|
Medical network - on March 10, on March 8, the state administration of traditional Chinese medicine website issued "to" the ancient classic square directory for a selection range and the selection principle of "advice notice.
In July 1, 2017 implementation of law on the law of the People's Republic of China on Chinese medicine article 30, the production meets the conditions prescribed by the state from ancient classic square compound preparations of Chinese medicine, when applying for drug approval number, can only provide non-clinical safety study materials. This caused a high attention and discussion.
Ancient classic square directory are popular in the industry expect, during the two sessions of many medical representatives are mentioned on it. According to the notice, the document's comment until April 5.
In this document, the ancient classic square directory set selection range is defined as: the ancient medical books, published 1911 years ago. Reflect overall requirement is: "is still widely used, curative effect, has obvious characteristic and advantages". There are more ancient records and basis of the evidence, the modern literature have more clinical and experimental research reports; Get the doctor of traditional Chinese medicine clinical further refining, authoritative experts widely recognized; All kinds of widely collected in the textbooks of Chinese medicine, etc.
Look from selecting specific in principle, can be divided into five types of conditions to be fulfilled with four kinds of forbidden situation:
Meet the conditions:
1. Health demand oriented, around the advantages of traditional Chinese medicine disease to choose formula, attending to juggle has listed the conditions of the Chinese patent medicine involve less;
2. The prescription ZhongYaoWei by 2015 edition of pharmacopoeia of statutory standards;
3. The prescription is suitable for industrialized production, as medicinal properties is good;
4. Delivery way consistent with the recorded in ancient medical books;
5. The domestic varieties of unlisted.
Ban:
1. Do not contain in the prescription of the People's Republic of China pharmacopoeia 2015 edition contains toxic medicinal materials;
2. Don't involve in prescription of wildlife under special state protection kinds catalog of varieties under grade 1 protection;
3. Do not contain in the prescription of the eighteenth and nineteenth fear such as compatibility taboo;
4. In principle, prescription applicable scope does not include emergency and critical care, infectious diseases, and do not involve the special drugs such as pregnant women, infants and young children, the crowd; But is found to have curative effect, the outstanding features of prescriptions, discretion on, so as to adapt to clinical demand.
|
