In order to strengthen registration management, further standardize the naming of Chinese patent medicines, embody the characteristics of traditional Chinese medicine, respect culture, and inherit tradition. Recently, the State Food and Drug Administration drafted the "Guidelines for the Common Name Naming Technology of Chinese Patent Medicine (Draft for Comment)" to the society. Publicly solicit opinions.
The General Administration stated that the guiding principles are based on the technical requirements and principles of the naming of common names of traditional Chinese medicines, and based on the current status of naming of proprietary Chinese medicines, combined with recent research progress on the naming of proprietary Chinese medicines, not only applicable to the naming of new Chinese medicines, but also applicable. The specification for the non-standard naming of the original proprietary Chinese medicine. For long-established drug names, if they have to be changed, they can be listed as a transition.
The guiding principles point out that the naming of proprietary Chinese medicines should be scientific and concise, avoiding duplicate names, necessary and reasonable, avoiding suggestion, exaggerating curative effect, and embodying traditional cultural characteristics as the basic principle. The naming of single-flavored preparations should generally be naming Chinese herbal medicines, traditional Chinese medicine decoction pieces, Chinese medicine active ingredients, and effective parts of traditional Chinese medicines. It can also be named after the effective ingredients of traditional Chinese medicine, effective parts of traditional Chinese medicine and functional combination; the name of artificial finished products of Chinese herbal medicine should be The names of natural products are different and should generally not be named after “artificial XX”.
The naming of the compound preparation can be abbreviated by the name of the main medicinal material of the prescription and combined with the dosage form, but the abbreviations cannot be combined to violate the meaning of other naming requirements. The main function, the number of drug tastes, the dose (injection amount, the proportion of the drug in the prescription, the single dose), the color of the drug dosage form, the name of the combined dosage form, the name of the drug or the main drug and the combination of the dosage form can be used. Name and so on.
Pediatric medication can be added to the clinical name of the drug. Under the conditions of naming principles, the naming can reflect the yin and yang five elements, the ancient academic factions (such as Taoism, legalists, etc.), the names of ancient objects, etc., in order to highlight the traditional Chinese cultural characteristics, such as: Zuojinwan, Yuquanwan.
The General Administration requested that the relevant opinions be sent to the State Food and Drug Administration by e-mail before February 15.