Interpretation of traditional Chinese medicine (30)

Time: 2017-08-09

Source: Chinese medical journal

Article 30 the production of traditional Chinese medicine compound preparations that conform to the conditions stipulated by the state shall be used to provide only non-clinical safety research materials when applying for the approval of the drug. The specific administrative measures shall be formulated by the pharmaceutical supervisory and administrative department under the state council and the competent department of traditional Chinese medicine.

The ancient classical name mentioned in the preceding paragraph refers to the prescription of ancient Chinese medicine classics which are still widely used and effective and have distinct characteristics and advantages. The specific catalogue shall be formulated by the competent department of traditional Chinese medicine under the state council and the drug supervision and administration department.

This article is about the production of traditional Chinese medicine compound preparations that meet the requirements of the state.

Traditional Chinese medicine has a large number of prescription agents, many of which are still widely used in clinical practice, and these prescriptions have been proven to be effective through long-term clinical trials. If strict compliance with the general drug production rules to carry out clinical trial and approval, time-consuming, not conducive to mobilize the enterprise production enthusiasm. To this end, the specific provisions of this law, 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 regulation greatly simplifies the approval process for the production of such Chinese herbal compound preparations, which is conducive to the mobilization of the production initiative of the enterprises, and carries forward the ancient classical brand to the benefit of the general public.

This article is divided into two paragraphs. The first has been clear about 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. The second paragraph defines the ancient classic.

Pharmaceutical administration law stipulated in article 29, the development of new drugs, must, in accordance with the provisions stipulated by the pharmaceutical supervisory and administrative department under the state council truthfully submit the research method, quality index, pharmacology and toxicology test results and other relevant materials and samples, after approved by the pharmaceutical supervisory and administrative department under the state council, before conducting clinical trials. To complete the clinical trial and approve the new drug, it shall be approved by the drug regulatory authority under the state council and issued to the new drug certificate. Stipulated in article 30, drug non-clinical safety evaluation and research institutions and the clinical test units must respectively carry out pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test and the quality control standard. According to the provisions of the drug administration law, the new drug should be submitted to non-clinical safety research data and clinical trial report before approval.

Ancient classic square after years of use proved to be safe and effective, if in strict accordance with the pharmaceutical administration law of the clinical trials, the relevant provisions on the examination and approval, takes longer, supplementary provisions of the Chinese traditional medicine registration has been clear about the classic name just can leave out the clinical trial process. In the process of this law, formulate, in some places, experts, and pharmaceutical production enterprise, examination and approval shall be in conformity with Chinese medicine characteristics of traditional Chinese medicine (TCM), to produce qualified name comes from the ancient classical square compound preparations of Chinese medicine, should simplify examination and approval procedures, encourage enterprises to the development and utilization of traditional Chinese medicine resources. The legislative body has adopted this opinion and made special provisions.

Here the conditions stipulated in the "national", mainly refers to the state food and drug supervision bureau in 2008 of the supplementary provisions of the Chinese traditional medicine registration management issued to come from the ancient classic square set forth in the production of traditional Chinese medicine compound preparation conditions, including:

(1) the prescription contains no poisonous medicinal materials or compatibility taboos;

(2) there is legal standard for prescription of medicinal materials;

(3) the production process is basically the same as the traditional process;

(4) in accordance with ancient texts, the amount of daily consumption is comparable to that of ancient classics;

(5) the function is consistent with ancient medical records;

(6) the scope of application does not include critical illness, which does not involve pregnant women, infants and other special drug use groups. The prescription and the specific source of functional primary treatment should be indicated in the drug instruction manual of this kind of TCM compound preparation, and it is stated that the prescription has a long-term clinical application basis and is evaluated by non-clinical safety.

The provisions of this paragraph, shall be formulated by the pharmaceutical supervisory and administrative department under the state council together with the competent department of traditional Chinese medicine, namely by the state food and drug administration bureau together with the state administration of traditional Chinese medicine. The formulation of this specific management method is of great importance to the implementation of the provisions of this article. The relevant departments should cooperate actively to make relevant administrative measures available at an early date so as to ensure the implementation of the provisions of the law.

According to the provisions of the second paragraph, the ancient classical name refers to the prescription of ancient Chinese medicine classics which are still widely used and effective, with distinct characteristics and advantages. The "prescription" here refers to the prescription, whose specific catalogue is formulated by the department of traditional Chinese medicine under the state council in collaboration with the pharmaceutical supervisory and administrative department.

(excerpts from the interpretation of Chinese medicine law of the People's Republic of China, China democratic legal press)