Millionaire Son in Law Chapter 3750
Please read this chapter to continue with the story.
- A Western official outlines stringent drug testing and review requirements for market entry.
- The complexity of traditional Eastern medicine compositions presents challenges for Western regulatory standards.
- Discussions highlight the global appeal of JX Stomach powder versus its hurdles for U.S. market approval.
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,”
“If the former is okay, but if the latter, it is likely to also delay the treatment of the actual lesion.”
Speaking of which, Smith added: “It’s like there 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 these drugs,”
“Use them down also feel very good, and it has also been hoping to pass the FDA review, but we have not been through its application, you know why?”