Precisely because he realised that the other party might have really encountered no small difficulty, Wei Liang was not the least bit angry at the other party’s tardiness.
On the contrary, he nodded very understandingly and politely said, “It’s alright Mr. Smith, I don’t have anything else to do, I’m not in a hurry.”
“Thanks!” James Smith said thank you and smiled politely before sitting down in front of Wei Liang.
After the two of them casually ordered some meals, James Smith then asked Wei Liang, “Mr. Wei has come so far from China, is there something important?”
Wei Liang smiled, “Our Jiu Xuan Pharmaceutical, Mr. Smith should have heard of it, 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 was busy saying, “The review cycle has pa*sed for quite a long time and it hasn’t entered the next stage yet, so I would like to inquire if there is any way to speed up the process.”
Smith said with difficulty, “The FDA’s review of imported drugs is very strict now, and the process is really long, and I can’t tell you definitively whether it will meet our standards and be approved for marketing after going through all the processes.”
Wei Liang explained, “Mr. Smith, the ingredients of our Chinese medicine are very safe, and there are no toxic side effects, and the medicine is very effective, so it can be said to have immediate effects, could this medicine also be rejected by the FDA?”
Smith nodded and said, “We have been receiving drug applications from Eastern countries in recent years, and the vast majority of them are for this kind of proprietary Chinese medicine you mentioned, not only from China, but also from Japan and Korea, but the vast majority of them have been rejected.”
Wei Liang asked in disbelief, “Why is that?”
Smith said very seriously, “Mr Wei, our testing as well as vetting requirements for drugs in the West are very different from traditional medicine in the East, and one of the very important points is that there must be a clear pharmacokinetic test.”
“You must tell us clearly what the active ingredients of this drug are, for what reasons, what kind of effect it has, and you must also tell us whether this drug has any toxic side effects in the body, on various organs, especially the liver and kidneys, and how long the metabolic cycle of its ingredients in the body is, if these are not clear, there is no way we can allow it to enter If these are not clear, there is no way we can allow it to be sold in our market.”
Wei Liang said, “Many Chinese medicines are very complex in their composition, so their internal components are also very complex, unlike Western medicines, which are mostly chemical drugs, where there is often only one active ingredient, such as penicillin and aspirin, where a molecular formula can reflect its actual composition and composition, and it is very difficult for all Chinese medicines to meet such requirements in the West. seek common ground while preserving differences?”
Smith shook his head and said, “I’m sorry Mr. Wei, this is something we can’t do to seek common ground while preserving differences, the rules are the rules, all drugs that are to enter the American market must in principle meet all our rules or they can’t be marketed and sold.”
Wei Liang was busy saying, “Our drug is extremely effective, which is recognized by all patients, and it is a best-selling drug in many countries. As far as I know, many American patients have purchased our Jiu Xuan Stomach San through proxy purchase, but this method not only takes a long time, but also costs much more, and they all hope very much that the FDA will be allowed to enter the American market as soon as possible. ”
Smith shook his head and said, “Many patients themselves can’t tell whether your medicine has a definite therapeutic effect or a strong superficial symptom relief, if it’s the former it’s fine, but if it’s the latter it will probably also delay the treatment of the actual lesion.”
Speaking of this, Smith added: “This is like a kind of hemorrhoid suppository that is very popular in your China, some patients in the United States bought it through online shopping as well as black market channels and felt good using it, and it has been hoping to pa*s the FDA’s review, but we have not been able to pa*s its application, do you know why?”