subject: Chinese SFDA issued supplementary regulations Registration - registration of Chinese medicine, SFDA-pharmaceutical industry [print this page] Chinese SFDA issued supplementary regulations Registration - registration of Chinese medicine, SFDA-pharmaceutical industry
The first to reflect the characteristics of Chinese medicine, Chinese medicine research to follow the law, inherited traditions, encourage innovation, support the promotion of Chinese medicine and the development of national pharmaceutical industry, according to "Drug Registration", to introduce the supplementary provisions.
Second Chinese development of new drugs should comply with Chinese medicine theory, clinical practice-oriented basis, with clinical value, to ensure the safety of traditional Chinese medicine effective and stable quality, uniform, to protect the stability and resources of Chinese herbal medicines from the sustainable use and should concerned about the environmental and other factors. Involving endangered species of wild animals and plants shall comply with state regulations.
Third main medical treatment card is not approved in the state of proprietary Chinese medicines Functions and Indications The collection contains the drug, as "Drug Registration" fourth 15 paragraph (d) of the range.
Fourth application for registration of Chinese medicine should be clearly prescribed form, the original medicinal materials base, herbs and medicinal origin and Resources prior to treatment (including cooked), extraction, separation, purification, formulation and other processes, identify key process parameters.
Article should be in the traditional Chinese medicine theory of Traditional Chinese Medicine under the guidance of prescriptions, the prescription consists of Chinese Herbal Medicine (medicine), extract the effective part and effective components.
Such as Chinese herbal medicines with no statutory standards should be a separate establishment of quality standards; can not set standards for the effective parts and active ingredients, quality standards should be established independently and in accordance with the appropriate registration category to provide research data; Chinese herb extracts can be established The quality control standard, together with the quality standard, in preparation.
Article Summary of Traditional Chinese Medicine Compound addition to providing information, pharmaceutical research data, shall be in accordance with the provisions of Article VII, VIII and IX, on the different types of requests related to pharmacology and toxicology, and clinical trial data.
Article from ancient classics of Chinese medicine compound side, is still widely used and effective, with significant features and advantages of the Qing Dynasty and the Qing Dynasty before the prescriptions recorded in medical books.
(1) Chinese herbal compound preparation of such specific directory by the State Food and Drug Administration to assist the relevant departments to formulate and publish.
(B) meet the following conditions of such the traditional Chinese medicine, can only provide information on non-clinical safety studies, and direct reporting of production:
1. Prescription medicines or non-toxic incompatibility;
2. Yao Wei prescriptions are legal standards;
3. Production process is consistent with the traditional technique;
4. Route of administration consistent with the records of ancient medical books, daily volume and slices recorded in ancient medical books quite;
5. Attending functions written agreement with the ancient medical books;
6. Scope does not include critical illness, do not involve pregnant women, infants and other special medication groups.
(C) the class of drugs the traditional Chinese medicine prescription and instructions were to indicate the specific source and Indication shows that long-term clinical application of this basic recipe, and by the non-clinical safety evaluation.
