Rebirth of the God-level Xueba

What needs to be approved by the Provincial Health Commission is the domestic drug application specification.

Before 1999, China did not have a national drug standard, and the approval power of drugs was in the hands of provincial drug authorities.

Compared with the criticized FDA, its difficulty of passing is like beating a fly and a tiger.

Not to mention the 1970s, the 1980s, even in the 1990s, in provinces and autonomous regions like Ning@xia, how many doctors of medicine, chemistry, and biology have a total of?

There are not even doctoral students of the corresponding level. How many undergraduates can understand the pharmacokinetics of a drug? Not to mention, in the absence of double-blind clinical trials to assist judgment, more, more, more, and more professional knowledge is originally needed-in fact, it is not enough. A genius Ph.D. student who graduated 10 years ago and became a tenured professor at a prestigious university would not dare to say that he has such judgment.

In the end, it is just a bureaucratic judgment whether the drug can be passed and whether it can get the provincial health approval.

In the 1990s, China actually did not cultivate a few qualified technocrats. Anyway, it was all about appearances, so it didn't matter what the meaning was.

Of course, bureaucratic standards are not necessarily easier than academic standards. However, considering the number of provincial health approvals issued each year, it would be quite difficult for Yang Rui’s medicine to pass even the stricter Jingwei approval. Easy.

Yang Rui only had some hesitation: "This is a new drug, something went wrong, it's bigger than the problem with Luboding."

Most of the provincial health approvals are Chinese patent medicines, and most of them are proven prescriptions, that is, medicines that have been proven to be fine by history. They can also be regarded as passed the clinical trials of the people, but the data are not summarized, the mortality rate is easy to control, and the side effects are difficult to contact.

In contrast, the total number of people who have taken the pure new drug sildenafil is only a few hundred.

Huang Mao said: "We follow the rules completely... Besides, I think there should be no problem with this medicine."

"Can this be seen?" Yang Rui curled his lips.

"If there hadn't been any drug stealing, our Phase II clinical trials would have gone smoothly, with no problems at all. The only side effect has now been proven to be not a bad thing." Huang Mao paused, then smiled: "It just so happens The effect of lowering blood pressure is not obvious, and there are almost no side effects."

Yang Rui couldn't help laughing too.

This is indeed a very funny thing, thanks to the low blood pressure effect of sildenafil is not obvious, otherwise, it would be troublesome to use it as Viagra.

I couldn't take the pills and was high in the hotel, but I fainted due to low blood pressure.

Although sildenafil still has some side effects, especially dizziness and blue eyes, compared with the powerful blood pressure reduction expected by Pfizer, these side effects are pediatrics.

If the antihypertensive effect is obvious, the scope of application of sildenafil will be greatly narrowed, and it will become an anti-ED drug only suitable for hypertensive patients.

With such a prefix, it is not easy to sell blockbusters.

On the contrary, Viagra, an over-the-counter drug with no side effects, can be sold like a sugar pill-selling medicine like a sugar pill, and selling medicine to everyone is almost the dream of all pharmaceutical companies.

For this goal, all clinical tests of sildenafil should be able to withstand scrutiny.

"The second phase of clinical trials must be strictly completed before considering whether to apply for domestic drug approval." Yang Rui made a compromise and explained to Huang Mao: "As long as we announce, domestic testing and domestic sales will soon be carried out. They will feel at ease. They just can't wait a few years, not a few months."

As he said that, Yang Rui shook his eyebrows and said with a smile, "Isn't it good to give them a few months to find a target?"

Thinking of the effect of sildenafil, Huang Mao also smiled unkindly.

Indeed, for some long-term needy households, it is still possible to wait for a few months.

"However, what should I do if I call directly like this?" Huang Mao asked again. They are of a high level, so they may not be willing to wait.

"Just say that our clinical trials are reported to the FDA,

Strictly abide by the principle of openness and transparency. Those who participate in the test must report all information to the FDA. This is impossible for us to hide and deceive, and the other party will also conduct irregular investigations. "Yang Rui paused for a moment, and then said: "When the domestic test starts, we will invite them first. "

This reason is defensible.

If Yang Rui didn't talk about domestic testing, in order to use the medicine a few years in advance, it's really hard to say whether someone would ask Yang Rui to ignore the FDA's request.

Correspondingly, if it is only delayed for a few months, the pressure must be much less.

On the other hand, passing the second phase of the clinical test is indeed easy to make people feel at ease, and it is easier to pass the domestic review.

There are many cases where foreign drugs are sold in their own country first, and then apply to the US FDA after they are sold well, but as Yang Rui said, the order needs to be arranged. If there is any scandal, it will affect the original Difficult FDA review is even worse.

"It's good to be open and transparent. In this case, all high-ranking officials will be excluded." Huang Mao was relieved. Although he has long ceased to work in the system, the pressure is still indispensable.

Yang Rui nodded, and said: "Not only high-level cadres, but middle-level cadres are not allowed. It is limited to below the deputy department."

"Hey, is this okay?"

"Why not? The health status of cadres is also very important information. Is it the right thing to let foreign organizations obtain it directly?" Call and ask him what is appropriate."

"Okay." Huang Mao also cheered up, with such a big hat covering him, the troubles will definitely be reduced.

After a while, Huang Mao returned from the office where the telephone line was still plugged in, with a smile on his face, and in a flash, imitating Geng Xin's expressionless eyes, he said: "Party members, cadres at the deputy department level and above should not be allowed to participate .”

"Okay, just follow this." Yang Rui immediately made a decision.

Huang Mao also said cheerfully: "That's good. The direction we are doing now is a bit special. It's better to have fewer big shots."

"It's less now, and it will be indispensable in the future." Yang Rui curled his lips. This is the second phase of clinical trials. The third phase of clinical trials has a larger scale and more people. Even if there are restrictions, the domestic drug review always requires concessions.

But from Yang Rui's point of view, he doesn't really care who will participate in the clinical trial, as long as the second phase is over, it is enough to confirm that this sidenafil is the other sidenafil. It has to be said that it was due to Yang Rui's academic habits that Pfizer was afraid that he would stumble and made a compound with different functional groups and also named it sildenafil. Otherwise, if another person appeared, he would definitely not be so careful.

However, good academic habits are to be followed consistently. If you feel that there is no problem with a drug, you will be excited to promote it instead of doing strict double-blind clinical trials. That is no different from practicing Chinese medicine.

Everyone thinks that the things they make are good. Just look at the self-promoting folk scientists inside and outside the Peking University campus. They claim that they have broken through the law of energy conservation, and they have created a perpetual motion machine. Organized and equipped into a group—so many People whose level exceeds Einstein's, no one has thought of building a small energy-intensive workshop, upgrading step by step to become a private big BOSS, and annexing Peking University to only control the starry sky. It is really... anxious.

Sildenafil is the drug that has received the most attention both domestically and internationally, and procedural justice is always indispensable.

The subjects selected from more than 20,000 people quickly filled the Clinical Experiment Center of Hedong University.

The eyes of all parties come from public, secret, or private betting.

The genius remembers the address of this site in one second:. Vertex Novels mobile version reading website: