Chapter: 3203
On the contrary, he nodded understandingly, and said politely, "It's okay, Mr. Smith, I don't have anything else to do, don't worry."
"Thank you!" James Smith thanked him, smiled politely, and then sat in front of Wei Liang.
The two ordered some meals at random, and James Smith asked Wei Liang: "Mr. Wei came so far from China, is there anything important?"
Wei Liang smiled and said, "Mr. Smith should have heard of our Jiuxuan Pharmaceutical, right?"
"I've heard of it." Smith nodded and said, "You have a drug that is being reviewed by our FDA, right?"
"Yes." Wei Liang hurriedly said: "The review cycle has passed for a long time, and it has not yet entered the next stage, so I would like to ask if there is any way to speed up."
Smith was very embarrassed and said: "The FDA's review of imported drugs is very strict now. The process is really long, and I can't tell you clearly whether it meets our standards and whether it can be approved for marketing after going through all the processes. .�
Wei Liang explained: "Mr. Smith, our Chinese patent medicine has very safe ingredients, no side effects, and the effect is very good. It can be said that it can be said to be effective immediately. Will this medicine be rejected by the FDA? ?�
Smith nodded and said: "We have been receiving drug applications from eastern countries in recent years, and most of them are Chinese patent medicines you mentioned. Not only China, but also Japan and South Korea have submitted many applications, but most of them are got rejected."
Wei Liang asked in confusion, "Why is that?"
Smith said very seriously: "Mr. Wei, our Western medicine testing and review requirements are very different from Eastern traditional medicine. One of the very important points is that there must be a clear pharmacokinetic test."
"You must tell us clearly what the active ingredient of this drug is, what is the reason, and what kind of effect it has played, and you must also tell us whether this drug has any effect on various organs in the body, especially the liver and kidney. Toxicity and side effects, how long is the metabolism cycle of its ingredients in the body, if these are not clear, we will have no way to allow it to enter the Chinese market."
Wei Liang hurriedly said: "Many Chinese medicines have very complex prescriptions, so the internal components are also very complicated. Unlike Western medicines, which are mostly chemical drugs, there is often only one active ingredient, such as penicillin and aspirin. One molecular formula can reflect It is difficult for all Chinese patent medicines to meet the requirements of the West, given its actual ingredients and composition, but shouldn�t this be seeking common ground while reserving differences?�
Smith shook his head and said, "I'm sorry, Mr. Wei, we can't seek common ground while reserving differences on this point. Regulations are regulations. In principle, all drugs that want to enter the US market must comply with all our rules, otherwise they cannot be marketed. "
Wei Liang hurriedly said: "Our medicine is very effective, which is recognized by all patients, and it is a best-selling medicine in many countries. As far as I know, many American patients have purchased our Jiuxuanwei powder through purchasing agent, but This method not only takes a long time, but also costs a lot more, and they all hope that the FDA will allow the drug to enter the US market as soon as possible."
Smith shook his head and said: "Many patients themselves can't tell whether your medicine has a clear therapeutic effect or a strong superficial symptom relief effect. If it's the former, it's okay to say, but if it's the latter, it's very likely. It will also delay the treatment of the actual lesion."
Speaking of this, Smith said again: "This is like a hemorrhoid suppository that is very popular in China. Some patients in the United States bought it through online shopping and black market channels. It feels good after using it, and it has always hoped to pass FDA approval. Review, but we have never passed its application, do you know why?"
Wei Liang asked puzzledly, "Then why?"
Smith said: "Because in our opinion, some cooling and analgesic ingredients are used in the hemorrhoid suppository. This ingredient can relieve the patient's pain, but it can only relieve the pain. In our opinion, these ingredients Not only can it not really treat the lesion, but it may also cover up the disease, thus delaying the patient's scientific treatment. Therefore, we also issued a warning some time ago, reminding patients who use this drug to pay attention to screening, not because of Relief of superficial symptoms while ignoring core problems."
"Besides, we have also researched some combination tablets that were once very popular in China. It is said that it is a special cold medicine made of honeysuckle and forsythia combined with some western medicine ingredients."
"But after our research, we found that in that drug, there are two western medicine ingredients that really play a therapeutic role. One is acetaminophen, a commonly used drug for reducing fever and analgesia; the other is specially used to relieve allergies. , rhinitis, sneezing, runny nose and other symptoms, chlorpheniramine, the combination of the two can just treat fever, cold and runny nose."
Speaking of this, Smith spread his hands, and said solemnly and somewhat helplessly: "Mr. Wei, I didn't deliberately target you, or the entire traditional oriental medicine."
"But think about it, if you, Jiuxuan Pharmaceutical, use some plant ingredients casually, and then mix it with metformin, a western medicine ingredient that can control blood sugar, and then claim to the outside world that this is a Chinese patent medicine that can effectively lower blood sugar, then you Do you think there's a chance we'll get this drug approved?"
"That's why we've always been very, very cautious about oriental medicines. Medicine is a very rigorous discipline. It must be clear and clear, and it cannot be irresponsible and arbitrary."
Wei Liang also felt a little embarrassed, and said bravely: "Mr. Smith, I don't deny the things you just said. There are a few so-called Chinese medicines, or medicines that combine things, and they are indeed suspected of selling dog meat. But I don�t think you can kill all traditional oriental medicines just because of such cases, there are still many, 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 excellent traditional oriental medicines must meet all the requirements of our FDA before they can enter the Chinese market. Therefore, you If the drug wants to enter the US market, we must first understand all its ingredients, as well as the use and potential danger of each ingredient."
Wei Liang asked back: "Then if, as you said just now, the ingredients of many Chinese patent medicines are too complicated, it may not be possible to explain clearly with a few ingredients, or even dozens or hundreds of kinds, how can we explain it clearly?" Are you sure about it one by one?"
Smith shrugged: "If we can't determine each one, then we will have to fail."
Wei Liang asked again: "Even if you know that this drug is very effective, but because you can't completely determine the ingredients and function, are you refusing to market it?"
"Yes." Smith said decisively: "Our attitude is like this. Even if this drug is really effective, it must not be launched until we understand it." JrNovels.com
"Thank you!" James Smith thanked him, smiled politely, and then sat in front of Wei Liang.
The two ordered some meals at random, and James Smith asked Wei Liang: "Mr. Wei came so far from China, is there anything important?"
Wei Liang smiled and said, "Mr. Smith should have heard of our Jiuxuan Pharmaceutical, right?"
"I've heard of it." Smith nodded and said, "You have a drug that is being reviewed by our FDA, right?"
"Yes." Wei Liang hurriedly said: "The review cycle has passed for a long time, and it has not yet entered the next stage, so I would like to ask if there is any way to speed up."
Smith was very embarrassed and said: "The FDA's review of imported drugs is very strict now. The process is really long, and I can't tell you clearly whether it meets our standards and whether it can be approved for marketing after going through all the processes. .�
Wei Liang explained: "Mr. Smith, our Chinese patent medicine has very safe ingredients, no side effects, and the effect is very good. It can be said that it can be said to be effective immediately. Will this medicine be rejected by the FDA? ?�
Smith nodded and said: "We have been receiving drug applications from eastern countries in recent years, and most of them are Chinese patent medicines you mentioned. Not only China, but also Japan and South Korea have submitted many applications, but most of them are got rejected."
Wei Liang asked in confusion, "Why is that?"
Smith said very seriously: "Mr. Wei, our Western medicine testing and review requirements are very different from Eastern traditional medicine. One of the very important points is that there must be a clear pharmacokinetic test."
"You must tell us clearly what the active ingredient of this drug is, what is the reason, and what kind of effect it has played, and you must also tell us whether this drug has any effect on various organs in the body, especially the liver and kidney. Toxicity and side effects, how long is the metabolism cycle of its ingredients in the body, if these are not clear, we will have no way to allow it to enter the Chinese market."
Wei Liang hurriedly said: "Many Chinese medicines have very complex prescriptions, so the internal components are also very complicated. Unlike Western medicines, which are mostly chemical drugs, there is often only one active ingredient, such as penicillin and aspirin. One molecular formula can reflect It is difficult for all Chinese patent medicines to meet the requirements of the West, given its actual ingredients and composition, but shouldn�t this be seeking common ground while reserving differences?�
Smith shook his head and said, "I'm sorry, Mr. Wei, we can't seek common ground while reserving differences on this point. Regulations are regulations. In principle, all drugs that want to enter the US market must comply with all our rules, otherwise they cannot be marketed. "
Wei Liang hurriedly said: "Our medicine is very effective, which is recognized by all patients, and it is a best-selling medicine in many countries. As far as I know, many American patients have purchased our Jiuxuanwei powder through purchasing agent, but This method not only takes a long time, but also costs a lot more, and they all hope that the FDA will allow the drug to enter the US market as soon as possible."
Smith shook his head and said: "Many patients themselves can't tell whether your medicine has a clear therapeutic effect or a strong superficial symptom relief effect. If it's the former, it's okay to say, but if it's the latter, it's very likely. It will also delay the treatment of the actual lesion."
Speaking of this, Smith said again: "This is like a hemorrhoid suppository that is very popular in China. Some patients in the United States bought it through online shopping and black market channels. It feels good after using it, and it has always hoped to pass FDA approval. Review, but we have never passed its application, do you know why?"
Wei Liang asked puzzledly, "Then why?"
Smith said: "Because in our opinion, some cooling and analgesic ingredients are used in the hemorrhoid suppository. This ingredient can relieve the patient's pain, but it can only relieve the pain. In our opinion, these ingredients Not only can it not really treat the lesion, but it may also cover up the disease, thus delaying the patient's scientific treatment. Therefore, we also issued a warning some time ago, reminding patients who use this drug to pay attention to screening, not because of Relief of superficial symptoms while ignoring core problems."
"Besides, we have also researched some combination tablets that were once very popular in China. It is said that it is a special cold medicine made of honeysuckle and forsythia combined with some western medicine ingredients."
"But after our research, we found that in that drug, there are two western medicine ingredients that really play a therapeutic role. One is acetaminophen, a commonly used drug for reducing fever and analgesia; the other is specially used to relieve allergies. , rhinitis, sneezing, runny nose and other symptoms, chlorpheniramine, the combination of the two can just treat fever, cold and runny nose."
Speaking of this, Smith spread his hands, and said solemnly and somewhat helplessly: "Mr. Wei, I didn't deliberately target you, or the entire traditional oriental medicine."
"But think about it, if you, Jiuxuan Pharmaceutical, use some plant ingredients casually, and then mix it with metformin, a western medicine ingredient that can control blood sugar, and then claim to the outside world that this is a Chinese patent medicine that can effectively lower blood sugar, then you Do you think there's a chance we'll get this drug approved?"
"That's why we've always been very, very cautious about oriental medicines. Medicine is a very rigorous discipline. It must be clear and clear, and it cannot be irresponsible and arbitrary."
Wei Liang also felt a little embarrassed, and said bravely: "Mr. Smith, I don't deny the things you just said. There are a few so-called Chinese medicines, or medicines that combine things, and they are indeed suspected of selling dog meat. But I don�t think you can kill all traditional oriental medicines just because of such cases, there are still many, 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 excellent traditional oriental medicines must meet all the requirements of our FDA before they can enter the Chinese market. Therefore, you If the drug wants to enter the US market, we must first understand all its ingredients, as well as the use and potential danger of each ingredient."
Wei Liang asked back: "Then if, as you said just now, the ingredients of many Chinese patent medicines are too complicated, it may not be possible to explain clearly with a few ingredients, or even dozens or hundreds of kinds, how can we explain it clearly?" Are you sure about it one by one?"
Smith shrugged: "If we can't determine each one, then we will have to fail."
Wei Liang asked again: "Even if you know that this drug is very effective, but because you can't completely determine the ingredients and function, are you refusing to market it?"
"Yes." Smith said decisively: "Our attitude is like this. Even if this drug is really effective, it must not be launched until we understand it." JrNovels.com
~ LEAVE A COMMENT ~