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,"
is okay, but if the latter, it is likely to also delay the treatment of the actual
from China, some patients in the United States through online shopping, as well as black market channels,
also feel very good, and it has also been hoping to pass the FDA review, but we have not been through its
in disbelief: "Then
of hemorrhoid suppositories, the use of some cool analgesic ingredients, this kind of
it just can relieve pain, in our opinion, these ingredients not only can not really treat the lesion, but
warning some time ago, reminding patients using this drug to pay attention to
to sell very hot in China, which is said to be a special cold medicine made with
drug, what really plays a therapeutic role are two western ingredients, one is a common drug to reduce fever and analgesia, acetaminophen;" "And another is
his hands, serious and with a few helpless expressions, "Mr. Wei, I am also not deliberately against you, or against the entire Eastern traditional
about it, if you, JX Pharmaceutical, also casually use some plant ingredients, and then
claim to the public that this is a kind of Chinese medicine that can effectively lower blood sugar, then do
very rigorous discipline, must be clear, clear to be,
"Mr. Smith, I do not deny what you just said these things, there are a few
not be all rejecting because there have been such cases, all the Eastern traditional medicine drugs are beaten to death, there are still many, many excellent
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