Chapter 180:

"Promote the listing of erlotinib in China?" All the figures present were among the best in the domestic biological circle. Hearing what Li Zheng said, they couldn't help but look at each other.
"Yes, erlotinib, as the first anti-cancer targeted drug, is of great significance to the history of human drugs and the market. The FDA has made it clear that it will speed up the drug approval process, and I hope that the country will follow suit. "
Changing China's new drug approval system and speeding up the connection between China's drug market and the international market is also one of the most important reasons for Li Zheng to abandon the excellent experimental environment of Xiangjiang and return to China.
And erlotinib will become the basis for him to pry the new drug approval stone.
When Li Zheng's last reign, the new drug approval system in China has become a great fetter for the development of China's biopharmaceuticals. For example, when CFDA was still SFDA, the Department of Drug Registration, as a key department of the SFDA, was very powerful.
The Chinese SFDA does not require clinical trials for new drug registration for drugs that have been listed in the pharmacopoeia. The approval time is generally between 1 year and 18 months, while the US FDA's approval time for real new drugs may last 6-8 years.
In this way, it seems that China's new drug approval system has greatly promoted the research and development of new drugs, which is conducive to the rapid transformation of scientific research results into productivity.
However, is this really the case?
Li Zheng looked at a piece of data. In 2004, the China SFDA accepted 10009 new drug approvals, while the US FDA accepted 148 new drug approvals during the same period. The huge difference in data made the Chinese biopharmaceutical industry a joke for a while.
Among the so-called new drugs approved for approval, no more than 20 new drugs of the first category have been approved in China, and the rest are all generic drugs. Once the modified drugs have changed, they have become so-called new drugs, which have been swayed by the Chinese people. And many pharmaceutical research institutes are born.
They don't have much research strength themselves, and their daily work is to find information, apply for declarations, obtain approval documents, and then use the country's preferential policies for new drugs to make huge profits.
This market phenomenon has greatly damaged the ecology of the domestic new drug research and development market and discouraged the enthusiasm of researchers. At the same time, real new drugs have been mixed with such overfilled drugs and have not been available for a long time.
Drawing on blank paper is far simpler than drawing on paper that has been painted in a mess. The current Huaguo new drug approval process has not yet been fully cured. Most of the Huaguo biological people immersed themselves in the laboratory and looked at Putting it on drug development, for them, completing the development is equivalent to completing the task.
"This...you can apply to the relevant department. It shouldn't be difficult to approve it." Tian Lao said naturally.
He has seen Li Zheng's clinical data, which are very detailed. In his opinion, this problem should not be a big deal.
"The problem is really not big. Two days ago, I had received the rule of the drug entry approval process."
Everyone was stunned for a moment, and then reacted. With Li Zheng's current reputation, it is really not surprising that something like this happened.
"Isn't this very good? I have seen your clinical data. They are very detailed and there is no problem. The life-saving medicine must be handled specially!" Tian Lao is full of optimistic thoughts.
It is Yang Lao, who has always shown people impulsively, his brows have never loosened.
"Li Zheng, did you say hello?" Old Yang suddenly said.
Li Zheng raised his eyebrows without covering up, "Yes, when I submitted the new drug for approval, I asked someone to help dredge it."
When everyone heard the words, their faces were a little tangled, but in the end, most people's opinions were just like what Tian Lao said, life-saving medicine, special affairs, and special affairs are not considered to be a major violation of the rules.
From this, everyone's concept of the drug approval system can be seen.
This is the top group of figures in the current Chinese biological circle.
Li Zheng also didn’t go around with them, "Predecessors, don’t you think there is something wrong? Watson, Berg, and Gilbert are all Nobel Prize winners, world-class biologists, and three of them work. Guarantee, the accelerated approval time given by the FDA is 1-3 years. In these three years, what the FDA has to do is clinical approval of drugs."
"And our country of China does not even have clinical approval standards. From a long-term perspective, this is not a good phenomenon for biopharmaceuticals." Li Zheng, who is 21 years old, has a solemn expression on his face. .
Drug approval? Zhao Depei's expression is a bit subtle, this is not just a matter of science. But he has to admit that what Li Zheng said is indeed reasonable.
Compared with these older generations of biological people who are immersed in the laboratory, Zhao Depei is the principal of Huaqing, and has some contact with the officialdom. The current Drug Registration Department has only a few dozen personnel engaged in first-line drug approval, and the highest degree is just University, it is too difficult for them to ask for clinical medicine or something.
However, Li Zheng is right. If the domestic drug market is to be truly regulated and to be in line with the international market, it is essential to establish a complete clinical trial specification.
Only perfect clinical trial standards can ensure the scientific nature of the drug access mechanism, promote the healthy and stable development of the domestic drug research and development market, and provide institutional guarantees for the smooth entry of foreign drugs into the Chinese market.
However, it makes sense, but it is not just a matter of science, it is not easy to do.
Everyone present also heard Li Zheng's implication, "Why, Li Zheng, are you interested in the new drug approval?" Old Yang smiled. Yang himself is a member of the National Drug Supervision and Administration Commission. One of the highest approvers of Huaguo's new drug market.
Regarding the drug approval system in China, he has some vague concepts and ideas in his mind, but they have not been concretized. Li Zheng's words are like enlightenment, which makes him clear a lot at once.
However, as a biologist, he has always positioned himself as a scientist. He doesn't care too much about the system, approval and other trivial matters. From the view of this senior, this is not doing his job properly!
"Li Zheng, you are a natural scientist, don't let other things distract you." Yang Laoyu said earnestly.
The lofty pride of the older generation of scientists is also an important reason why Huaguo's drug approval is controlled by a group of laymen, and drug clinical regulations have not been established.
"Lao Yang, what is the significance of our study of biology?" Li Zheng's eyes became a little serious.
Old Yang was obviously startled, "meaning, exploring the mysteries of life science."
Li Zheng smiled. He raised his head and glanced over a group of old scientists who had dedicated their lives to biological sciences. He spoke word by word: "I am not the same. My purpose in studying biology is very simple. Turn it into productivity. Each of my projects is transformed into visible productivity."
Li Zheng's statement was like in the ancient times when everything was inferior but only a high school, a scholar shouted out that I was studying for promotion and fortune.
Li Zheng didn't mean to stop. The scene in his mind when he first came to Huaqing to meet Chen An Gang in his previous life. Chen An Gang was already over 50 years old at that time. His long laboratory career made him look better. People of the same age are much thinner.
However, Li Zheng will never forget his utterly loud words.
"Exploring the mystery of life and pursuing the essence of life is a noble thing. But the current state of the country does not allow us to be noble. This is the original words of an old man, and because of his words, I Give up the molecular biology that he was good at and devote himself to biopharmaceuticals." This is the first time that Li Zheng took the initiative to bring up his original matter.
This made the elders in the Chinese biology circle look at each other. The elder in Li Zheng's mouth should be his generation, right? Some of them have such a big influence on this talented biologist?
"Drugs are not works of art, they are provided for people to appreciate. Only when drugs are used on humans and really play a role in curing diseases and saving people, can they live up to the day and night in our research room. Really good drugs will be on the market as soon as possible. It is imperative to save one more life, reform the drug approval system, and strengthen the drug transfer mechanism."
There was silence in the conference room. This meeting was initiated by Li Zheng. Everyone thought it would be a meeting on the Human Genome Project, but they didn't expect that as soon as the meeting started, Li Zheng dropped a blockbuster on everyone.
Reforming the drug approval system is difficult and easy to say.
Because all the people present are the most influential people in the Chinese biology community, their peaches and plums are all over the world, and many of them are officials in the health department.
Even several of them, like Mr. Yang, have people with the National Drug Supervision and Administration Commission. Many of them don't care about this title, but if they are really used, they can change the current status of drug approval in China. .
The National Drug Supervision and Administration Commission, the highest power opportunity of the drug regulatory department directly under the State Council, has 24 permanent members. Every major drug decision must be voted by twelve members and passed by more than half of the votes.
The members of the committee are selected by selection, and officials from the Ministry of Health and other relevant departments and biologists are divided into half and half and half. It's just that these old scholars in China have always been impatient with these mundane things.
Therefore, the committee has been established for so long, and these biologists with the title of committee have rarely attended the committee. In other words, officials from the Ministry of Health and other relevant departments voted on major matters such as the approval of drugs in China and the listing of drugs.
"Li Zheng, do you mean to change the status quo of drug approval in China?" someone asked.
"No, this goal is too broad. The first step I want to do now is to establish a relatively complete clinical specification for drugs."