What the provincial health standard needs to pass is the domestic drug application specification.

Before 99 years, China did not have the standard word of national medicine, and the power to approve drugs was in the hands of the provincial drug authorities.

The difficulty of its passage is like fighting flies and tigers compared to the criticized FDA.

Not to mention the 70s, the 80s, that is, in the 90s, how many doctors of medicine, chemistry and biology are there in provinces and autonomous regions like Ning@xia?

Not to mention, without the help of double-blind clinical trials, there is a need for more and more professional knowledge - in fact, it is not enough. A genius doctoral student who graduated 10 years ago and became a tenured professor at a prestigious university does not dare to say that he has such judgment.

In the end, whether the drug can pass or not, and whether it can get the provincial health standard, is just a bureaucratic judgment.

In the 90s, China actually did not train a few qualified technocrats, anyway, they all looked at the face, so it didn't matter the connotation.

Of course, bureaucratic standards are not necessarily easier than academic standards, but considering the number of provincial health standards issued every year, it is quite easy for Yang Rui's medicine to pass, even if it is a relatively strict Jingwei standard.

Yang Rui only hesitated: "This is a new drug, something happened, and the problem is even bigger than that of Lu Boding." ”

The most passed word of provincial health is Chinese patent medicine, and most of them are prescriptions, that is, drugs that have been proven to be okay by history, and they can be regarded as passing the clinical trials of the people, but the data is 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 don't think there should be any problem with this medicine. ”

"Can you see this?" Yang Rui pouted.

"If there was no stealing of medicines, our phase II clinical trial would have gone very smoothly, and there would be no problems at all. The only side effect, which now also proves, is not a bad thing. Huang Mao paused for a moment, and said with a smile: "It just so happens that its effect on lowering blood pressure is not obvious, and there are almost no side effects." ”

Yang Rui couldn't help laughing.

This is indeed a very funny thing, thanks to sildenafil's antihypertensive effect is not obvious, otherwise, it is still a trouble to use it for viagra.

I couldn't take the pills and was in the hotel, and as a result, I fainted with low blood pressure.

Although sildenafil still has some side effects, especially dizziness and blueness, these side effects are pediatric compared to the strong blood pressure lowering that Pfizer expects.

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

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

On the contrary, the over-the-counter drug Viagra, which has no side effects, can be sold like a sugar pill - selling the drug like a sugar pill, and selling the drug to everyone is the dream of almost any pharmaceutical company.

For this purpose, all clinical tests of sildenafil should stand up to scrutiny.

"The second phase of clinical trials must be strictly completed, and then whether to apply for domestic drug approval is considered. Yang Rui made a compromise and explained to Huang Mao: "As long as we announce that we will soon conduct domestic testing and domestic sales, many people will be relieved." They just can't wait a few years, not a few months. ”

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

Thinking of the role of sildenafil, Huang Mao smiled unkindly.

Indeed, for some long-term difficult households, a few months can still wait.

"However, what should I do if I call directly like this?" Huang Mao asked again. People are of high rank, and they are really not willing to wait.

"You said that our clinical trials are declared to the FDA, and the principle of openness and transparency is strictly observed, and all information of the people involved in the test must be reported to the FDA, which is impossible for us to hide and deceive, and the other party will also have irregular investigations. Yang Rui paused for a moment, and then said: "When the domestic test begins, we will give priority to inviting them." ”

This reason stands up to scrutiny.

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

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

On the other hand, it is indeed easy to be reassuring to pass the clinical phase II test, and it is easier to pass the domestic audit.

There are many cases where foreign drugs are sold in their own country first, and then apply for the US FDA after they are sold, but just like Yang Rui said, the order needs to be arranged.

"The reason for openness and transparency is good, and in this case, all senior cadres will be excluded. Huang Mao breathed a sigh of relief. Although he has long since stopped working in the system, the pressure is still indispensable.

Yang Rui nodded and said, "Not only high-level cadres, but also middle-level cadres. Limited to the following sub-divisions. ”

"Hey, is that okay?"

"Why not, the health status of cadres is also very important information, is it the right thing to let foreign institutions directly obtain it?" Yang Rui said, he felt very reasonable, and said: "Call Gengxin and ask him how he said it is appropriate." ”

"Okay. Huang Mao was also excited, with such a big hat to cover, the trouble would definitely be reduced.

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

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

Huang Mao also said happily: "This is good, the direction we are doing now is a little more special, and it is better to have fewer big people." ”

"It's less now, and it's going to be less than ever. Yang Rui pouted. This is the second phase of the clinical trial, and the third phase of the clinical trial is larger in scale and more people, even if it is restricted, the domestic drug review is always indispensable to make concessions.

It's just that from Yang Rui's point of view, he doesn't really care who participates in the clinical trial, as long as the second phase has passed, it can be determined that this sildenafil is pisidenafil. I have to say that it is due to Yang Rui's academic habits, for fear that Pfizer will stumble and make a compound with different functional groups and named sildenafil, otherwise, if another person appears, he will definitely not be so careful.

However, good academic habits are all about being consistent. If you think that there is no problem with a drug, you will be excited to promote it, instead of doing strict double-blind clinical practice, what is the difference between it and engaging in traditional Chinese medicine.

Everyone thinks that what they have made is good, just look at the self-promoting folk scientists inside and outside the campus of Peking University, claiming that they have broken through the law of conservation of energy, made a perpetual motion machine organization, and can be equipped into a regiment - so many high-level super Einstein figures, no one even thought of building a small workshop with high energy consumption, upgrading step by step to become a private big boss, and merging Peking University with only the starry sky, it is really ...... It's worrying.

Sildenafil is the most concerned drug in China and even internationally, and procedural justice is indispensable.

The test subjects, selected from more than 20,000 people, quickly filled the clinical trial center of Hedong University.

The eyes of all parties come either publicly, secretly, or privately betting.

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