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

The permanent staff of the GMP committee are the six staff members of the Standing Committee's office, and because the number is too small, they negotiate with the maternal and child health hospital next door to share a canteen.

Maternal and child health hospitals are naturally happy to come, after all, everyone likes to have free things to be delivered.

Dai Zhi also likes to eat with the eldest girls and little daughters-in-law in the maternal and child health hospital, although he can't do anything, but he just chats and takes a look, and he is always in a happier mood. Moreover, the things sent by major pharmaceutical companies do not cost him money.

"Master Li, I want a tofu brain, fried dough sticks, and a bowl of soy milk, and look at some side dishes. Dai Zhi walked into the canteen of the Maternal and Child Health Hospital through the side door and greeted the people inside.

When Master Li saw that it was Dai Zhi, he immediately wiped his oily hand on his apron, and said with a smile: "Director Dai is here, I'll scoop his tofu brain, tofu brain, it's not just a spoonful, you have to cut it, do you know? Scoop the tofu brain, it's not thin, it's not thick, it's ...... flavor."

He chatted about his tofu brain scripture in a mysterious way, and then brought it to Dai Zhi, and said with a smile: "I like diners like you the most, Director Dai, who know how to do and know how to eat, and you can eat good things without wasting them." ”

Dai Zhi sniffed with a smile, scooped a mouthful of tofu brain with a spoon, nodded, and said, "The water of Yuquan Mountain?"

"Awesome. Master Li held an apron with one hand, cocked the other, shook it three times, and said, "Representative Feng from Jingxi Pharmaceutical General Factory sent it over, and it was placed at the door of our canteen at five o'clock in the morning." ”

Dai Zhi nodded: "Jingxi Pharmaceutical General Factory has built a sanatorium in Yuquan Mountain, and it is convenient for them to get water. ”

Seeing that Dai Zhi didn't care about details such as five o'clock in the morning, Master Li scolded in his heart, "Officials don't treat people as people", and said with a smile on his face: "That's what I said, it's not particularly troublesome for them to get up early and drive a car." ”

Dai Zhi glanced at Master Li and nodded calmly, as if he was still talking about things like tofu brains just now.

It is not news that the representatives of the pharmaceutical companies are changing their ways to curry favor with the committee members and the staff of the committee members' offices, and Dai Zhi was a little uncomfortable at the beginning, but now he is used to it.

After all, they have too many things that affect the lifeblood of the pharmaceutical company, and the representatives of the pharmaceutical company get up at two o'clock in the morning to pick up water and deliver water, which is nothing.

Dai Zhi thought to himself: If I am the director of a pharmaceutical factory, as long as everything goes well, what if I hire someone to deliver water?

He ate his breakfast with peace of mind, and asked for a soft-boiled egg to go back to the office, ready to eat when he was hungry at noon.

He is now more health-conscious, and eats very little at noon and at night if there is no meal.

Of course, there is very little time without a meal.

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

With the reply letter from the GMP committee, the subordinate departments of the Ministry of Health will review the application for market entry - it is another long process, but compared with their foreign counterparts, these pharmaceutical companies that are still affiliated with state-owned enterprises are still happy.

"Director Dai. ”

"Director Dai!"

"Director Dai, morning. ”

The delegates greeted Dai Zhi one after another, and he also smiled slightly, like a leader of the inspection work, and pushed the door into the office.

"Director!"

"The director is back. ”

In the office, all the staff stood up and greeted Dai Zhi.

Dai Zhi waved his hand, and his eyes fell on the back of his desk.

Standing in front of the partition was Feng Manrong from Jingxi Pharmaceutical General Factory.

Dai Zhixin said: "This Feng representative looks at the back, and it is a little good-looking." ”

He stood and looked at it for two seconds, then coughed and said, "Representative Feng, is there something wrong?"

"Director......" Feng Manrong's voice has a little bit of the sound of Hong Kong and Taiwan TV dramas, and a little coquettishness, but if you think about it carefully, it doesn't seem to be.

Dai Zhi is fifty years old, and he eats this set the most, his eyes narrowed, and he said, "Xiao Feng...... Something?"

"Director, the application sent by our factory before, the 'reply letter' has not yet been issued. The factory director had a meeting yesterday and scolded me for being a bloody dog, if you don't help me, I ...... I can't help it. Feng Manrong has completely entered the coquettish mode, and by the standard of 85 years, she is already numb.

Dai Zhi smiled involuntarily, beckoned, and said, "Come in and sit down, I'll find it for you, which reply letter?"

"It's the 'Lybodine' drug. People in Germany and the United States have used it for several years, and our factory director has to talk about the agency to come over. I said that it will be released this year. Feng Manrong didn't say much about this, sat opposite Dai Zhi's desk, took an empty teacup, grabbed the tea leaves and poured water, and did it in one go. This is the advantage of female salesmen, Dai Zhi squinted and saw it, and he didn't think there was anything wrong, and he was replaced by a male salesman, and now he is facing the end of being beaten out or thrown out.

Dai Zhijaw said, "You said that I will know if you say that the law is fixed." That letter should be for Commissioner Yang. ”

"I went to his office several times and couldn't find it. I really can't help it, so I came to you. ”

"Commissioner Yang should have gone on a business trip. Dai Zhi still didn't call him by his name. This is the rule he set for himself, so as not to call it out in private and offend people by calling it out to his face. He is not familiar with Yang Rui's character, but in his mind, Yang Rui, who is only 2o years old, must be very sensitive to his own identity when he becomes famous, and from the perspective of his identity, no matter whether Yang Rui is sensitive or not, he is called Yang Rui by one more word than Yang Rui, and he is tired and immortal.

Feng Manrong smiled and followed Dai Zhi's salutation: "I heard from Member Yang's subordinates that he seems to have returned to his hometown to supervise the project of Huarui Pharmaceutical Factory. It's been half a month, and it seems that I won't be able to come back for a while. ”

Dai Zhi tasted it all of a sudden, and said with a smile: "The deadline for the reply letter has arrived, right?"

Feng Manrong smiled silently.

The GMP committee is based on the model of the West - there is nothing to learn from if you don't learn from the West now, and the Soviet Union has begun to learn from the West as it sees itself, and China can only follow what the West has already done.

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

The reply letter is a proper noun, and in the West, the drug administration has the right to respond freely and has the obligation to respond within a time limit.

Pharmaceutical companies, on the other hand, have the right to disclose whether or not to partially disclose the response letter. In short, if the content of the reply letter is favorable to the pharmaceutical company, or in part beneficial to the pharmaceutical company, the pharmaceutical company can disclose all or part of it, and if the content of the reply letter is unfavorable to the pharmaceutical company, the pharmaceutical company can not disclose it, or still disclose it in part.

Moreover, pharmaceutical companies do not need to do what is required in the reply letter, which is not mandatory, and some pharmaceutical companies feel that the US Drug Administration's response letter is not friendly, so they can go to the UK to apply for marketing as if they had nothing to do, or the process is reversed.

The system that has been copied in a hurry in China will naturally not go out of its way to revise the time limit for the reply letter.

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

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

"Good. Xiao Wang put down what he was doing and immediately went to a pile of letters and rummaged through them.

After a while, three similarly looking document bags were taken by Xiao Wang.

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

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

"Okay, there you go. Dai Zhi turned his head and said to Feng Manrong: "No way, the committee members are very busy." You understand. ”

"Understand, understand, understand. What can Feng Manrong say, she wants to get the reply now, and then hand it over to her colleagues who run the Ministry of Health for the next step. ”

Dai Zhi is an old institution, so he was not in a hurry to hand over the things to Feng Manrong, but took out the three document bags in turn.

"This letter belongs to Member Fan Yuanwei Fan. Dai Zhi picked up the top document and looked at it, and seemed to check the signature carefully, put it aside, and said with a smile: "Well, it will be approved." ”

"Thank you, thank you. ”

"This letter is from Song Hongxi and Song Committee Member...... Yes, it is approved. ”

"Thank you, thank you. ”

"This is the ...... of Member Yang Ruiyang Well, quasi-...... Not passed?" Dai Zhi couldn't help but widen his eyes.

"How ......" Feng Manrong's voice was also stuck.

She hurriedly looked up at Dai Zhi, and now that his expression was not a joke, she couldn't help but be startled, and asked, "What reason?"

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

"And then?" Feng Manrong asked.

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

"That's it?" Feng Manrong was anxious and asked, "What does he mean by this." ”

Dai Zhi's expression turned into a poker game, and he said: "Commissioner Yang said very clearly, he will not pass, please supplement the test." ”

"Didn't two more committee members pass it? Two votes to one, it should also be passed. ”

"The rules of the GMP committee are a one-vote veto system, not a minority obeying the majority. ”

Feng Manrong's head was hot, and the previous training was completely forgotten, and he said angrily: "It's easy for him to veto, he said a word, our whole factory has been busy for several months......?"

Dai Zhi interrupted Feng Manrong's words, put on a straight face, and said: "Representative Feng, this is the decision of Committee Member Yang, and our office cannot interfere. ”

"Director Dai......"

"There's nothing I can do about it. Dai Zhi shook his head.

The staff in the back were also stunned, but fortunately, they all had eyesight, no one dared to watch the play, and they dragged Feng Manrong out first.

"In the future, representatives of pharmaceutical companies will not be allowed to enter the office without my permission. Dai Zhi waited for the door to close and announced a new discipline.

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

This is the first "rejection" letter since the establishment of the gmp committee.

It is conceivable that the Jingxi Pharmaceutical General Factory, which has invested a lot of money, will not give up.

……