Just because he realized that the other party might really have encountered some difficulties, Wei Liang was not angry at all because of the other party's lateness.

On the contrary, he nodded very understandingly and said politely: "It's okay, Mr. Smith, I don't have anything else to do, so I'm not in a hurry."

"Thank you!" James Smith thanked him, smiled politely, and then sat in front of Wei Liang.

The two casually ordered some meals, 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 said hurriedly: "The review cycle has passed for a long time, and it has not entered the next stage yet, so I would like to ask if there is any way to speed up the process."

Smith was very embarrassed and said: "Now the FDA is very strict in reviewing imported drugs. The process is indeed very long, and I can't tell you clearly whether it meets our standards after going through all the processes and whether it can be approved for marketing."

."

Wei Liang explained: "Mr. Smith, the ingredients of our proprietary Chinese medicine are very safe, have no side effects, and are very effective. It can be said to have immediate effects. Could it be that this kind of medicine will also 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 the kind of proprietary Chinese medicines you mentioned. Not only China, but also Japan and South Korea have submitted many, but most of them are

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 Eastern traditional medicine. One of the most important points is that there must be clear pharmacokinetic testing."

"You must tell us clearly what the active ingredients of this drug are, for what reasons, and what role it plays. You must also tell us whether this drug has any effect on various organs in the body, especially the liver and kidneys.

If we don’t understand the toxic and side effects and how long the ingredients take to be metabolized in the body, we won’t be able to allow it to enter the Chinese market.”

Wei Liang said hurriedly: "Many Chinese medicines have very complex prescriptions, so the internal ingredients are also very complex. Unlike Western medicines, which are mostly chemical drugs, there is often only one active ingredient, such as penicillin and aspirin, which can be expressed in a single molecular formula.

Without revealing its actual ingredients 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 on this point. The regulations are regulations. In principle, all drugs that want to enter the U.S. market must comply with all our rules, otherwise they cannot be marketed.

"

Wei Liang said hurriedly: "Our medicine is very effective, which is recognized by all patients. It is a best-selling medicine in many countries. As far as I know, many American patients buy our Jiuxuanweisan through purchasing agents, but

This method not only takes a long time, but also costs much more. They also hope that the FDA can approve this 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 is the former, it is easy to say, but if it is the latter, it is very likely that

It will also delay the treatment of the actual disease.”

Speaking of this, Smith added: "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. They feel good after using it, and they have always hoped to pass the FDA's approval."

Review, but we have never approved its application, do you know why?”

Wei Liang asked in confusion: "Then why?"

Smith said: "Because in our opinion, some cooling and analgesic ingredients are used in that hemorrhoid suppository, which can relieve pain for patients, but it can only relieve pain. In our opinion, these ingredients

Not only is it unable to truly treat the lesions, but it is also likely to cover up the condition, thus delaying the scientific treatment of patients. Therefore, we also issued a warning some time ago, reminding patients who use this drug to pay attention to screening and not to

Alleviation of superficial symptoms while ignoring core issues.”

"In addition, we have also studied a certain combination of tablets that was very popular in China. It is said to be a special cold medicine made from honeysuckle, forsythia and some western medicine ingredients."

"But after our research, we found that the real therapeutic effect of that drug is two Western medicine ingredients, one is a commonly used drug for reducing fever and analgesia, acetaminophen; and the other is specially used to relieve allergies.

, drugs for rhinitis, sneezing, runny nose and other symptoms, chlorpheniramine, the combination of the two can just treat fever, cold and runny nose.”

At this point, Smith spread his hands and said seriously and somewhat helplessly: "Mr. Wei, I am not deliberately targeting you, or the entire Eastern traditional medicine."

"But think about it, if your Jiuxuan Pharmaceutical casually uses some plant ingredients, and then mixes it with metformin, a Western medicine ingredient that can control blood sugar, and then claims to the outside world that this is a Chinese patent medicine that can effectively lower blood sugar, then you

Do you think we are likely to approve this drug?"

"This is why we have always been very, very cautious about oriental medicines. Medicine is a very rigorous subject. It must be clear and understandable, and it cannot be irresponsibly pieced together."

Wei Liang also felt a little embarrassed and said bravely: "Mr. Smith, I don't deny what you just said. There are a small number of so-called Chinese medicines, or medicines that combine Eastern and Western medicines. They are indeed selling sheep's meat to dogs.

But I think you can’t just beat all traditional oriental medicine drugs to death just because there have been 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 medicine drugs must meet all the requirements of our FDA before they can enter the Chinese market. Therefore, you

If a drug wants to be sold in the U.S. market, we must first understand all its ingredients, as well as the uses and potential dangers of each ingredient."

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.
Chapter completed!