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, "Do you have a drug that is being reviewed by our FDA?"
"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 refused 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
was 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 the metabolic cycle of its ingredients in the body, we will not be able to allow it to enter the Chinese market.
"
Wei Liang hurriedly said: "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 extremely 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 lesions.