Chapter 1811 Much better
Chapter 1811 is much better
It is because I realized that the other party might really encounter a lot of difficulty, so Wei Liang was not angry because of the opponent's lateness.
On the contrary, he nodded very well, politely: "Mr. Smith, okay, I have nothing else, not in a hurry."
"Thank you!" James Smith said gratefully, smiling politely, and then sitting in front of Wei Liang.
The two ordered some meals at will, and James Smith asked Wei Liang: "Is there something important to come from Huaxia so far?"
Wei Liang laughed: "We Jiu Xuan Pharmaceutical, Mr. Smith should hear it?"
"I heard." Smith nodded and said, "Do you have a medicine in our FDA review?"
"Yes." Wei Liang said busy: "The review cycle has passed for a long time, and it has not yet entered the next stage, so I want to consult, do you have any way to speed up."
Smith said embarrassedly: "Now the FDA's review of imported drugs is very strict. This process is indeed long, and I can't tell you clearly. After all the processes are completed, whether it meets our standards, can it be allowed to be listed on the market
. ""
Wei Liang explained: "Mr. Smith, our Chinese medicine, its composition is very safe, there are no toxic and side effects, and the effect is good. It can be said that this medicine will be rejected by the FDA?
"?"
Smith nodded and said: "In recent years, we have received drug applications from Eastern countries, and most of them are the Chinese medicines you said. Not only Chinese, Japan and South Korea have submitted a lot, but most of them have
Rejected. "
Wei Liang asked puzzled: "Why is this?"
Smith said very seriously: "Mr. Wei, our Western testing and review requirements for drugs are very different from traditional Oriental Medicine. The very important point is that there must be a clear drug dynamic test."
"You must clearly tell us what effective ingredients are this drug, what is the reason for what kind of role, and we must also tell us that this drug is in the body, to various organs, especially liver and kidney, is there any organs, whether
Poisonous side effects, how long its composition is metabolized in the body. If these are unclear, we can't get it to enter the market in our country. "
Wei Liang was busy: "Many Han prescriptions, the prescriptions of the prescription are very complicated, so the internal components are also very complicated. Unlike western medicine, most of the oxye is chemical, and the active ingredients often have only one, such as penicillin, aspirin, and a molecular formula can reflect the molecular formula.
Out of its actual component and composition, it is difficult to meet this requirement of the West, but isn't this necessary to find the same difference? "
Smith shook his head and said, "Sorry, Mr. Wei, we can't achieve common ground while depositing differences. The regulations are that all drugs to enter the US market must meet all our rules in principle, otherwise we cannot be sold for sale.
"
Wei Liang was busy: "Our drugs are very effective. This is recognized by all patients. In many countries, it is a best -selling medicine. As far as I know, many American patients buy our Jiu Xuan stomach through purchasing, but
This method not only has a long time, but the cost is much higher, and they all hope that the FDA can be approved as soon as possible to enter the US market. "
Smith shook his head and said, "Many patients cannot distinguish whether your medicine has a clear treatment effect, or it has a strong effect of alleviating on the surface symptoms. If it is the former, it is okay to say.
It will also delay the treatment of actual lesions. "
Speaking of this, Smith said again: "This is like a hemorrhoid embolism that is very popular in Huaxia. Some American patients bought it through online shopping and the black market channels.
The review, but we have not passed its application, do you know why? "
Wei Liang asked puzzled: "Why is that?"
Smith said: "In our opinion, in the kind of hemorrhoid embolism, some cool and analgesic ingredients are used. This ingredient can relieve the pain, but it can only relieve pain. In our opinion, these ingredients
Not only can not really treat the lesion, but it is also likely to cover up the disease because of this, which delays the scientific treatment of the patient. Therefore, we also released a warning some time ago, reminding patients using this drug to pay attention to scoring, do not because of because of the identification, do not because
Surface symptoms to alleviate and ignore core issues. "
"In addition, we have also studied some kinds of binding tablets that once sold in Huaxia. It is said to use honeysuckle, forsythia with special effects of cold medicines made of western medicine components."
"It can be found that in our research, the medicine that really plays the treatment is two types of western medicine ingredients, one is a commonly used medicine for fever and analgesic, which is acetaminol; and one is specifically used to relieve allergies.
, Rhinitis and sneezing, runny nose and other symptoms, poker sensitivity, the two of them are combined to treat fever, cold and runny nose. "
Speaking of this, Smith spread his hands, solemn and helplessly said: "Mr. Wei, I don't deliberately target you, or to the traditional medicine of the entire East."
"But if you think about it, if you have some plant ingredients, you can use some plant components, and then match the western medicine composition that can control blood sugar, and then declare it to the outside world that this is a Chinese medicine that can effectively reduce blood sugar, then you you
Do you think we might be approved this drug to go public? "
"This is why, we have always been very cautious about Oriental medicine. Medicine is a very rigorous discipline. We must be clear and clear.
Wei Liang also felt a little embarrassed. He said with a scalp and said, "Mr. Smith, I don't deny these things you just said. There are a few so -called Han prescriptions, or medicines combined with things.
But I think that you can't kill all the traditional Oriental Medicine medicines because of such a case. There are still many excellent medicines in traditional Oriental Medicine. "
Smith nodded: "Of course I don't deny this, but what I want to say is that even if it is an excellent Oriental traditional medicine, it must be entered the Chinese market under the premise of meeting all our FDA requirements. Therefore, you, you, you
If you want to enter the US market for sales, we must first understand all its components, as well as the purpose and potential danger of each component. "
Wei Liang asked: "If you just said just now, the component of many Chinese medicines is too complicated, and it may not be clear that there are several ingredients.
OK one by one? "
Smith shrugged: "If you can't be sure one by one, then we can only pass it."
Wei Liang asked again: "Even if you know that this medicine is very effective, but because you cannot completely determine the ingredients and functions, do you refuse it to go on sale?"
"Yes." Smith said categorically: "Our attitude is like this. Even if this medicine is really effective, we must not be listed before we did not understand it."
Wei Liang couldn't help asking: "Don't you think, is this the loss of the American people?"
"Loss?" Smith said in a somewhat contempt: "Mr. Wei, to be honest, all the oriental medicines I know currently have a large number of alternatives in the United States, and it is still safer and more efficient.
Replacement! "
"Whether it is about headache and brain fever, or all organs, blood vessels and nervous systems, including the heart, liver, spleen, lungs and kidney, you have in traditional medicine in Eastern medicine, we have western medicine, and our western treatment methods are better than you or East.
The treatment methods are much better !! "
Chapter completed!