Health News:
Mr. Bi, the China Food and Drug administration recently suspended a digital code for drug supervision, is thatindicating the Administration to give up the trend of digital supervision or are you simply replace the old one with a brand new one? How will the Administration to respond to the associated request proposed by relevant enterprisesto cancel all digital supervision codes? Thank you.
Bi Jingquan:
The digital supervision code was created during our supervision work. It is very unlikely to carry on with no different voices or disputes.
First, the duties of the Administration are to uphold public health and ensure pharmaceutical safety and effectiveness. As a result, the application of modern technology reflects a liberal mind set and proactive action in a bid to better implement our tasks. As a supervision administration, we should be neither absent from our duties nor intervene in issues outsideour responsibility. A lack of duty and responsibility is dereliction and non-performance, whereas intervention is a misuse and abuse of power.
Second, entrepreneurs are majorly profit-driven. However, when they are pursuing their economic interests, they create wealth, job opportunities and taxes for society. Therefore, we should not be allegedly skeptical to the social responsibilities of entrepreneurs who may also be willing to make contributions to social development.
Third, when referring to the digital code, I had once responded to the issue at the supervision program launched to guarantee festival food safety in Guangdong on Feb. 3. I made a remark at a meeting involving entrepreneurs and healthcare staff. The enterprises are manufacturing entities, responsible for the research and development of food and drug, owning major responsibilities to the quality and safety of their products. Therefore, they should have a system capable of tracing back the trails of every single manufacturing process. The design of any policy should consider economic factors, effectiveness, fairness and legitimacy as well as a diversity of voices from every social sector , winning the understanding, coordination and support from entities under supervision. The remark is the result of our review and grasp of the disputes for the launch of the digital platform for administrative supervision. We'll follow the principles to further tackle the public consultation on the use of medicines, find out the real interests of enterprises and fully implement the Administration's duties. The problem left behind remains an actual problem influencing the future of the sector with great importance.
China Radio International:
In July of last year, the CFDA launched the self-examination of the clinical trial data for drugs. I would like to ask Mr. Bi about the work in this regard. Did you find any false data, and how did you deal with it? Thank you.
Bi Jingquan:
The clinical trial data of drugs is an important basis for drug evaluation. The prerequisite for medicine is its effectiveness, and the bottom line is its safety. In the past, we have stressed drug safety more and effectiveness less. But if a medicine is ineffective, then does it need to exist? The examination of clinical data is to check a medicine's effectiveness and safety, to see whether clinical data could substantiate the conclusion. The CFDA issued a memo last year on July 22, and listed all the 1,622 new medicines pending CFDA approval to enter the market, asking their manufacturers to conduct self-examination. In that batch, 193 drugs were exempted from self-examination and 1,429 drugs actually underwent the "self-exam."
As of Feb. 22, 2016, pharmaceutical companies voluntarily withdrew 1,136 drugs, accounting for 79 percent of all medicine in this round of self-examination. A total of 1,184 drugs were either withdrawn from the self-exam or failed it, accounting for 83 percent of the total number. We publicized the cases with inauthentic or incomplete clinical data in two batches and decided to disallow 24 drugs to enter the market.
As for the results of the third round of self-exams, the CFDA is still communicating with the manufacturers and will publicize the results soon. On Feb. 27, we announced another case that involved false data of clinical medical equipment. Cracking down on infringement and counterfeiting, and protecting property rights is the requirement of the CPC Central Committee and the State Council. Producing and selling counterfeit goods is strictly prohibited by the Criminal Law, Food Safety Law, Drug Administration Law and others; these actions are violations of the law and crimes.
We required applicants to launch self-examinations regarding their clinical data, and withdraw applications that had validity problems or failed to be complete, in a bid to warn these manufacturers of legal risks, so that they will develop high-quality and effective medicine for our family members, relatives and friends, and our future generations. It is a matter of legal issues as well as one of moral, conscience and social responsibility.
Therefore, I am taking this opportunity to remind all manufacturers of food, medicine, medical equipment and health food, as well as the retailers of food and drugs, legal representatives, principal managers and quality controllers of catering businesses that you should strictly abide by law in your production and sales processes, strictly follow quality-control regulations, ensure that your data is valid, complete and accurate, and prohibit any false records, counterfeiting, false advertising or any other illegal activities.
Those involved in the food and drug industry should be law-abiding role models. They should have high morals, and be responsible for people's health. Such requirements help to protect the safety of the public, and the safety of businesses engaging in food, drug and medical equipment, along with their personnel. Anyone that jeopardizes public safety will be caught. The verdict of the OSI Group in Shanghai on Feb. 1, hopefully, will be a lesson for all. I wish you to convey my words to the public. Thank you!
