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    Home > Medical News > Latest Medical News > I'll take the tablet reference capsule

    I'll take the tablet reference capsule

    • Last Update: 2016-08-03
    • Source: Internet
    • Author: User
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    There is a song called "I bet my youth on tomorrow" Today, yaozhijun is going to talk about "I take tablets to compare Capsules" How can I compare them? It's nonsense that someone immediately laughs when using capsule as reference preparation of tablet? How to compare different dosage forms? Which regulation is OK? Which leader said it was ok? Yaozhijun asked himself: which laws and regulations said it was not, which leader said it was not, the speech of the highest leader that can be seen at present (speech of director Bi at the meeting of conformity evaluation of generic drugs in June 2016): " These objective circumstances do exist But why should we use the varieties that have been delisted abroad? Why did the original product change the dosage form and specification when it came to us? These opinions should be analyzed in detail "The main responsibility of looking for the reference preparation is the enterprise, and the industry associations of the General Administration and the Provincial Bureau should provide guidance and help If there is any dispute over the reference, the general administration may organize experts to discuss it publicly " Although the current CFDA is not willing to change the dosage form and salt (although it was the CFDA that encouraged drug companies to change the dosage form, issued new drug certificates and gave preferential policies), it is also said that specific analysis is needed, which can be discussed publicly, and no one is killed There are some experts who are not from enterprises When it comes to specific problems, they directly suggest that enterprises give up from the overall situation of the industry However, it is painful to know that each product is a piece of meat on the enterprise! The rights are won Since CFDA does not explicitly stipulate that it is not allowed to take similar dosage forms as reference, as a pharmaceutical enterprise, if there are such varieties: the original research only has capsules, and they sell tablets themselves The sales are still good, and they are not willing to give up the market, then use tablets to compare capsules Because there is a certain scientific basis for the comparison of similar dosage forms: in CDE electronic publication (2012.01.14) (http://db.yaozh.com/policies/5308.html), it is said that "generic application of simple modified dosage form products: Although this situation is generic application, the target of the generic application is the product after the modified dosage form, but in order to avoid the influence of error transmission and superimposed factors on the results, be test The reference preparation should select the original dosage form product of the original R & D enterprise, rather than the imitated marketed modified dosage form product The selection of reference preparations when changing Salt Varieties on the market can also refer to this principle " There is no qualitative difference between tablets and capsules In FDA, some new drugs use capsules in phase II and tablets in phase III (in order to save time and money, no effort has been made to optimize the dosage form in the early stage), which is not bad For a brand-new imitation of a drug, of course, there is no need to eat enough to hold on, and change the original capsule into tablet But for the varieties that have been modified and have been approved for many years, yaozhijun doesn't think it's necessary to be so demanding, isn't it necessary to do be, and repeatedly emphasize the importance of be? Is it OK that my tablet and capsule be are not the same? Don't say that there is too much policy risk In fact, the risk is very small We have CFDA to endorse it! According to the management method of reference preparation filing, although many matters in China are called filing, the essence is approval The selection of reference preparation needs CFDA's final confirmation As long as he approves, we can safely carry out the test There is no need to carry out a penny test for reference preparation filing (Declaration) It's just research and writing Even if the record is not recognized, it is also successful (proving its infeasibility, saving everyone's repeated tangles, saving many brain cells of many people, boundless credit)
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