Legal thinking on the status quo and supervision of Chinese medicine extract industry

With the continuous development and deepening of medical economy, traditional medicine plays an increasingly important role Due to the large toxic and side effects of chemical drugs, which are easy to produce drug resistance, the research and development of new pure compounds is difficult, long cycle and high cost Therefore, traditional Chinese medicine extracts (raw materials for the production of traditional Chinese medicine made of pure herbs or processed products by extraction, clarification, filtration, evaporation and other methods) emerge with its unique advantages, and gradually burst out huge potential At one time, the export ratio exceeded that of traditional Chinese medicine and herbal pieces However, at present, there is still a lack of necessary norms in the legal level in the research and development, production and circulation of traditional Chinese medicine extracts There are many kinds of traditional Chinese medicine extraction products, specifications are miscellaneous, lack of national standards or industry standards, production enterprises are uneven, circulation order is chaotic and other problems have been the bottleneck restricting the development of traditional Chinese medicine extraction industry, which needs to be regulated by law Current situation of traditional Chinese medicine extraction industry Traditional Chinese medicine extract is a new type of traditional Chinese medicine product, which integrates modern pharmaceutical new technology It is a raw material product for Chinese patent medicine production, which is extracted and purified by the methods of extraction, clarification, filtration, evaporation and so on It has a broad market space, and is widely used in many fields such as medicine, food, health care products, cosmetics, etc., thus driving a big Batch related industries At present, there are also plant chemical enterprises (referred to as plant chemical enterprises), traditional Chinese medicine extraction and purification enterprises (referred to as purification enterprises), traditional Chinese medicine extraction enterprises, plant extraction enterprises and so on According to the mode of production, it can be roughly divided into the following five categories: first, traditional export extract manufacturers By extracting effective ingredients from natural plants, we can provide raw materials for food, cosmetics and other industries Second, the extraction workshop set up by the traditional Chinese medicine production enterprise Due to their own production needs, traditional Chinese medicine production enterprises set up a special workshop for extracting traditional Chinese medicine Such enterprises have passed GMP certification and their production is relatively standardized Third, the production enterprises specialized in the extraction of traditional Chinese medicine By virtue of its industry advantages, GMP certified professional extraction enterprises undertake all kinds of entrusted processing contracts to provide raw materials for pharmaceutical manufacturers Fourth, the traditional Chinese medicine extraction workshop established by the food, health care products and cosmetics manufacturers Fifth, comprehensive plant extraction enterprise These enterprises integrate traditional plant extraction and traditional Chinese medicine extraction industries, most of which are transformed from food processing enterprises As most of the traditional Chinese medicine comes from natural plants, these enterprises evade supervision in the name of pure natural plant extraction, but actually engage in the extraction and processing of traditional Chinese medicine and the pretreatment of traditional Chinese medicine Some enterprises cover up their extraction of traditional Chinese medicine under the guise of "health license" and processing food raw materials Such enterprises are the core and focus of current supervision Current legislative situation For the positioning and qualitative of Chinese herbal extracts, there is no clear stipulation in the drug administration law and its implementing regulations Some people think that Chinese herbal extracts should be attributed to the category of "API" in the drug concept, but the author thinks that "API" in the drug administration law specifically refers to the chemical API, not the pharmaceutical raw materials of Chinese herbal preparations 1 The extract of traditional Chinese medicine shall be supervised according to the drug According to the principle of naming the generic names of Chinese medicines, "Chinese herbal extracts refer to the raw materials for the production of Chinese patent medicines that are extracted and purified by appropriate methods from pure medicinal materials or processed products ① The name of traditional Chinese medicine extract is generally composed of the name of traditional Chinese medicine and extract ② If it has been purified to a certain category of ingredients, it should be named after the name of the medicinal material plus the category of ingredients, and if necessary, it can add a byname " Article 45 of the measures for the administration of drug registration stipulates: "the State Food and drug administration may apply for special examination and approval for the following applications: (1) the effective ingredients and preparations extracted from plants, animals, minerals and other substances that are not marketed in China, and the newly discovered medicinal materials and preparations For a drug conforming to the provisions of the preceding paragraph, the applicant may apply for special examination and approval in the process of drug registration The drug evaluation center of the State Food and drug administration shall organize an expert meeting to discuss and determine whether to implement special examination and approval Specific measures for special examination and approval shall be formulated separately " Article 5 of the supplementary provisions on the administration of the registration of traditional Chinese medicine stipulates: "the compound preparation of traditional Chinese medicine shall be formulated under the guidance of the theory of traditional Chinese medicine, and its prescription composition includes Chinese herbal pieces (herbs), extracts, effective parts and effective ingredients A controlled quality standard shall be established for the extract of traditional Chinese medicine and attached to the quality standard of the preparation " It can be seen from the above regulatory documents that the extract of traditional Chinese medicine is the pharmaceutical raw material made from the extracted, concentrated, purified [FS: PAGE] technology of traditional Chinese medicine or processed products, which belongs to the pharmaceutical component and should be managed in accordance with the relevant provisions of the state on drug supervision 2 The medicinal extracts not marketed in China are new drugs In the notice on promoting the implementation of the quality management standard for non clinical drug research (gsyj [2006] No 587), it is pointed out that "in order to further promote the implementation of GLP in non clinical drug research, improve the level of drug research from the source and ensure the quality of drug research, it is determined that since January 1, 2007, the chemical APIs, their preparations and biological systems that have not been listed and sold in China have not been produced Products; the effective components, parts and preparations extracted from plants, animals, minerals and other substances that are not marketed in China, and the effective components and preparations extracted from traditional Chinese medicine and natural medicine; the non clinical safety evaluation research of new drugs for traditional Chinese medicine injection must be carried out in a laboratory certified by GLP and meeting the requirements of GLP Otherwise, the drug registration application will not be accepted The non clinical safety evaluation study of the above drugs has been carried out before January 2007, and the application materials for drug registration can be accepted " This shows that the state has extended the concept of "new drugs refer to drugs that have not been marketed in China" in the regulations for the implementation of the drug administration law, which should also include the effective ingredients, effective parts and preparations extracted from plants, animals, minerals and other substances that have not been marketed in China, and the effective ingredients and preparations extracted from traditional Chinese medicine and natural drugs, i.e traditional Chinese medicine Extract 3 The entrusted production and processing of Chinese herbal extracts must meet the legal requirements In the notice on strengthening the supervision and management of pretreatment and extraction of traditional Chinese Medicine issued by the State Administration on March 16, 2003, it is pointed out that "first, pretreatment and extraction of traditional Chinese medicine is an important process in the production of traditional Chinese medicine, and also a key link to ensure the quality of traditional Chinese medicine In the process of GMP transformation, each TCM manufacturer shall reasonably set up TCM pretreatment and extraction workshop according to the requirements of production process 4、 The drug regulatory bureaus of all provinces, autonomous regions and municipalities directly under the central government shall, in accordance with the relevant provisions of the drug administration law, strengthen the supervision and management of the extraction of traditional Chinese medicine, and shall not issue a drug production license separately to any enterprise that does not fall under the control of the national drug standards 5、 With the approval of the drug regulatory bureau of the province, autonomous region and municipality directly under the central government, the enterprise may entrust other Chinese medicine enterprises that have obtained the GMP certificate to extract and process Chinese medicine The entrusting party shall establish controllable quality standards such as the content determination or fingerprint of the extract, and provide necessary technical documents During the entrusted processing, the entrusting party shall assign quality and technical personnel to carry out quality monitoring and technical guidance in the whole production process, so as to ensure the quality of Chinese herbal extracts and final products At the same time, the entrusting party shall keep the original batch production records extracted from traditional Chinese medicine to ensure the traceability of the quality of the final products The legal responsibility for drug quality shall be borne by the entrusting party " This shows that the production and processing of Chinese herbal extracts must meet the requirements of the drug administration law and the drug production quality management standard 4 Some Chinese herbal extracts have been included in the national standardized management At present, some Chinese herbal extracts have obtained the national drug approval number, which indicates that the standardized development of Chinese herbal extraction industry has taken a gratifying step However, most of the traditional Chinese medicine extracts are still out of the standard, such as Hypericum perforatum extract, Taxus extract, Gynostemma pentaphyllum extract and so on Due to the lack of standard regulation, the production and circulation are not standardized, so it is difficult to get rapid development, which also brings inconvenience to the supervision work It can be seen from the above analysis that, as an important process of traditional Chinese medicine production, traditional Chinese medicine extraction is a necessary link to ensure the quality of traditional Chinese medicine preparation; as a medicinal raw material of traditional Chinese medicine preparation, it is also necessary to establish standards and strengthen management as soon as possible, so as to gradually integrate with international standards, so that traditional medicine can completely break through trade barriers and go abroad For this reason, the author suggests: first, in the concept of drugs, Chinese herbal extracts should be clear It is suggested that Chinese herbal extracts should be included in the extension of the concept of drugs when the drug administration law is revised again 2 Standardized management of Chinese herbal extracts It is suggested that the compulsory declaration and registration system should be implemented for the production and processing of Chinese herbal extracts For the extraction of effective ingredients, effective parts and preparations from plants, animals, minerals and other substances, and the extraction of effective ingredients from Chinese herbal medicines and natural medicines, the national drug approval number must be obtained in accordance with the law Otherwise, according to Article 48, paragraph 3, item (2), of the drug administration law, "according to this Law Those who have to be approved but not approved for production or import, or those who have to be inspected but not inspected in accordance with this law, i.e., [FS: PAGE] for sale, shall be punished as producing fake drugs At the same time, the National Bureau shall formulate the quality management specification for extraction of traditional Chinese medicine and establish a standardized production quality control system All extraction enterprises of traditional Chinese medicine must pass the quality system certification of the quality management specification for extraction of traditional Chinese medicine on the basis of obtaining the drug production license according to law Any enterprise that fails to pass the certification shall be punished in accordance with the provisions of Article 73 of the drug administration law on unlicensed production III no matter the exclusive enterprise or the concurrent enterprise engaged in the extraction of traditional Chinese medicine, as long as the effective ingredients, effective parts and preparations are extracted from plants, animals, minerals and other substances, and the effective ingredients are extracted from traditional Chinese medicine and natural drugs, they shall be treated according to the extraction enterprise of traditional Chinese medicine and meet the corresponding management requirements IV the extraction workshop set up by the food, health care products and cosmetics enterprises must pass the quality system certification of the quality management standard for extraction and production of traditional Chinese medicine, otherwise they shall not be engaged in production and processing 5 Enterprises engaged in the sale of Chinese herbal extracts must obtain a drug distribution license in accordance with the law, or they shall be investigated and punished as unlicensed ones The operating enterprise shall not operate the products of the enterprise that fail to pass the quality system certification of the standard for the quality management of extraction and production of traditional Chinese medicine; it shall not operate the extracts of traditional Chinese medicine without the approval number, otherwise, it shall be punished as selling fake drugs Vi when the products are cleared, the approval number of Chinese herbal extracts and the quality system certification mark of the quality management standard for Chinese herbal extract production shall be taken as the important basis for customs declaration; otherwise, they shall not be exported.