China Pharmaceutical News:
Mr. Bi, the shortage of child-friendly medicine is a general concern for parents and society as a whole. What kind of encouraging policies does the Food and Drug Administration (CFDA) have to research and develop child-friendly medicine, so as to meet consumer needs?
Bi Jingquan:
We have noticed a few related reports. Currently, approved medicine can basically meet the needs for common pediatric diseases. The prominent problem is mainly with regard to the shortage of a child-friendly dosage and standard. For those medicines which are absent in the domestic market but badly needed in clinical, the CFDA has set up special access for declaration and examination to speed up the process. On Jan. 29, the CFDA released an announcement to detail related polices on clinical pediatric medicine.
Therefore, the problem is not about batch number, but about economic benefits for enterprises. To solve the problem, ask for joint efforts from both the CFDA and from other departments.
People's Daily:
I noticed that EU countries encourage the use of generic drugs and have related policies. I noticed that the Food and Drug Administration (CFDA) is asking enterprises to carry out conformance assessments of the efficacy of generic drugs. I would like to ask, why is the CFDA carrying out the assessment? What kind of encouraging polices do we have? Thank you.
Bi Jingquan:
To carry out the conformance assessment of the quality and efficacy of an approved generic drug is to make up for missed lessons. Since we didn't have these kinds of mandatory requirements in the past to carry out conformance assessment between generic drugs and the original formulation, some generic drugs are different from the original formulation regarding efficacy, especially those drugs produced before 2007. The U.S. and Japan have also experienced the same process with that issue; it took Japan over 10 years to promote this kind of work. To carry out the conformance assessment is to guarantee the generic drug and original formulation share the same quality and efficacy, so they can replace each other and save on social medical expenses. On Feb. 20, the State Council formally issued several opinions on promoting the conformance assessment of generic drugs, including the following content.
Firstly, the subjects of conformance assessments are enterprises. Enterprises should take the initiative to find reference products, and research and carry out clinical trials based on the prescribed method.
Secondly, the government should coordinate the confirmation, evaluation methods, data reporting and evaluation of the reference product, and guide the entire process.
Thirdly, policy support should be provided regarding clinical use and medical insurance.
Fourthly, we have defined the schedule. From now until the end of 2018, we will finish the conformance assessment of the oral solid dosage form of generic drugs included in national essential drug lists and approved before Oct. 1, 2007. By then, the generic drugs which couldn't be approved by the assessment will lose their drug approval number. For those generic drugs that have already come to market, the same variety of generics produced by other manufacturers have to pass the quality consistency evaluation within three years after the originator's products passed the same evaluation, otherwise, their approval number will be revoked. This is a huge challenge for all enterprises. However, it also a crucial task for our country to improve our medicine quality, transform from pharmaceutical giants to a great power, and introduce Chinese made pharmaceutical preparations to the international market.
For enterprises, there is not only pressure but also hope.
Procuratorial Daily:
Through media reports, it is not difficult for us to find the illegal and criminal acts in the food and drug field where such acts now occur frequently. One of the reasons is the related departments' lack of supervision and their administrative inaction. The specific performances include the acts of replacing criminal penalties with fines and not transferring cases to higher courts for ruling. I would like to ask Mr. Bi, in the past year, what efforts have been made by the China Food and Drug Administration to promote the link between administrative law enforcement and criminal justice? What breakthrough achievements have been made in this regard? Thank you.
Bi Jingquan:
The phenomenon that food and drug supervision departments are blamed for weak law enforcement or administrative inaction is a reality. However, generally speaking, food and drug supervision departments have kept forging ahead in the past few years, strengthening food and drug inspection efforts, strengthening spot checks on food and drug production enterprises, and making the results of spot checks known to the public without delay. Comparatively, good effects have still been produced. At the same time, the problems mentioned by the reporter indeed exist, such as replacing criminal penalties with fines, turning big problems into small problems and small problems into nothing. Moreover, they have a direct relationship with the current judicial system which is dominated by administrative penalties, and also have a close relationship with local protection and various interferences in the process of handling cases.
During the work, we have established a good cooperative mechanism with the Ministry of Public Security to conduct cooperation in sharing information, transferring cases to higher courts for ruling and publicizing the results of punishments. Many of the cases cracked by the public security departments were based on the clues provided by the food and drug supervision departments. Recently, the China Food and Drug Administration, the Ministry of Public Security, the Supreme People's Court and the Supreme People's Procuratorate jointly issued a work suggestion on strengthening the link between administrative law enforcement and criminal justice, which has made clear provisions on the standards of collecting evidence, transferring cases to higher courts for ruling, exchanging information and strengthening cooperation. While handling these issues, we need to cooperate closely and more importantly increase criminal punishments for illegal acts and criminal acts in the food and drug industry. The effect of punishments can be greatly reduced if responsibilities are not held to the person concerned. Just now, you mentioned the crime committed by the Shanghai Husi Food Co. Ltd. on food safety. Actually, the company was charged with manufacturing and selling counterfeit products. A powerful deterrent cannot be produced regarding food-and drug-related crimes until acts such as adulterating foods, manufacturing counterfeit products and OEM processing are all included into crimes. I don't think the food and drug supervision departments are greedy for this kind of administrative punishment power. Actually, we are working hard to fulfill our duties and achieve our goals of safeguarding and promoting public health. Personally speaking, and from the perspective of the head of the China Food and Drug Administration, I hope all the acts of adulterating foods and selling counterfeit products will be directly declared guilty, investigated their criminal liabilities and attached the corresponding administrative punishments to these crimes at the same time. As the food and drug supervision department, we must work towards this direction to promote this work. Thank you.
Finally, I would like to express my heartfelt thanks to the reporters from various media outlets who attended today's press conference. Thank you for your concern, stress and support of our food and drug supervision work. I also hope that in the future you can follow, with great interest, the website of the China Food and Drug Administration. Our website is now the most authoritative platform for releasing food and drug supervision information. It is also the most timely platform in this regard. If you want to get any breaking news, just keep a close eye to our website. Thank you.
Guo Weimin:
Thanks to Mr. Bi and all the reporters. We hope you will do a great job in reporting the press conference. Doing a good job in ensuring food and drug safety is also the desire of society as a whole. Thank you.
