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    Chinese medicine generic name naming technology guidelines

    INFORMATION

    Chinese medicine generic name naming technology guidelines

    Classification:
    Industry News
    Release time:
    2018/05/22
    [Abstract]:
    On November 28, the State Food and Drug Administration issued the "Circular on Publishing Guiding Principles for the Universal Naming of Chinese Patented Drugs," and issued a "Circular on Regulating t

    On November 28, the State Food and Drug Administration issued the "Circular on Publishing Guiding Principles for the Universal Naming of Chinese Patented Drugs," and issued a "Circular on Regulating the Naming of Commonly Named Chinese Patented Drugs." The issuance of the two documents not only embodies respect for the traditional cultural features of the proprietary Chinese medicines, but also makes the naming medicine scientifically standardized. It is clearly stated that the naming of Chinese patent medicines should adhere to scientific conciseness, avoid duplicate names, regulate naming, avoid exaggerating curative effects, and reflect the principle of traditional cultural characteristics.

    For listed Chinese patent medicines, the General Administration of China has clarified three situations in which the name must be renamed, that is, the effect is obviously exaggerated and the doctor and patient are misled; the name is incorrect and unscientific; there are vulgar language and superstition; the prescription is the same and the drug name is different. Drug names are the same or similar and prescriptions are different. For drug names, there are place names, names, and surnames. The name of the drug is "Bao", "Precise", "Spirit", etc. However, the variety has a certain history of use. It has formed a brand and is generally accepted by the public. It may not be renamed. Various proprietary Chinese medicine preparations originating from ancient classical names are not renamed.

    The State Pharmacopoeia Commission will organize experts to put forward a list of listed Chinese medicines that need to be renamed. After the new generic name is approved, a two-year transitional period will be given. In the transitional period, the new name will be followed by the old name and the patient and the doctor will be gradually adapted.

    With regard to the use of manuals and labels, the “Notice on regulating the naming of generic names of listed Chinese patent medicines” has also made clear and reasonable provisions. That is, within 30 days from the date of approval of the change of name, production enterprises should report to the local provincial food and drug administration. Departments filed new instructions and labels after the change of name. Drugs produced since the date of filing shall not continue to use the original instructions or labels. If the drug produced before the filing is valid for a period of 2 years, the drug can continue to use the original instructions and labels until the end of the validity period; if the validity period exceeds the transition period of 2 years, the drug can continue to use the original instructions and labels until the end of the transitional period.