Interpretation of Chinese medicine extraction and its regulatory measures

Recently, the State Food and Drug Administration issued the notice on strengthening the supervision and administration of extraction and extract in the production of traditional Chinese medicine, which requires strengthening the supervision of extraction and extract in the production of traditional Chinese medicine The relevant person in charge of the Department of pharmaceutical and chemical supervision of the State Administration has made an interpretation of the specific regulatory measures Reporter: how is Chinese herbal extract regulated in China? What are the current problems? Answer: the extraction and use of traditional Chinese medicine are the key links in the production and quality management of traditional Chinese medicine In order to strengthen the supervision of extraction and extraction of traditional Chinese medicine, the State Food and drug administration has successively issued relevant management documents, such as the notice on strengthening the supervision and management of pretreatment and extraction of traditional Chinese Medicine issued in March 2002 and the notice on regulating the production of traditional Chinese Medicine issued in July 2012 Notice on strict investigation and punishment of illegal activities in business order, allowing enterprises to extract traditional Chinese medicine by means of entrusted processing, and making it clear that pharmaceutical production enterprises must purchase and use traditional Chinese medicine extract for production from enterprises with pharmaceutical production qualification These documents regulate the production and use of Chinese herbal extracts, strengthen the responsibility of Chinese patent medicine manufacturers, and play a positive role in ensuring the quality of Chinese patent medicine Due to the complexity of the management of traditional Chinese medicine extraction and traditional Chinese medicine extract, there are many problems left over by history At present, there are some outstanding problems in the supervision of traditional Chinese medicine extraction and traditional Chinese medicine extract, which are mainly manifested as follows: first, some proprietary Chinese medicine enterprises do not have the extraction capacity, and it is difficult to guarantee the quality of drugs when they purchase illegal extraction drugs Second, the relevant management system is not perfect, especially in the aspects of corporate responsibility, regulatory responsibility and qualitative punishment, and the supervision and punishment are not enough Third, the properties of Chinese herbal extracts are not clear The existing drug regulatory laws and regulations do not define the regulatory attributes of traditional Chinese medicine extracts, resulting in unclear production and use of traditional Chinese medicine extracts, which are separated from the whole process of drug quality regulatory system Reporter: what measures will be taken by the State Administration to further strengthen the outstanding problems in the regulation of traditional Chinese medicine extraction and traditional Chinese medicine extraction? Answer: in order to prevent the problems existing in the extraction and extraction of traditional Chinese medicine from further worsening and damage the development of traditional Chinese medicine industry, the State Administration has taken active measures to eliminate the potential risks In July this year, the circular on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine (hereinafter referred to as the circular) was issued to strengthen the management requirements of pretreatment of traditional Chinese medicine and clarify the filing process of traditional Chinese medicine extraction Order and requirements, increase the punishment of illegal acts and other measures According to the requirements of the State Administration, pharmaceutical manufacturers must have the ability to extract traditional Chinese medicine in line with the variety and scale of production, and the entrusted processing of extraction of traditional Chinese medicine will be cancelled from January 1, 2016 In order to promote the scientific and reasonable allocation of market resources and prevent repeated construction, it is allowed to set up different workshops or enterprises with a certain holding relationship to share extraction workshops, but it is necessary to clarify the responsibilities of production enterprises and regulatory responsibilities In addition, in order to promote the filing management of traditional Chinese medicine extracts, the General Administration has stipulated the detailed rules for the implementation of the filing management of traditional Chinese medicine extracts, clarified the filing scope, procedures and basic requirements, and strengthened the quality responsibility of the enterprises using traditional Chinese medicine extracts, i.e the relevant Chinese patent medicine manufacturers At the same time, in order to unify the supervision, it is clear that the approval number management will not be carried out for the Chinese herbal extracts that have been put on record According to the notice, the pretreatment of traditional Chinese medicine is an important process in the production of traditional Chinese medicine The enterprises producing traditional Chinese medicine and the enterprises producing extracts of traditional Chinese medicine shall have the facilities and equipment for the pretreatment of traditional Chinese medicine corresponding to the varieties they produce, formulate the corresponding pretreatment process procedures, and process and process the traditional Chinese medicine materials If the raw materials of Chinese herbal pieces are purchased for production, they must be purchased from the production and operation enterprise of Chinese herbal pieces with legal qualification In order to enhance the binding force and operability, the General Administration of food and drug administration requires that all food and drug regulatory departments strengthen their daily supervision and management, investigate and punish the illegal behaviors in accordance with the law, and clarify the qualitative punishment standards for investigation and punishment; for different illegal behaviors, punish according to the GMP requirements of fake drugs or illegal drugs respectively.