Chapter 3750
Smith said very seriously, "Mr. Wei, our Western requirements for testing as well as reviewing drugs are very different from traditional Eastern medicine, and one of the very important points is that there must be a clear pharmacokinetic test."
"You must tell US clearly what is the active ingredient of this drug, for what reason, what kind of effect it plays, and you must also tell US whether this drug has toxic side effects in the body, in various organs, especially the liver and kidneys,"
"And how long is the metabolic cycle of its ingredients in the body, if these are not clear, there is no way we can allow it to enter our market sales."
Liang said, "In many Chinese medicines, the composition of their prescriptions are very complex, so the internal composition is also very complex, unlike Western medicines which are mostly chemical drugs,"
"The active ingredient is often only one, such as penicillin, aspirin, a molecular formula can reflect its actual composition and formation, all the Chinese medicines are difficult to meet the requirements of the West, but this should not seek common ground while preserving differences?"
Smith shook his head and said, "Sorry Mr. Wei, this is something we cannot do to seek common ground while preserving differences, the rules are the rules, all drugs to enter the U.S. market, in principle, must meet all our rules, otherwise they cannot be marketed and sold."
Liang was busy saying, "Our drug is extremely effective, which is recognized by all patients, and is a best-selling drug in many countries, as far as I know, many American patients are buying our JX stomach powder by way of proxy," "But this method not only takes a long time, but also costs much more, and they all hope that the FDA will allow it to enter the U.S. market as soon as possible."
Smith shook his head and said, "Many patients themselves can not tell whether your drug has a clear therapeutic effect or a strong effect of surface symptom relief,"
the former is okay, but if the latter, it is likely to also delay the treatment of the
is a very hot selling hemorrhoid suppository drug from China, some patients in the United States through online shopping, as well as black market channels, buy
also feel very good, and it has also been hoping to pass the FDA review, but we have not been through its
disbelief: "Then
opinion, that kind of hemorrhoid suppositories, the use of some cool analgesic ingredients, this kind of ingredients can let patients
relieve pain, in our opinion, these ingredients not only can not really treat the lesion, but also probably will therefore
using this drug to pay attention to screening and
have also studied that something combined with tablets that used to sell very hot in
ingredients, one is a common drug to reduce fever and analgesia, acetaminophen;" "And another is a drug specifically used to relieve
with a few helpless expressions, "Mr. Wei, I am also not deliberately against you, or against the
some plant ingredients, and then with the Western medicine ingredient metformin that can
just claim to the public that this is a kind of Chinese medicine that can effectively lower blood sugar, then do you think we are likely to approve this kind of drug
we have been very, very cautious about Oriental drugs, medicine is a very rigorous discipline, must be clear, clear to be, can not be irresponsible recklessly pieced
I do not deny what you just said these things, there are a few so-called Chinese medicines, or the combination of East
be all rejecting because there have been such cases, all the Eastern traditional medicine drugs
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