Rebirth of the God-level Xueba

Dai Zhi came to the office with a relaxed gait, locked the artificial leather briefcase in the drawer, and went out to have breakfast.

The permanent staff of the GMP committee are the six staff members in the standing committee office. Because the number is too small, they discussed with the Maternal and Child Health Hospital next door to share a canteen.

The Maternal and Child Health Hospital is naturally very happy, after all, everyone likes to have free things delivered.

Dai Zhi also likes to eat with the girls and daughters-in-law of the Maternal and Child Health Care Hospital. Although he can't do anything, he just chats and takes a look, and he always feels happier. What's more, the things sent by major pharmaceutical companies don't need to cost him money.

"Master Li, I want tofu nao, fried dough sticks, and a bowl of soy milk, and some side dishes." Dai Zhi walked into the cafeteria of the Maternal and Child Health Care Hospital through the side door, and greeted the people inside with ease.

When Master Li saw that it was Dai Zhi, he immediately wiped his oily hands on his apron, and said with a smile, "Director Dai is here, I'll scoop up his tofu brain, tofu brain, you don't have to dig a spoon, you have to slice it , do you know? Scooping tofu nao is neither thin nor thick, but rich in flavor..."

He chatted mysteriously about his tofu brain sutra, then brought it to Dai Zhi, and said with a smile: "I like diners like you, Director Dai the most. You know what to do and how to eat. Good things are for you to eat, so don't waste them."

Dai Zhi sniffed his nose with a smile, took a mouthful of tofu nao with a spoon, nodded, and said, "Water from Yuquan Mountain?"

"Excellent." Master Li wore an apron in one hand, raised the other hand, shook it three times, and said, "Representative Feng from Jingxi Pharmaceutical General Factory brought it over, and put it at the door of our cafeteria at five o'clock in the morning."

Dai Zhi nodded: "Jingxi Pharmaceutical General Factory built a sanatorium in Yuquan Mountain, and they can get water conveniently."

Seeing that Dai Zhi didn't care about details like five o'clock in the morning, Master Li scolded in his heart, "Officials don't treat people as human beings", and said with a smile on his face: "That's right, they get up earlier and start to work." It’s not too much trouble to get a car here.”

Dai Zhi glanced at Master Li and nodded calmly, as if what he was talking about just now was something like tofu brain.

It's not news that the representatives of the pharmaceutical factory tried different ways to please the committee members and the staff in the committee's office. At the beginning, Dai Zhi was a little uncomfortable, but now he is used to it.

After all, they have too many things that affect the lifeline of the pharmaceutical factory. It is nothing if the representative of the pharmaceutical factory wakes up at two o'clock in the morning to pick up and deliver water.

Dai Zhi thought to himself: If I were the director of a pharmaceutical factory, as long as everything went well, it would be fine to hire someone to deliver water.

He ate his breakfast with peace of mind, and ordered another soft-boiled egg back to the office, preparing to eat it when he was hungry at noon.

He pays more attention to health preservation now, at noon and evening, if there is no meal, he eats very little.

Of course, there is very little time without dinner.

When Director Dai slowly returned to the office, there were already representatives of the pharmaceutical factory who got up early in the corridor.

Most of these people came to ask about the progress and the "response letter". With the reply letter from the GMP committee, the subordinate departments of the Ministry of Health will review the application for market entry-that is another long process. However, compared with their foreign counterparts, these pharmaceutical factories that are still affiliated with state-owned enterprises are still happy.

"Director Dai."

"Director Dai!"

"Good morning, Director Dai."

The representatives greeted Dai Zhi one after another, and he also smiled slightly, like a leader inspecting work, opened the door and walked into the office.

"director!"

"The director is back."

In the office, all the staff stood up and said hello to Dai Zhi.

Dai Zhi waved his hands, and his eyes fell on the back in front of his desk.

Standing in front of the partition was none other than Feng Manrong from Jingxi Pharmaceutical General Factory.

Dai Zhi said in his heart: "This representative Feng looks a little nice from the back."

He stood still and watched for two seconds, then coughed and said, "Representative Feng? Is there something wrong?"

"Director..." Feng Manrong's voice sounded a bit like a Hong Kong and Taiwan drama, with a hint of coquettishness, but if you think about it carefully, it doesn't seem to be there.

Dai Zhi is fifty years old, and he likes this trick the most. He narrowed his eyes and said, "Xiao Feng...what's the matter?"

"Director, the letter of application and reply sent by our factory has not yet come out. The director of the factory held a meeting yesterday and scolded me bloody. If you don't help me, I... I can't do anything It's gone." Feng Manrong has completely entered the coquettish mode, and by the standards of 1985, she is already disgusting.

Dai Zhi smiled involuntarily, waved his hands, and said, "Come in and sit down, I'll look for it for you, which reply letter?"

"It's the drug 'Lubodin'. It has been used in Germany and the United States for several years, and our factory manager wants to come to the agency right now. It's agreed to be launched this year." Feng Manrong didn't say much here, Sitting across from Dai Zhi's desk, he took an empty teacup, grabbed the tea leaves and poured water, all in one go. This is the advantage of a female salesman. Dai Zhi squinted his eyes and saw it, and didn't think there was anything wrong with it. Now that he was a male salesman, he was already facing the end of being beaten or thrown out.

Dai Zhi nodded, and said, "I'll know if you say Lu Bo is set. That letter should be for Committee Member Yang."

"I went to his office to look for it several times, but I couldn't find it. I really had no choice, so I came to you."

"Commissioner Yang must be on a business trip." Dai Zhi still didn't call him by his first name. This is the rule he set for himself, so as not to offend others when he gets used to it in private. He is not familiar with Yang Rui's personality, but in his mind, Yang Rui, who is only 20 years old and famous, must be very sensitive to his identity. One word more than Yang Rui, I can't die of exhaustion.

With a smile on her face, Feng Manrong followed Dai Zhi and called out: "I heard from Committee Member Yang's subordinates that he seems to have gone back to his hometown to supervise the project of Huarui Pharmaceutical Factory. It will take half a month, and it seems that he won't be back for a while. not coming."

Dai Zhi tasted it all at once, and said with a smile: "The deadline for the reply letter is here, isn't it?"

Feng Manrong smiled and said nothing.

The GMP committee came with reference to the Western model - now there is nothing to learn if you don't learn from the West. The Soviet Union has begun to learn from the West. Naturally, China can only follow the existing Western things.

According to the Western model, when a pharmaceutical company submits a drug marketing application, the FDA or other abbreviated Drug Administration must give a reply within a limited time, and the reply document is called a reply letter.

Response letter is a proper term. In the West, the Drug Administration has the right to reply freely and undertakes the obligation to reply within a time limit.

And pharmaceutical companies have the right to make public or not, or even part of the reply letter. In short, if the content of the reply letter is beneficial to the pharmaceutical company, or part of it is beneficial to the pharmaceutical company, the pharmaceutical company can disclose all or part of it, and if the content of the reply letter is not conducive to the pharmaceutical company, Pharmaceutical companies can then not disclose, or still partially disclose.

Moreover, pharmaceutical companies do not need to follow the requirements in the reply letter. The requirements in the reply letter are not mandatory. Some pharmaceutical companies feel that the U.S. Drug Administration’s reply letter is not friendly, so they can pretend that nothing happened. Go to the UK and apply for listing, or reverse the process.

The domestic system that has been copied in a hurry will naturally not deliberately modify the time limit for the reply letter.

In fact, foreign drug administrations have a series of complex flows, and often feel that time is not enough, and there is no such problem in China.

Dai Zhi didn't take it seriously, waved his hands, and said, "Xiao Wang, you can go and find the reply letter from Jingxi Pharmaceutical General Factory, Lu Boding!"

"Okay." Xiao Wang put down what he was doing, and immediately went through a pile of letters.

After a while, Xiao Wang brought over three similar-looking file bags.

"Why didn't you hand it over to the factory in advance?" Dai Zhi pretended to criticize.

Xiao Wang explained in a low voice: "Commissioner Yang's letter was only delivered today, and we just opened it."

"Okay, you can go." Dai Zhi turned his head and said to Feng Manrong: "There is no way, the committee members are very busy. Please understand."

"Understood." What Feng Manrong could say, she wanted to get the reply letter now, and hand it over to her colleagues in the Ministry of Health for the next step. "

Dai Zhi is an old organization, and he was not in a hurry to hand over the things to Feng Manrong, but took out the three file bags one by one.

"This letter is from Commissioner Fan Yuanwei." Dai Zhi picked up the top document and looked at it, then seemed to check the signature carefully, put it aside, and said with a smile: "Yes, it is approved."

"Thank you very much."

"This letter is from Commissioner Song Hongxi...Well, it is approved."

"Thank you very much."

"This is from Committee member Yang Rui...well, it's not approved?" Dai Zhi couldn't help but widen his eyes.

"Many..." Feng Man Rong's voice froze.

She hurriedly looked up at Dai Zhi, and found that his expression was not joking, she couldn't help being startled, and asked, "What's the reason?"

"The scope of animal toxicity tests is too small, and the safety of clinical trials is doubtful. It is recommended to supplement safety clinical trials." Dai Zhi read it word by word.

"And then?" Feng Manrong asked.

"No, that's all." Dai Zhi replied.

"Just that one sentence?" Feng Manrong asked anxiously, "What does he mean by that?"

Dai Zhi's expression turned into poker, and he said, "Committee Yang has made it very clear that he will not pass the test. Please supplement the test."

"Didn't two committee members pass it? Two votes to one vote, it should pass."

"The rule of the GMP committee is a one-vote veto system, not a minority obeying the majority."

Feng Manrong's head went hot, and she forgot all the training she had received before. She said angrily, "It's easy for him to veto it with one vote. In one sentence, our whole factory has been working in vain for several months? Now the raw materials are all gone." When we are ready, we wait for the approval of production, and the people who run our factory have lost a lot of weight..."

Dai Zhi interrupted Feng Manrong, said with a straight face, "Representative Feng, this is Committee Yang's decision, and our office cannot interfere. I suggest that you go back to the factory to discuss it."

"Director Dai..."

"I can't do anything." Dai Zhi shook his head.

The staff behind were also stunned when they heard it. Fortunately, they all had good eyesight. No one dared to watch the show, so they dragged Feng Manrong out first.

"From now on, without my permission, representatives of the pharmaceutical factory are not allowed to enter the office." Dai Zhi waited for the door to close and announced new discipline.

The staff sat back to their seats silently, expressing their shock with their eyes and expressions.

Since the establishment of the GMP Committee, this is the first reply letter of "Not Approved".

It is conceivable that Jingxi Pharmaceutical General Factory, which has already invested a huge amount of money, will not let it go.

...