Chapter 1519

What Provincial Health approval word needs to pass is the domestic drug application specification.

Before 1999, there was no national drug approval in China, and the power of drug approval was in the hands of provincial drug authorities.

Compared with the criticized FDA, it is just like beating flies and tigers.

Let alone the 1970s and 1980s, that is to say, how many doctors of medicine, chemistry and biology are there in provinces and autonomous regions like Ning @ Xia?

Even the corresponding level of doctoral students are not, throw a drug out, how many undergraduates can understand the pharmacokinetics? Needless to say, without the help of double-blind clinical trials, more professional knowledge is needed, which is not enough. Talented doctoral students who have graduated for 10 years and become tenured professors in famous universities dare not say that they have such judgment.

Finally, whether the drug can pass or not and whether it can get the Provincial Health approval is just a bureaucratic judgment.

In the 1990s, China did not train a few qualified technocrats. Anyway, they all looked at the face, so it didn't matter what the connotation was.

Of course, the bureaucratic standard is not necessarily easier than the academic standard. However, considering that there are so many provincial health standards issued every year, it is quite easy for Yang Rui's drugs to pass even the strict Jingwei standard.

Yang Rui only hesitated: "it's a new drug. Something's wrong. It's bigger than the problem of lamivudine."

Most of them are Chinese patent medicines, and most of them are proven prescriptions. That is to say, the medicines proved to be safe by history have also passed the clinical trials of the people, but the data are not collected, the mortality rate is easy to control, and the side effects are difficult to contact.

In contrast, only a few hundred people have taken pure sildenafil.

Huang Mao said: "we'll follow the rules completely... Besides, I don't think there's any problem with this medicine."

"Can you see that?" Yang Rui turned his mouth.

"If we didn't steal the medicine, our second phase clinical work would be very smooth, and there was no problem at all. The only side effect, as it turns out, is not a bad thing. " Huang Maodun for a while, and said with a smile: "just its effect of lowering blood pressure is not obvious, almost no side effects."

Yang Rui couldn't help laughing.

This is really a very funny thing, thanks to sildenafil antihypertensive effect is not obvious, otherwise, it is still a trouble to use it to do Viagra.

I can't take the pills. I'm in the hotel. Hi, I've got hypotension and fainted.

Although sildenafil still has some side effects, especially dizziness, blue eyes and so on, compared with Pfizer's strong antihypertensive effect, these side effects are pediatrics.

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

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

On the contrary, the over-the-counter drug Viagra, which has no side effects, can be sold like a sugar pill. It is almost the dream of all pharmaceutical companies to sell drugs to everyone like a sugar pill.

To this end, all clinical trials of sildenafil should stand up to scrutiny.

"Phase II clinical 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 that domestic testing and domestic sales will be carried out soon, many people will feel at ease. They just can't wait years, not months. "

With 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 role of sildenafil, Huang Mao also laughed unkindly.

Indeed, for some households with long-term difficulties, they can still wait a few months.

"But what if you call directly like this?" Huang Mao asked again. They are of a high level, and they really don't want to wait.

"You just say that our clinical trials are reported to the FDA. We strictly abide by the principle of openness and transparency. All information of those who participate in the tests must be reported to the FDA. This is impossible for us to hide and cheat. The other party will also have irregular investigations." Yang Rui stopped for a moment, and then said, "when the domestic test starts, we will invite them first."

This reason is worthy of investigation.

If Yang Rui doesn't talk about the domestic test, in order to use the drug a few years in advance, it really can't be said. Will anyone ask Yang Rui to ignore the FDA's requirements.

Correspondingly, if the delay is only a few months, the pressure must be much less.On the other hand, it's really easy to pass the second phase clinical test, and it's also easier to pass the domestic audit. It's the so-called "sharpening the knife without mistaking the firewood cutter".

There are many cases in which foreign drugs are sold in China first, and then applied to the FDA of the United States. But as Yang Rui said, it is necessary to arrange the order. If there is any scandal, it will make the FDA audit more difficult.

"It's a good reason to be open and transparent. In this case, all senior cadres will be excluded." Huang Mao was relieved. Although he has not been working in the system for a long time, there is still a lot of pressure.

Yang Rui nodded and said, "not only senior cadres, but also middle-level cadres. Limit the number of vice offices to below. "

"Why, is that ok?"

"Why not? The health status of cadres is also very important information. Is it right for foreign organizations to obtain it directly?" Yang Rui said, he felt very reasonable, and said: "call Bo Geng Xin, ask him how to say appropriate."

"All right." Huang Mao also cheered up. With such a big hat, the trouble will surely be reduced.

In a moment, Huang Mao returned from his office with a telephone line plugged in. With a smile on his face, he learned from Geng Xin's expressionless eyes and said, "party members, cadres at the level of deputy branch or above should not be allowed to participate."

"Well, that's it." Yang Rui immediately made a decision.

Huang Mao is also happy to say: "this is good. The direction we are doing now is more special. It's better to have fewer big people."

"It's less now, and it will not be less later." Yang Rui turned his mouth. This is the second phase of clinical trials. The third phase of clinical trials has a larger scale and a larger number of people. Even if there are restrictions, there are always concessions in domestic drug examination.

Just from Yang Rui's point of view, he actually doesn't care who will participate in the clinical trial, as long as the second phase has passed, it can be determined that this sildenafil is that of the sildenafil. It has to be said that Yang Rui's academic habits made him afraid that Pfizer would stumble and make a compound with different functional groups, which would also be named sildenafil. Otherwise, he would not be so careful if another person appeared.

However, good academic habits should be carried out from beginning to end. What's the difference between those who think a medicine has no problem and those who are excited to promote it without strict double-blind clinical practice.

Everyone thinks that what they have made is good. Just look at the folk scientists who have promoted themselves inside and outside the campus of Peking University. They claim that they have broken the law of conservation of energy, created a perpetual motion machine organization, and can be equipped into a group, It's really... Urgent to upgrade step by step to be a big boss of private enterprises and merge Peking University, which only controls the starry sky.

Sildenafil is the most concerned drug in China and even in the world. Procedural justice is indispensable.

The subjects selected from more than 20000 people soon filled the clinical experiment center of Hedong University.

The eyes of all parties, or open, or secret, or private bets.