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 of people is too small, they discussed with the maternal and child health hospital next door to share a canteen.

Maternal and child health care centers are naturally very happy. After all, everyone likes to send them for free.

Dai Zhi also likes to have dinner with the older girls and wives of the maternal and child health hospital. Although he can't do anything, he just chats and takes a look and feels happy. Moreover, the things given by major pharmaceutical factories don't have to spend his money.

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

Master Li saw that it was Dai Zhi, and immediately wiped his oily hand on the apron and said with a smile: "Director Dai is here. I will scoop his tofu brain. Tofu brain, it's not just dig a spoon. You have to shave slices, do you know? Scooping tofu brain is not thin, not thick, but strong..."

He talked mysteriously about his tofu brain scripture, then brought it to Dai Zhi, and said with a smile: "I like diners like Director Dai the most. They know how to eat and know how to eat good things for you, so you won't waste them."

Dai Zhi smiled and sniffed, then scooped a bite of tofu brain with a spoon, nodded, and said, "The water in Yuquan Mountain?"

"Awesome." Master Li put on an apron with one hand, raised his hand, shook it three times, and said, "Representative Feng from Jingxi Pharmaceutical Factory sent it here and put it at the entrance of our canteen at 5 a.m.."

Dai Zhi nodded: "Jingxi Pharmaceutical Factory has built a sanitary center in Yuquan Mountain, which makes it easy for them to get water."

Seeing that Dai Zhi didn't care about details like five in the morning, Master Li cursed in his heart, "Officials don't regard people as humans" and smiled, "That's right, they got up earlier and drove over, it's not a big trouble."

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

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

After all, they have too many things that affect the lifeline of pharmaceutical factories. What is the difference between the representatives of pharmaceutical factories getting up at 2 o'clock in the morning to receive water and deliver water?

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

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

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

Of course, there is very little time without dinner.

When Director Dai slowly returned to the office, there were already early-washing pharmaceutical factory representatives coming in the corridor.

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

"Director Dai."

"Director Dai!"

"It's early for Director Dai."

The delegates greeted Dai Zhi one after another, and he smiled slightly, like a leader inspecting the work, pushed 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 hand and his eyes fell on the back of his desk.

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

Dai Zhixin said: "This representative Feng looks a bit good when he looks at his back."

He stood and looked for two seconds, then coughed and said, "Representative Feng? Is there anything wrong?"

"Director..." Feng Manrong's voice was a little bit like a Hong Kong and Taiwan TV series, and a little bit of a coquettish smell, but if you savor it carefully, it seemed that there was no such thing.

Dai Zhi is fifty years old and is the most greedy for this trick. His eyes narrowed and said, "Xiao Feng...is there something wrong?"

"Director, the 'reply letter' sent by our factory has not been released yet. The factory director held a meeting yesterday and scolded me for being so bloody. If you don't help me, I... I have no choice." Feng Manrong completely entered the coquettish mode. By the standard of 1985, it was already very stingy.

Dai Zhi couldn't help but smile, waved his hand, and said, "Come in and sit down, I'll look for you, which reply letter?"

"It's the medicine of 'Lu Boding'. Germany and the United States have been using it for several years. Our factory manager has been trying to persuade him to come. It is agreed to be launched this year." Feng Manrong didn't say much after talking about this. She sat opposite Dai Zhi's desk, took an empty tea cup, grabbed the tea leaves and poured water, and finished it in one go. This is the advantage of a female salesperson. Dai Zhi squinted his eyes and didn't think there was anything wrong with it. If he was a male salesperson, he was now facing the ending of being beaten or throwing it out.

Dai Zhi nodded and said, "I will know if you say Lu Boding. That letter should be given to Committee Member Yang."

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

"Committee Yang must have gone on a business trip." Dai Zhi still didn't call him directly. This was the rule he set for himself to avoid getting used to calling him in private and offending others. He was not familiar with Yang Rui's personality, but in his opinion, Yang Rui, who was only 20 years old, must be very sensitive to his identity when he became famous. From the perspective of his identity, no matter whether Yang Rui is sensitive or not, calling Member Yang is one more word than Yang Rui, which is so exhausting.

Feng Manrong smiled and also said to Dai Zhi: "I heard from the subordinates of Member Yang that he seemed to have returned to his hometown to supervise the project of Huarui Pharmaceutical Factory. It took half a month to do so, and it seems that he will not be able to come back for a while."

Dai Zhi tasted it all at once and smiled and said, "The deadline for the reply letter is here, right?"

Feng Manrong smiled and said nothing.

The GMP committee was based on the Western model - now there is nothing to learn if you don’t learn the West. The Soviet Union saw that it had begun to learn the West, so naturally China could only draw pictures based on what the West has.

According to the Western model, when a pharmaceutical company applies for a drug market, the FDA or other abbreviation of the Drug Administration must give a reply within a limited time. The reply document is called a reply letter.

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

The pharmaceutical company has the right to make public or even partially public 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 make full or partly public. If the content in the reply letter is harmful to the pharmaceutical company, the pharmaceutical company can not make any public or partly public.

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 think that the reply letter from the US Drug Administration is unfriendly, so they can apply for marketing in the UK as nothing has happened, or turn this process in reverse.

The system that has been plagiarized in a hurry in China will naturally not specifically modify the time limit for reply letters.

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

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

"Okay." Xiao Wang put down the work in his hand and immediately flipped through the pile of letters.

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

"Why don't you hand it over to the factory in advance?" Dai Zhi criticized it in a pretentious manner.

Xiao Wang whispered: "Committee Yang's letter was sent today, and we just opened it."

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

"Understand." What can Feng Manrong say? She wants to get the reply letter now and hand it over to her colleagues who went to the Ministry of Health to proceed to the next step."

Dai Zhi was an old agency and was not in a hurry to hand over the things to Feng Manrong, but took out three file bags in turn.

"This letter belongs to Member Fan Yuanwei and Fan." Dai Zhi picked up the top document and looked at it, seemed to carefully check the signature, put it aside, and smiled and said, "Yes, it will be approved."

"Thank you, thank you."

"This letter is from the member Song Hongxi and Song... 六, and it is approved."

"Thank you, thank you."

"This is from Member Yang Rui and Yang... Well, it's accurate... it won't be approved?" Dai Zhi couldn't help but widen his eyes.

"Many..." Feng Manrong's voice suddenly became stuck.

She hurriedly looked up at Dai Zhi, and found that his expression was not a joke. She was shocked and asked, "What's the reason?"

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

"What then?" Feng Manrong asked.

"No more, just one sentence." Dai Zhi replied.

"Just that's the case?" Feng Manrong was anxious and asked, "What does he mean?"

Dai Zhi's expression turned into poker, saying, "Committee Yang said it very clearly. If you don't pass it, please give it a supplementary test."

"Aren't there two committee members who passed it? Two votes to one vote, it should be passed."

"The rules of the GMP committee are vetoed, not the minority obeys the majority."

Feng Manrong's head became hot, and she forgot all the training she had received before, and said angrily: "It was simple for him to veto it. In one sentence, our whole factory has been working in vain for several months? Now that the raw materials are ready, we are just waiting to approve production. The people who run the factory in charge have lost a lot of weight..."

Dai Zhi interrupted Feng Manrong and said with a stern face, "Representative Feng, this is the decision of Member Yang. Our office cannot interfere. I suggest that you should go back to the factory to discuss."

"Director Dai..."

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

The staff behind were also stunned. Fortunately, they were all jealous and no one dared to watch the show, so they dragged Feng Manrong out in just a few seconds.

"In the future, without my permission, the pharmaceutical factory representatives will not be allowed to enter the office." Dai Zhi and others closed the door and announced new disciplines.

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

Since the establishment of the GMP Committee, this is still the first reply letter to "not be approved".

It can be imagined that the Jingxi Pharmaceutical General Factory, which has invested a huge amount of money, will not give up.

...
Chapter completed!