Research On Legal Regulation Of Quality Assurance Of Traditional Chinese Medicines

In recent years,with the change of modern life style,habit disease and high incidence of lifestyle diseases and chronic diseases,people's health concept and modern medical model,Traditional Chinese medicine(TCM)plays an increasingly important role in the following aspects:(1)low price and convenient use;(2)Prevention First,treatment first,and treatment often.The advantages of traditional Chinese medicine in the treatment of "disease free" and low price and convenient use are increasingly prominent.At the same time,the national basic medical and health institutions fully implement the appropriate technology of traditional Chinese medicine,and the use of traditional Chinese medicine is more and more extensive.Compared with western medicine,traditional Chinese medicine has less toxic and side effects.It can treat local diseases and regulate the immune function of human body.It is gradually favored by all countries.However,in recent years,while traditional Chinese medicine is widely used,the unqualified rate of quality sampling of raw Chinese medicine in China is still high,facing the detention and return of raw Chinese medicine exports,even threatening the clinical efficacy of traditional Chinese medicine.The quality of traditional Chinese medicine has seriously restricted the healthy development of traditional Chinese medicine,hindered the modernization of traditional Chinese medicine and the pace to the international market.These problems in the field of quality supervision of traditional Chinese medicine not only threaten the inheritance and development of the cause of traditional Chinese medicine,but also expose the shortcomings of the current regulatory system of quality supervision of traditional Chinese medicine.Strengthening and improving the regulatory system of quality supervision of traditional Chinese medicine has become an urgent task.apan,which has more than90% of the market share of raw Chinese medicine in the world,uses 70% of the raw Chinese medicine from China.Because of its different regulatory system and implementation means for the quality supervision and assurance of raw Chinese medicine,it effectively protects the market order of raw Chinese medicine in Japan,and also makes a positive contribution to the promotion of national health and the reduction of medical insurance costs in Japan.We can learn from the Japanese laws and regulations on the quality assurance of Chinese herbal medicines,and put forward to strengthen and improve the quality assurance system of Chinese herbal medicines,so as to make suggestions for "healthy China".Traditional Chinese medicine belongs to medicine,its quality attribute is validity and safety.The effectiveness of traditional Chinese medicine depends on the genuine land and the content of effective ingredients,and the safety depends on the pollution situation of three residual substances.Therefore,this paper makes a comparative analysis of the origin,the content of effective ingredients and the pollution of three residual substances of traditional Chinese medicine between China and Japan,and draws lessons from the relevant laws and regulations of Japan on the origin,the content of effective ingredients and the pollution of three residual substances to develop and improve the quality assurance system of raw Chinese medicine.Japan has passed the pharmaceutical law,which has determined the legislative purpose as follows: This Law is established to ensure the quality,effectiveness and safety of pharmaceutical products,external products of the Ministry of medicine,cosmetics,medical devices and regenerative medical products,as well as to prevent the occurrence and expansion of the hazards of the above-mentioned products.As the legail standards for Kampo hebal medicines," Japanese Pharmacopoeia " and " Specifications medicine products out of Japanese Pharmacopoeia" on exogenous medicine clearly stipulate the origin of Kampo medicines." Independent standards for the manufacture and quality management of Chinese herbal preparations and crude drug preparations "," Rules for cultivation,harvesting and processing of medicinal plants".It is required that all raw Kampo medicines used by Kampo pharmaceutical enterprises shall conform to the designated place of origin,and other raw Kampo medicines shall not be used as medicine.According to the " Japanese Pharmacopoeia "," Specifications medicine products out of Japanese Pharmacopoeia" and the regulations on exogenous production,there are almost lower limit requirements for the content of the effective ingredients of all the Kampo herbal medicines in 294,some even have upper limit requirements,which are very strict for the content of the effective ingredients of the Kampo herbal medicines,and the industry benchmark and the enterprise independent benchmark are higher than the legal benchmark." The rules of cultivation,collection and processing of medicinal plants " has clear regulations on the cultivation of Kampo herbal medicines from seed,origin,soil,water source,chemical fertilizer,pesticide,collection,packaging,storage,etc.,which ensures the control of the source pollution of the three residual substances of Kampo herbal medicines." Japanese Pharmacopoeia " has strict limit requirements on almost all the three residual substances of Kampo herbal medicines.Japanese pharmaceutical law has passed laws and regulations in many dimensions,starting with raw materials of crude drugs,and finally forming preparations,carrying out quality control in the whole process,ensuring the content of effective ingredients,controlling residual pesticides,residual heavy metals and other toxic and harmful substances,ensuring the quality and efficacy of Kampo preparations,making Kampopreparations recognized by Japanese nationals and even some international markets.China's compulsory laws and regulations on "The quality assurance of raw Chinese medicine","drug management law","Chinese medicine law",Chinese Pharmacopoeia.Drug administration law and traditional Chinese medicine law only stipulate the connotation of the concept of "genuine place of origin" of traditional Chinese medicine raw materials,encourage and promote enterprises to use genuine traditional Chinese medicine raw materials,but the specific genuine place of origin of traditional Chinese medicine raw materials has not made any norms,designations and restrictions.The content of active ingredients in "Chinese Pharmacopoeia" and local standards is mostly lower than that in Japanese prescription.Some Chinese herbal medicines even have no regulations on the content of active ingredients.When testing the content of active ingredients,the reproducibility is less than that in Japanese prescription.Due to the gap issued by the State Drug Administration in 2002,due to the lack of compulsion and too general specification,it is difficult to implement the gap,which leads to the dilemma of no compulsion in the process of seed selection,planting(including soil,water source,chemical fertilizer,pesticide),harvesting,etc.Raw traditional Chinese medicine is in the current situation of pesticide residue,heavy metal residue and sulfur dioxide residue exceeding the standard from the source.As the legal standard for the quality inspection of raw traditional Chinese medicine,the "three residue" limit inspection only involves a few varieties of raw traditional Chinese medicine.Compared with the strict limit standard of "three residual substances" in almost all Kampo herbal medicines in Japan,the requirements of "three residual substances" in "Chinese Pharmacopoeia" are very loose;the quality problems such as unknown origin,unstable content of effective ingredients and "three residual substances" exceeding the standard are common in the Chinese herbal medicines which are finally used in the market.Compares and analyzes the laws and regulations on quality assurance of Chinese medicinal materials between China and Japan This paper summarizes the enlightenment significance of the French decrees on quality assurance of Chinese crude drugs in Japanese Pharmacopoeia regulations to the development and perfection of the system of Quality Assurance of Chinese crude drugs in China and the achievements of the perfection and development of the quality assurance regulations of Chinese crude drugs that can be used for reference by China Make the following practical suggestions.1.In the coming "Drug Administration Law","Chinese Medicine Law",the implementation of the rules,regulations and relevant supplementary provisions,from the legal and regulatory aspects of raw Chinese medicinal materials to make clear norms.2.During the revision of "Chinese Pharmacopoeia"(2020 edition)and later edition,the determination and identification methods of the effective components in Chinese crude drugs were revised with the Times,and the repeatability and scientificity of the detection methods were emphasized3.We should perfect and issue the "Good Agriculture Practice",that is,GAP standard of Chinese medicinal materials,control the three residues and other toxic and harmful substances from the source,and ensure the quality of Chinese medicinal materials.