuted for criminal liabilities. There is a well-known lawsuit, namely, the Shanghai Fusi Food. The People's Court in Jiading District, Shanghai, reached a verdict on Feb. 1 by sentencing a fine of 1.2 million yuan to Fusi Food suppliers in both Shanghai and Hebei Province. Ten defendants involved in the lawsuit were sentenced to be fined and imprisoned over a certain period of time. We hope that legal representatives, managers and quality supervisors from the food manufacturing and processing sectors can learn from the example of Fusi Food and do not touch the high-voltage wire of the law.. The manufacturers and sales representatives should work with conscience.
The supervisors from the administrative departments should scrutinize the overall process of food manufacturers and launch regular exams on enterprises' food sales. They should start investigations no later than when a problem has emerged and send relative suspects to judiciary organizations to check their criminal accountabilities. We also welcome every individual in society to report these criminal behaviors to food supervision administrations as soon as they become aware of them.
