Guo Weimin:

Good afternoon ladies and gentlemen, and welcome to our State Council Information Office Press Conference. Food and drug safety has been an issue that has sparked wide concern both at home and abroad. We are delighted to invite Bi Jingquan, director of the food safety office with the State Council and head of the China Food and Drug Administration, to the meeting today to introduce relevant information and answer your questions.

Bi Jingquan:

Good afternoon, reporters. The principle of food and drug supervision is to both protect and promote public health. The Party's leadership and the State Council proposed to reform the food and drug supervisory system, integrating the supervisory powers, which belonged to the business, quality testing and food and drug administrative departments, to form the Food and Drug Administration, and to build a food and drug supervisory system extending from the central government level to the grassroots level, which is in charge of the unified supervision of food and drug safety at every link of their production and circulation, so as to safeguard the people's safety in this regard.

In the past year, the administration earnestly implemented the CPC General Secretary Xi Jinping's appeal of "the strictest standards, the harshest supervision, the heaviest punishment and the most serious accountability," as well as the work and reform deployment of the Party Central Committee and the State Council. The administration took the transparency of information as a breakthrough, expanded the range and increased the frequency of food and drug tests and sample inspections, cracked down the crimes in the field of food and drug, publicly released the information about the testing and investigation results and punishment in a timely manner, so as to protect consumers' interests and rights, thwart potential wrongdoers, regulate the supervisors' behavior, play up the supervisory role of public opinion and promote the construction of a social credit system.

We actively pushed ahead the institutional reform of the drug evaluation and approval system. We enhanced the approval standards, and conducted a technical evaluation of the new generic drugs applying to enter the market, as well as the ones that have already been sold, according to the quality and curative effects of the originals. We streamlined the administration system, improved the efficiency and piloted the reform of the holder of new drug marketing certificates, so as to boost China's transformation from a large drug producer to a strong power in the industry.

China is in a development stage where food and drug safety cases frequently occur. There is still a long way to go in guaranteeing food and drug safety. This year, we will strengthen the routine testing of food samples as well as their retailers, producers and restaurants at both the city and county levels, as it has been required by the Party and the State Council. We generalized the two tasks into two responsibilities.

We should deal with the excess residue of pesticides and animal medicine, and the excessive use of additives, as well as the other unlawful acts. We will make new standards, improve the law and rules, and draft more directive technological principles, and perform other fundamental work, to promote and regulate the research and development of the food and drug industries. We will deal heavy blows to the illegal acts threatening food and drug safety. We will continue to disclose information of the testing results, case investigation and punishment. We should improve the transparency of food and drug supervision, and strengthen the people's confidence with the food items and drugs made in China. We will establish a unified and authoritative food and drug administration system and institution, and form a professional, efficient, clean and responsible team of supervisors.

Powerful supervision makes powerful industries. The food and drug enterprises are not only supervisory targets but also service targets of the food and drug watchdog departments. The supervisors of various levels should put their supervision into services, spur innovation and development through effective supervision and innovative services, push ahead the supply-side structural reform of the food and drug industries, and consolidate the industries' foundation.

Food and drug safety directly concerns the people's livelihood, and are social issues as well. We hope people from all walks of life can actively take part in food and drug supervision, and promote social governance in the fields of both food and drug safety. Society should work together with the food and drug supervisory department to protect the people's "tongue tip safety." That's all for my introduction.

Guo Weimin:

Director Bi's introduction has been brief and to the point, leaving time for interaction with the media. Now, we'll open the floor for questions.

China Central Television:

As the director of the food safety office with the State Council and head of the China Food and Drug Administration, what is your perspective concerning the current food safety situation in China? What has the administration done in this field in 2015?

Bi Jingquan:

As for food safety, I would like to mention two things. Firstly, we should have confidence with China's food safety. Secondly, we need to continue to work hard. There are reasons in several fields justifying our confidence. First of all, sample testing has been increasing in recent years, and the results have steadily improved. Last year, the administration conducted sample testing on 170,000 batches of food, up 21 percent from the previous year and twice that of 2013. 96.8 percent of the food batches tested met a quality standard, 2.1 percentage points higher than that of 2014.

Second, in terms of supervision, we disclosed 6,552 batches of unqualified food to the public last year. The food and drug administration departments investigated 240,000 cases, among which 15,000 were criminal cases threatening public food safety investigated by public security forces. Last year, the food and drug administration issued 157 new food safety standards together with the public health administration. About 400,000 restaurants opened their kitchens for public supervision nationwide.

Third, in terms of legislature, the National People's Congress revised the Food Safety Law, which was implemented from Oct 1, 2015. The food and drug administration has made, and is making, a series of supporting rules to ensure the law to be enforced properly. The new law is a solid legal foundation for China to form the strictest supervisory institutions.

Fourth, in terms of the supervision system, the Party committee and governments at all levels have attentively implemented the decision to perfect the unified food and drug supervision system by the Party's central committee and the State Council. Across the country, 30 provinces, autonomous regions and municipalities, as well as 70 percent of cities and 30 percent of counties, have unified the food and drug supervision department, and established independent supervision agencies for the food and drug industry. This has also provided major institutional guarantees for the supervision of the food and drug industry.

The other thing I'd like to emphasize is that we still need to work hard. On one hand, food safety remains a big challenge. China is experiencing a period of development where food safety cases happen frequently. This has been decided by China's historical development stage. Large amounts of agricultural inputs have been used. The residue of pesticide and animal medicine constitute a big threat to food safety.

More than 11.8 million licensed food retailers and production enterprises are the main targets in our supervisory net. There are a large number of small, unlicensed workshops, vendors and eateries existing outside the borders of our supervision. Adulterate and counterfeit cases occur frequently. Three percent of foods sampled were still unqualified to enter the market. They would have been sold in the market and made available for consumers were it not for our investigation.

On the other hand, although the food safety in China is improving, it is still far from people's expectations and the requirements of the State Council. There are still some loopholes in our food safety standards. The punishments for law breakers remain ineffective, failing to serve as a deterrent to potential wrongdoers. Our supervision powers are still weak, the number of supervisors is still insufficient, the supervisory ability is not strong enough and part of the testing equipment is outdated. About 70 percent of counties and 30 percent of cities in China have not yet completed the food and drug supervisory institutional reform.

So, the food and drug administration still faces a lot of challenges regarding supervision. However, we are confident and have resolved to do the job well and defend the people's "tongue tip safety." As it has been stipulated by Party Chief Xi Jinping, "the strictest standards, the harshest supervision, the heaviest punishment and the most serious accountability" must be the benchmark.

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.