Rebirth of the God-level Xueba

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

The permanent staff of the GMP committee are the six staff in this 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.

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

Dai Zhi also likes to have dinner with the big girls and young wives in the Maternal and Child Health Hospital. Although he can't do anything, he just chats and takes a look, and he is always happy. In addition, he does not need to spend his money on the things sent by major pharmaceutical factories.

"Master Li, I want a tofu brain, fried dough sticks, another bowl of soy milk, and some side dishes." Dai Zhi walked into the canteen of the Maternity and Child Health Hospital from the side door and greeted the people inside with ease.

Master Li saw that it was Dai Zhi, and immediately wiped the oil hand on the apron, and said with a smile: "Director Dai is here, I will scoop his tofu brain, tofu brain, you can't just dig a spoon, you have to chip it. , You know? The tofu brain is not thin, not thick, but strong..."

He talked about his tofu brain sutra mysteriously and mysteriously, then brought it to Dai Zhi, and said with a smile: "I like Director Dai the most, you are a eater like you, know how to eat, you can eat good things without wasting them."

Dai Zhi smiled and sniffed his nose, then took a sip of tofu brain with a spoon, nodded, and said, "Water in Yuquan Mountain?"

"Awesome." Master Li put his apron in one hand, raised one hand, shaking three times, and said: "Representative Feng from the Jingxi Pharmaceutical General Factory sent it over and put it at the entrance of our cafeteria at 5 o'clock in the morning."

Dai Zhi nodded: "Jingxi Pharmaceutical General Factory has built a sanatorium in Yuquan Mountain. 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 cursed in his heart, “Officials don’t treat people as people”, and smiled on his face: “That’s right, they get up earlier and open up. It’s not particularly troublesome to come by a car."

Dai Zhi glanced at Master Li and nodded calmly, as if he was talking about tofu brains.

The representatives of the pharmaceutical factory changed their methods to please the committee members and the staff in the committee's office. It was not a news. When Dai Zhi started, he was a little uncomfortable, but now he has become accustomed to it.

After all, they have too many things that affect the lifeline of the pharmaceutical factory, and the representatives of the pharmaceutical factory get up at two o'clock in the morning to receive and deliver water.

Dai Zhi thought to himself: If I were the director of a pharmaceutical factory, as long as everything went well, how about hiring someone to deliver water.

He ate his own breakfast with peace of mind, and asked for a heart-wrenching boiled egg back to the office, ready to eat hungry at noon.

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

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

When Director Dai returned to the office slowly, an early-rising pharmaceutical factory representative had already arrived in the corridor.

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

"Director Dai."

"Director Dai!"

"Morning, Director Dai."

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

"director!"

"The director is back."

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

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

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

Dai Zhixin said, "This representative Feng looks a little bit nice from the back."

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

"Director..." Feng Manrong's voice has a bit of babbling from a TV series in Hong Kong and Taiwan, and a little bit of coquetry, but if you look carefully, it doesn't seem to be.

Dai Zhi is fifty-year-old, and he eats this one the most. He narrowed his eyes and said, "Xiao Feng...what's the matter?"

"Director, the letter of application sent by our factory before, the'Response Letter' hasn't come out yet. The director of the factory had a meeting yesterday and scolded me so bloody. If you don't help me, I...I don't have it. It's a way." Feng Manrong has completely entered the coquettish mode. By the standard of 1985, it 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 drug'Lubodin'. It has been used in Germany and the United States for several years, and our factory manager is going to come over at the agency. It is good to be listed this year." Feng Manrong will not 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 salesperson. Dai Zhi squinted his eyes and saw that there was nothing wrong with him. When he changed to a male salesperson, he was already facing the ending of being beaten or thrown out.

Dai Zhi nodded, and said, "I know if you say the law is good. That letter should be for Committee Member Yang."

"I went to his office for a few times, but I couldn't find it. I couldn't help but I came to you."

"Commissioner Yang should have gone on a business trip." Dai Zhi still did not call his name directly. This is the rule he set for himself, so as not to get used to calling out in private and to offend people by calling out in person. He is not familiar with Yang Rui’s character, but when he thinks about it, Yang Rui, who is only 20 years old, must be very sensitive to his identity when he is only 20 years old. From the perspective of his identity, whether Yang Rui is sensitive or not, it’s just that Yang Rui is called committee member. One more word than Yang Rui, so tired.

With a smile on her face, Feng Manrong followed Dai Zhi and said, "I heard from Committee Member Yang’s subordinates that he seems to have gone back to his hometown to supervise the construction of the Huarui Pharmaceutical Factory. It has been half a month, and it seems that he won’t return for a while. not coming."

Dai Zhi tasted it at once, and smiled: "The deadline for the reply letter has arrived, isn't it?"

Feng Manrong smiled without saying a word.

The GMP committee is based on the Western model-now there is nothing to learn if you don't learn from the West. The Soviet Union saw that it was starting to learn from the West. Naturally, China can only follow the West's existing things.

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

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

The pharmaceutical company has the right to disclose, or even part of the reply letter. In short, if the content in the reply letter is beneficial to the pharmaceutical company, or partly beneficial to the pharmaceutical company, the pharmaceutical company can disclose it in whole or in part, and if the content in the reply letter is not conducive to the pharmaceutical company, The pharmaceutical company may not disclose it, or still partially disclose it.

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

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

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

Dai Zhi didn't take it seriously either, beckoned, and said, "Xiao Wang, you can find the reply letter from Jingxi Pharmaceutical General Factory, the law is guaranteed!"

"Okay." Xiao Wang put down the work in his hand and immediately turned to a pile of letters.

After a while, Xiao Wang brought three paper bags that looked almost the same.

"Why don'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 delivered today, and we also unpacked it just now."

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

"Understand and understand." What Feng Manrong can say, she now wants to reply with the answer and pass it to the colleague who runs the Ministry of Health for the next step. "

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

"This letter belongs to Member Fan Yuanwei." Dai Zhi picked up the top document and looked at it, and then seemed to check the signature seriously, put it aside, and said with a smile: "Well, approval is granted."

"Thanks a lot."

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

"Thanks a lot."

"This one belongs to Member Yang Ruiyang...Well, surely...I won't pass it?" Dai Zhi couldn't help but his eyes widened.

"Much..." Feng Manrong's voice was also suddenly stuck.

She hurriedly raised her head to look 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 testing is too small, and the safety of clinical trials is doubtful. It is recommended to supplement the safety clinical testing." Dai Zhi said every word.

"Then what?" Feng Manrong asked.

"No, just such a sentence." Dai Zhi replied.

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

Dai Zhi's expression turned into poker, and he said, "Commissioner Yang made it very clear. It will not be passed. Please supplement the test."

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

"The rules of the GMP committee are a one-vote veto system, and it is not that the minority obey the majority."

Feng Manrong’s head became hot, and the training he had received before was completely forgotten, and she froze, “It’s easy for him to veto a vote. He said, our whole factory has been busy for a few months for nothing? Now the raw materials are all in vain. When we are ready, we just waited for the approval of production. The people in our factory run all lost a circle..."

Dai Zhi interrupted Feng Manrong~www.wuxiaspot.com~ with a straight face, and said: "Representative Feng, this is Committee Member Yang’s decision. Our office cannot interfere. I suggest you go back to the factory to discuss it. Right."

"Director Dai..."

"I can do nothing." Dai Zhi shook his head.

The staff at the back were also dumbfounded. Fortunately, they all had the price of insight and no one dared to watch the show. They dragged Feng Manrong out in twos or twos.

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

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

Since the establishment of the GMP committee, this is the first "not approved" reply letter.

It is conceivable that the Jingxi Pharmaceutical General Factory, which has invested heavily in it, will not give up.

...