Anhui food and drug administration further strengthens the supervision of traditional Chinese medicine production

[policies and regulations of China Pharmaceutical network] on August 22, 2018, Anhui Provincial Drug Administration issued the "notice on Further Strengthening the supervision of traditional Chinese medicine production" (hereinafter referred to as the "notice") According to the notice, the national drug audit and Inspection Center recently supervised and inspected Xiaochaihu granules, and found that some production enterprises did not follow the legal prescription process, added Scutellaria extract in violation of regulations, and seriously violated the "drug production quality management specifications" After research, Anhui Provincial Food and Drug Administration decided to: urge Chinese medicine manufacturers to conduct a comprehensive self-examination of their products to ensure that their products are produced according to the legal prescription process; further strengthen the supervision and management of Chinese medicine production; and seriously deal with enterprises that violate the provisions of the "drug production quality management specifications" in accordance with the law In addition, for the Chinese patent medicine enterprises with different extraction workshops or shared extraction workshops, in the process of supervision and inspection, they should focus on whether they are included in the production and quality management system and manage the whole process of production to ensure the product quality It is worth noting that the notice mentions that all municipal bureaus will focus on: whether the production of traditional Chinese medicine is fed according to the process prescription, and whether to purchase traditional Chinese Medicine (stock in sheet or invoice) correspondence with the use and stock of Chinese herbal medicines; whether the quality of purchased Chinese herbal medicines and pieces of Chinese herbal medicines are inspected according to the legal standards of Chinese Pharmacopoeia (2015 version); whether they are produced according to the production process procedures, whether the process parameters between batches are relatively stable; whether the extraction process conforms to the production process of the produced Chinese herbal medicines, and whether they have been extracted Whether the process corresponds to the batch, quality control of intermediate products, extract yield, material balance, etc., to form a complete batch production record, and take effective quality control measures in storage, packaging, transportation, etc According to industry data, from 2013 to 2017, the qualified rate of Chinese herbal medicines and pieces of decoction has been increasing year by year and steadily improving, which fully reflects the achievements of strengthening the supervision of drug regulatory authorities at all levels in recent years However, compared with other drugs, the unqualified rate of traditional Chinese medicine and decoction pieces is still high Traditional Chinese medicine is the basic raw material for the production of Chinese herbal pieces and patent medicines Effective quality control in the whole process of the production of traditional Chinese medicine is an important measure to ensure the quality of traditional Chinese medicine is stable and controllable, as well as the safety and effectiveness of clinical use of traditional Chinese Medicine But for a long time, traditional Chinese medicine manufacturers do not produce according to the process prescription and do not manage according to the standard, which not only has a negative impact on consumers, but also seriously disrupts the stability of the whole traditional Chinese medicine industry In order to cope with the new situation of the development of traditional Chinese medicine industry, China has also tried to establish a complete set of supporting system to form a new "high pressure" situation for the supervision of traditional Chinese medicine, herbal pieces and proprietary Chinese medicine, and to strengthen the special inspection, flight inspection and other supervision means in various places, so as to standardize the market of traditional Chinese medicine Anhui Province issued a notice to further strengthen the supervision of traditional Chinese medicine production, which attaches great importance to the product quality of traditional Chinese medicine production enterprises, and will also restrict some enterprises' non-standard production behavior In this regard, the industry said that supervision is only a mandatory means, but more depends on the self-management and inspection of traditional Chinese medicine manufacturers "Only when enterprises do what they can, can the strengthening of supervision have its due effect."