"Promoting the listing of erlotinib in China?" All of the people present were among the best in the domestic biological circle, and when they heard Li Zheng's words, 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 China can follow suit. "
Changing China's new drug approval system and speeding up the connection between China's drug market and the international market is one of the most important reasons why Li Zheng gave up the excellent experimental environment in Hong Kong and returned to China.
And erlotinib will become the starting point for him to leverage the stubborn stone of new drug approval.
In Li Zheng's last life, Huaguo's new drug approval system seemed to have become a great shackle to the development of Huaguo's biopharmaceuticals. For example, when the CFDA was still the SFDA, the Drug Registration Department, as the key department of the SFDA, held great power.
Huaguo SFDA does not require clinical trials for new drug registration of drugs already on the pharmacopoeia, and 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 transformation of scientific research results into productivity as soon as possible.
However, is this really the case
Li Zheng has seen a data that in 2004, the SFDA in Huaguo accepted 10,009 new drug applications for approval, while the US FDA accepted 148 new drug applications for approval in the same period. The huge data discrepancy made Huaguo biopharmaceutical industry a joke for a while.
Among the so-called new drugs submitted for approval, there are no more than 20 first-class new drugs approved in China, and the rest are all generic drugs. The drug that has been changed into a so-called new drug has become a so-called new drug, and it has been in the market in front of the Chinese people. And many pharmaceutical research institutes.
They do not have much research strength themselves, and their daily work is to find information, make declarations, get approval documents, and then use the state's preferential policies for new drugs to make huge profits.
This market phenomenon greatly undermines the ecology of the domestic new drug research and development market and discourages researchers. At the same time, it makes the real new drugs mixed with such overused drugs and cannot be released for a long time.
Drawing on blank paper is much simpler than drawing on paper that has been painted in a mess. The current Huaguo new drug approval process has not yet been fully solidified. Putting it on drug research and development, for them, completing the research and development is equivalent to completing the task.
"This... You can apply to the relevant department, it shouldn't be difficult to get approved." Tian Lao said naturally.
He has seen Li Zheng's clinical data, which is very detailed. In his opinion, this should not be a big problem.
"It's really not a big problem. Two days ago, I had already received the rule that the drug entered the approval process."
Everyone was stunned for a moment, and then they reacted. With Li Zheng's current reputation, it's not surprising that such a thing happened.
"Isn't this very good, I have seen your clinical data, it is very detailed, and there is no problem. Life-saving medicine needs to be handled specially!" Tian Lao was full of optimism.
On the contrary, Old Yang, who has always shown an impulsive image, frowned and never let go.
"Li Zheng, have you asked anyone to say hello?" Elder Yang said suddenly.
Li Zheng raised his eyebrows, but didn't hide it, "Yes, when I submitted the new drug for approval, I asked someone to help clear it up."
When everyone heard the words, there was a bit of a tangled look on their faces, but in the end, most of the people's opinions were just as Tian Lao said just now.
As a result, everyone's concept of the drug approval system is evident.
This is the top group of people in the current Huaguo biological circle.
Li Zheng didn't go around with them, "Seniors, don't you think there's something wrong? Watson, Berger, and Gilbert are all Nobel Prize winners and world-class top biologists. Guarantee, the accelerated approval time given by the FDA is 1-3 years. In these three years, what the FDA has to do is the clinical approval of drugs.”
"In our country, we don't even have a standard for clinical approval. In the long run, this is not a good phenomenon for biopharmaceutical people." Li Zheng, who was twenty-one years old, had a solemn look on his face. .
Drug approval? Zhao Depei's expression is a little subtle, and this is not just a matter of science. However, he had to admit that what Li Zheng said did make sense.
Compared with the older generation of biological people who are immersed in the laboratory, Zhao Depei is the principal of Huaqing, and he still has some contact with the officialdom. In the current drug registration department, there are only dozens of personnel engaged in the approval of first-line drugs, and the highest degree is only Universities, requiring clinical medicine or something, are too embarrassing for them.
However, Li Zheng is right. In order to truly standardize the domestic drug market and integrate with the international market, it is essential to establish a sound clinical trial standard.
Only perfect clinical trial specifications 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, if it makes sense, it makes sense, but after all, this is not just a matter at the scientific level, it is not easy to do.
Everyone present also heard Li Zheng's implication, "Why, Li Zheng, are you interested in the approval of new drugs?" Yang Lao smiled. Yang Lao himself is one of the members of the State Drug Administration. One of the highest approvers of Huaguo's new drugs into the market.
Regarding Huaguo's drug approval system, he had some vague concepts and ideas in his mind, but they never materialized. Li Zheng's words were like a slap in the face, which made him a lot clearer at once.
But as a biologist, he has always positioned himself as a scientist. He doesn't care too much about such trivial matters as the system, approval, and so on. From this old senior's point of view, this is not doing a proper job!
"Li Zheng, you are a natural scientist, don't let other things distract you." Yang Lao said earnestly.
The arrogance and pride of the older generation of scientists is also an important reason why the approval of drugs in Huaguo is controlled by a group of laymen, and the clinical standards for drugs have not been established.
"Old Yang, what is the meaning 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, glanced at the group of old scientists who had devoted their lives to biological science, and said word by word: "I am different, the purpose of my research in biology is very simple, transform it into productivity, convert My projects are transformed into visible productivity.”
Li Zheng's remarks are as if in ancient times when everything was inferior and only high in reading, there was a scholar who shouted out that I was studying for the purpose of promotion and making a fortune.
Li Zheng didn't mean to stop. In his mind, the scene when he first went to Huaqing to meet Chen Angang in his previous life appeared. At that time, Chen Angang was in his fifties, and his long laboratory career made him look more than The peers are even thinner.
However, Li Zheng would never forget his powerful 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 senior, and because of his words, I I gave up molecular biology, which I was good at, and devoted myself to biopharmaceuticals." This was the first time Li Zheng took the initiative to mention his original matter.
This caused all the seniors in the Huaguo biological circle to look at each other in dismay. The senior Li Zheng said should be from their generation. How could any of them have such a great influence on this genius biologist
"Drugs are not works of art, they are for people's appreciation. Only when drugs are used on people and can really cure diseases and save people can they live up to the days and nights in our research laboratory. The sooner a real good drug is released, the sooner it will be released. It is imperative to save an extra 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 about the Human Genome Project, but Li Zheng threw a blockbuster on everyone at the beginning of the meeting.
Reforming the drug approval system is hard to say, but easy to say.
Because everyone present is the most influential group of people in the biological circle of China, and their peaches and plums are all over the world, and many of them are officials with real power in the health department.
Even several of them, like Mr. Yang, have people from the State Drug Administration on their heads. Many of them don't care much about this title, but if they are really used, it can change the status quo of drug approval in China. .
The State Drug Administration, the highest authority of the drug regulatory department directly under the State Council, has 24 standing members. Every major decision on a drug must be voted on by 12 members present, with more than half of the votes passed.
The members of the committee are selected by election, and the officials of the relevant departments such as the Ministry of Health and biologists are divided into half and half. It's just that the 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 members have hardly attended the committee. In other words, officials from the Ministry of Health and other relevant departments have voted on major issues such as drug approval and drug listing in China.
"Li Zheng, you mean to change the status quo of drug approval in Huaguo?" Someone asked.
"No, this goal is too broad. The first step I need to do now is to establish a relatively complete clinical standard for drugs."