Chapter 914

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

GMP The standing staff of the committee are the six staff members in the office of the Standing Committee. Because the number is too small, they discussed with the maternal and child health hospital next door to share a canteen.

Maternal and child health care hospital is naturally willing to, after all, everyone likes to have free things to send.

Dai Zhi also likes to have dinner with the big girls and little daughters-in-law in the maternal and child health hospital. Although he can't do anything, he just chats and has a look. He is always in a better mood. What's more, we don't need to spend his money on the things sent by the major pharmaceutical companies.

"Master Li, I want a bean curd, fried dough sticks, and a bowl of soybean milk. I'll have some small dishes." Dai Zhi walked into the canteen of the maternal and child health hospital from the side door and said hello to the people inside.

As soon as Master Li saw that it was Dai Zhi, he immediately rubbed his oil hand on his apron and said with a smile, "director Dai is here. I'll scoop his bean curd. Bean curd is not just a scoop. You have to slice it, don't you know? Scooping bean curd is not thin, not thick, but rich in taste... "

He talked about his tofu brain classics, then brought it up to Dai Zhi, and said with a smile: "I like director Dai. You are such a diner. You know how to eat and you know how to eat. Good things are for you. It's not wasteful."

Dai Zhi sniffed with a smile, then scooped a mouthful of bean curd with a spoon, nodded and said, "the water of Yuquan mountain?"

"Great." Master Li held his apron in one hand, raised his hand, shook it three times, and said, "it was sent by representative Feng of Jingxi pharmaceutical factory, and it was put at the gate of our canteen at five o'clock in the morning."

Dai Zhi nodded: "Jingxi pharmaceutical factory has built a sanatorium in Yuquan mountain. It's 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 that "officials don't treat people as people." he said with a smile: "it's also true. They get up earlier and drive a car. It's not too much trouble."

Dai Zhi takes a look at Master Li and nods calmly. It seems that what he just talked about is bean curd.

It's not news that representatives of pharmaceutical companies try to curry favor with the committee members and the staff of the committee members' office. Dai Zhi was not used to it at first, but now he is used to it.

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

Dai Zhi thought: if I'm the director of a pharmaceutical factory, as long as everything goes well, what if I hire someone to deliver water.

He ate his breakfast at ease and ordered a soft boiled egg to go back to the office, ready to be hungry at noon.

Now he pays more attention to health preservation. At noon and in the evening, if there is no dinner, he eats very little.

Of course, there is little time for no dinner.

When director Dai slowly came back to the office, there were already early pharmaceutical representatives in the corridor.

Most of these people come to ask for progress and "reply letter". With the reply letter from GMP Committee, the subordinate departments of the Ministry of health will review the market entry application. That's another long process. However, compared with foreign counterparts, these pharmaceutical companies still belong to state-owned enterprises are still happy.

"Director Dai."

"Director Dai!"

"Good morning, director Dai."

The representatives greet Dai Zhi one after another. He smiles and walks into the office like a leader of inspection work.

"Director!"

"The director is back."

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

Dai Zhi waved his hand and his eyes fell on his back in front of his desk.

Standing in front of the partition is Feng Manrong of Jingxi pharmaceutical factory.

Dai Zhixin said: "this representative Feng looks at his back. It's still a little good-looking."

He stopped and looked for two seconds, then coughed and said, "representative Feng? Can I help you? "

"Director..." Feng Manrong's voice is a little whine of Hong Kong TV series, a little coquetry flavor, but if you look at it carefully, it seems not.

Dai Zhi, a 50 year old man, was the one who ate the most. His eyes narrowed and he said, "Xiao Feng, what's the matter?"

"Director, the" reply letter "of the application form sent by our factory has not come out yet. The director of the factory held a meeting yesterday and scolded me bloody. If you don't help me any more, I'll... I can't help it. " Feng Manrong has completely entered the coquetry mode. By the standards of 85 years, she is already numb.Dai Zhi couldn't help but smile, waved and said, "come in and sit down. I'll show you which reply letter?"

"It's the drug" lubodin. ". It has been used in Germany and the United States for several years, but our factory director wants the right of agency. It's agreed that it will be listed this year. " Feng Manrong didn't say much when she said that. She sat across from Dai Zhi's desk, took an empty tea cup, grabbed the tea and poured it. This is the advantage of a female salesman. Dai Zhi squints at it and doesn't think it's bad. If he changes to a male salesman, he will be beaten or thrown out.

Dai Zhihan nodded his head and said, "I'll know if you say that LV boding. That letter should have been given to member Yang. "

"I went to his office several times and couldn't find it. I have no choice but to come to you. "

"Member Yang should have gone on a business trip." Dai Zhi still didn't call him by his first name. This is the rule he made for himself, so as not to get used to it in private and offend others in person. He is not familiar with Yang Rui's character. However, in his mind, Yang Rui, who is only 20 years old, must be very sensitive to his own identity when he becomes famous. From the perspective of his identity, whether Yang Rui is sensitive or not, he is more tired than Yang Rui.

With a smile on her face, Feng Manrong followed Dai Zhi and said, "I heard from the subordinates of member Yang that he seems to have gone back to his hometown to supervise the project of Huarui pharmaceutical factory. It's been half a month. It seems that I won't be able to come back for a while. "

Dai Zhipin immediately tasted it and said with a smile, "the deadline for the reply letter has arrived, right?"

Feng Manrong was silent with a smile.

GMP The committee is based on the model of the West. Now there is nothing to learn if we do not learn from the West. The Soviet Union has begun to learn from the west, and China can only learn from the West.

According to the Western model, when a pharmaceutical company applies for the listing of a drug, the FDA or any other abbreviated drug administration will give a reply within a limited time. The reply document is called the reply letter.

Reply letter is a proper term. In the west, the drug administration holds the right to reply freely and undertakes the obligation to reply within a time limit.

Pharmaceutical companies have the right to disclose, or even part of, their replies. In short, if the content in the reply letter is beneficial to the pharmaceutical company, or partially beneficial to the pharmaceutical company, the pharmaceutical company can make it public in whole or in part. If the content in the reply letter is unfavorable to the pharmaceutical company, the pharmaceutical company can not make it public, or still make it public in part.

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 US Drug Administration's reply letter is unfriendly, so they can go to the UK to apply for listing as if nothing has happened, or reverse the process.

In China, the system that has been copied in a hurry will not change the time limit of the reply letter.

In fact, foreign drug administrations have a series of complicated problems. They often feel that time is not enough. There is no such problem in China.

Dai Zhi didn't take it seriously. He waved and said, "Xiao Wang, go to find the reply letter from Jingxi pharmaceutical factory, LV boding!"

"Good." Xiao Wang put down his work and immediately turned it over in a pile of letters.

After a while, three similar file bags were brought by Xiao Wang.

"Why don't you give it to the factory in advance?" Dai Zhi made a pretentious criticism.

Xiao Wang explained in a low voice, "member Yang's letter was delivered today, and we just disassembled it."

"All right, you go." Dai Zhi turned to Feng Manrong and said, "I can't help it. The committee members are very busy. You understand

"Understand, understand." What can Feng Manrong say? Now she wants to take the reply letter and give it to her colleagues in the Ministry of health for the next step. "

Dai Zhi is an old organ. Instead of rushing to hand things over to Feng Manrong, he takes out three paper bags in turn.

"This letter belongs to member fan Yuanwei." Dai Zhi picked up the top document and looked at it. He seemed to check his signature carefully. He put it aside and said with a smile, "yes, I'm allowed to pass."

"Thank you very much."

"This letter belongs to song Hongxi, member of the song Committee. Well, it's approved."

"Thank you very much."

"This one belongs to member Yang Ruiyang... En, it's not allowed to pass?" Dai Zhi's eyes widened.

"More..." Feng Manrong's voice was jammed.

She quickly looked up at Dai Zhi and found that his expression was not a joke. She was startled and asked, "what's the reason?""The scope of animal toxicity test is too small, and the safety of clinical trial is questionable. It is suggested to supplement the safety clinical test." Dai Zhi read it word by word.

"And then?" Asked Feng Manrong.

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

"That's it?" Feng Manrong was worried and asked, "what does he mean?"

Dai Zhi's expression turned into a poker, said: "member Yang said very clearly, did not pass, please supplement the test."

"Didn't two other members pass? Two to one, it's time to pass. "

"The rule of GMP committee is one vote veto system, not that the minority is subordinate to the majority."

Feng Manrong's head was so hot that she forgot all the training she had received. She said angrily, "it's easy for him to vote down. In a word, how many months have we been working in vain? Now that all the raw materials are ready, we are waiting for the approval of the production. All the long-distance runners in our factory have lost a lap... "

Dai Zhi interrupted Feng Manrong and said with a straight face: "representative Feng, this is the decision of member Yang. Our office can't interfere. I suggest that you go back to the factory to discuss it."

"Director Dai..."

"There's nothing I can do." Dai Zhi shakes his head.

The staff at the back were also stunned. Fortunately, they all had insight. No one dared to see the play. They dragged Feng Manrong out first.

"In the future, without my permission, representatives of pharmaceutical factories are not allowed to enter the office." Dai Zhi and others closed the door and announced the new discipline.

The staff sat back in silence and expressed their shock with their eyes and expressions.

Since the establishment of the GMP Committee, this is the first "no" reply.

It can be imagined that Jingxi pharmaceutical factory, which has invested a lot of money, will not give up.

……