Chapter 1811 Much better
It was precisely because he realized that the other party might have encountered something very difficult that Wei Liang was not angry at the time of the other party's lateness.
On the contrary, he nodded with great understanding and said politely: "Mr. Smith is fine, I have nothing else to do, so don't worry."
"Thank you!" James Smith thanked, smiled politely, and then sat in front of Wei Liang.
The two ordered some meals at will, and James Smith asked Wei Liang: "Is there anything important about Mr. Wei coming from China so far?"
Wei Liang smiled and said, "Mr. Smith must have heard of us Jiuxuan Pharmaceuticals?"
"I've heard of it." Smith nodded and said, "You have a drug for review in our FDA, right?"
"Yes." Wei Liang hurriedly said: "The review cycle has been a long time and has not yet entered the next stage, so I would like to ask if there is any way to speed up the pace."
Smith said in embarrassment: "FDA is now very strict in reviewing imported drugs. This process is indeed very long, and I cannot tell you clearly whether it meets our standards and whether it can be approved for marketing after completing all the processes."
Wei Liang explained: "Mr. Smith, our Chinese patent medicine has very safe ingredients and no toxic side effects. It is also very effective. It can be said that it will be immediate. Will this medicine be rejected by FDA?"
Smith nodded and said, "We have been receiving drug applications from Eastern countries in recent years, and most of them are the Chinese patent medicines you mentioned. Not only China, Japan and South Korea have submitted a lot, but most of them have been rejected."
Wei Liang asked in confusion: "Why is this?"
Smith said very seriously: "Mr. Wei, our Western drug testing and review requirements are very different from traditional Eastern medicine. One very important point is that there must be clear pharmacokinetic tests."
"You must tell us clearly what the effective ingredient of this drug is, what reasons, and what role it plays. We must also tell us whether this drug has toxic side effects on various organs, especially the liver and kidneys, and how long the metabolism cycle of its components in the body. If we don't understand these, we will not be able to obtain permission to enter the Chinese market for sale."
Wei Liang hurriedly said: "Many Chinese prescriptions and medicines have very complex prescription composition, so the internal components are also very complex. Unlike Western medicines, most of them are chemical drugs, and there is often only one active ingredient, such as penicillin and aspirin. A molecular formula can reflect its actual components and composition. It is difficult for all Chinese patent medicines to meet the requirements of the West, but shouldn't we seek common ground while reserving differences?"
Smith shook his head and said, "Sorry, Mr. Wei, we cannot seek common ground while reserving differences in this regard. The regulations are regulations that all drugs that want to enter the US market must in principle comply with all our rules, otherwise they will not be available for sale."
Wei Liang hurriedly said: "Our drug has excellent results, which is recognized by all patients. It is a best-selling drug in many countries. As far as I know, many American patients buy our Jiuxuanwei San through purchasing agents. However, this method not only takes a long time, but also has a much higher cost. They also hope that FDA can obtain approval from this drug to enter the US market as soon as possible."
Smith shook his head and said, "Many patients themselves cannot tell whether your medicine has a clear therapeutic effect or a strong effect of relieving surface symptoms. If it is the former, it is okay, but if it is the latter, it may delay the treatment of the actual lesions."
Speaking of this, Smith said: "This is like a very popular hemorrhoid tumour in China. Some patients in the United States bought it through online shopping and black market channels. It feels good to use it. And it has always hoped to pass the FDA review, but we have not passed its application. Do you know why?"
Wei Liang asked in confusion: "Why is that?"
Smith said: "Because in our opinion, some cool and analgesic ingredients are used in the hemorrhoid tumour. This ingredient can relieve pain, but it can only relieve pain. In our opinion, these ingredients not only cannot truly treat the lesions, but may also cover up the condition, 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 and not to ignore the core issues because of the relief of surface symptoms."
"In addition, we have also studied something that was once very popular in China and combined with tablets. It is said to be a special cold medicine made of honeysuckle, forsythia and some Western medicine ingredients."
"But our research has found that among those drugs, there are two Western medicine ingredients that really play a therapeutic role. One is a common medicine for antipyretic pain, acetaminophen; and the other is a drug specially used to relieve allergies, rhinitis, sneezing, runny nose and other symptoms. Palmin. The combination of these two can just treat fever, cold and runny nose."
Speaking of this, Smith spread his hands and said seriously and helplessly: "Mr. Wei, I am not deliberately targeting you, or traditional medicine in the entire East."
"But think about it, if you Jiuxuan Pharmaceuticals also use some plant ingredients, and match them with the Western medicine ingredient metformin that can control blood sugar, and then declare to the public that this is a Chinese patent medicine that can effectively lower blood sugar, do you think we may approve this drug on the market?"
"This is why we have always been very cautious about Oriental medicines. Medicine is a very rigorous discipline. We must be clear and clear, and we must not piece together irresponsibly."
Wei Liang also felt a little embarrassed and said, "Mr. Smith, I don't deny that the things you just said are a few so-called Chinese prescriptions or medicines that combine things. They are indeed suspected of selling dog meat with sheep's head. But I think you cannot kill all traditional Eastern medicine drugs just because of such a case. There are still many excellent medicines in traditional Eastern medicine."
Smith nodded: "I certainly don't deny this, but what I want to say is that even excellent traditional oriental medicines must meet all our requirements to enter the Chinese market. Therefore, if your medicine wants to enter the US market, we must first understand all its ingredients, as well as the uses and potential dangers of each ingredient."
Wei Liang asked back: "If the ingredients of many Chinese patent medicines are too complicated, and they may not be explained clearly by just a few ingredients, and even dozens or hundreds of them are needed, how can we determine them one by one?"
Smith shrugged: "If we can't determine one by one, then we can only fail."
Wei Liang asked again: "Even though I know that this medicine is very effective, Is it because I cannot completely determine the ingredients and effects, so will you refuse it to be sold?"
"Yes." Smith said firmly: "This is our attitude. Even if the medicine is really effective, it will never be available until we understand it."
Wei Liang couldn't help asking: "Don't you think this is also a loss to the American people?"
"Loss?" Smith said in a somewhat contemptuous tone when he heard this: "Mr. Wei, to be honest, we in the United States have a large number of alternatives to all the Oriental medicines I know so far, and they are safer and more efficient alternatives!"
Chapter completed!