Reply of the general affairs department of the State Food and Drug Administration on issues related

Yjzygh [2021] No. 367
Anhui and Gansu Drug Administration:
Anhui Provincial Drug Administration's request for instructions on allowing Chinese Herbal Slice manufacturers to purchase fresh cut products from the origin of Chinese herbal medicines in Linquan county (wyjzh [2020] No. 28) and Gansu Provincial Drug Administration's request for instructions on allowing Chinese Herbal Slice manufacturers to purchase processed slice products from the origin of Chinese herbal medicines in Dazhong real estate in Gansu Province (gyjf [2020] No. 201) Received. *** The relevant opinions are hereby written as follows:
1、 Processing in the producing area belongs to the source of Chinese medicinal materials. Cutting while fresh is one of the methods of processing in the producing area. It cuts the collected fresh Chinese medicinal materials into pieces, blocks, segments and valves according to the traditional processing methods. Although the shape of Chinese medicinal materials is changed, the nature of Chinese medicinal materials is not changed, and the processing links of drying, infiltration, cutting and re drying of Chinese medicinal materials are reduced, To a certain extent, it is conducive to ensuring the quality of traditional Chinese medicine. The manufacturer of Chinese herbal pieces can purchase the fresh cut Chinese herbal medicines produced by the origin processing enterprise with a sound quality management system (hereinafter referred to as fresh cut herbal medicines) for the production of Chinese herbal pieces.
2、 A manufacturer of Chinese Herbal Pieces purchasing fresh cut medicinal materials shall extend its quality management system to the planting, collection and processing of the medicinal materials, sign a purchase contract and quality agreement with the processing enterprise in the place of origin and keep them properly, and shall strictly review the quality management system of the processing enterprise in the place of origin, which shall at least include the following contents:
（1） A processing enterprise at the place of origin shall have professional and technical personnel and processing, drying, packaging, warehousing and other facilities and equipment commensurate with its processing scale, and shall have the ability to cooperate with the production enterprise of traditional Chinese medicine pieces to implement the requirements of drug quality management.
（2） Fresh cut medicinal materials shall be listed in the catalogue of fresh cut medicinal materials published by the local provincial drug regulatory department, and their basic source and quality (except form) shall comply with the corresponding provisions in the national drug standards such as the Chinese pharmacopoeia or the processing specifications of traditional Chinese medicine prepared in provinces (autonomous regions and municipalities directly under the central government) The processing shall meet the requirements of the standard for the production quality management of traditional Chinese medicine.
（3） Processing enterprises at the place of origin shall formulate standards and procedures for cutting and processing specific varieties in accordance with the guiding principles for cutting and processing while fresh published by the local provincial drug regulatory department and in combination with the characteristics and reality of fresh cut medicinal materials. The cutting and processing of fresh cut medicinal materials shall be carried out in accordance with the relevant provisions of the code for the quality management of drug production and its appendix to decoction pieces of traditional Chinese medicine (hereinafter referred to as the GMP of decoction pieces of traditional Chinese Medicine), with complete and accurate batch production records, and the cutting and processing procedures shall be supported by traditional experience or research verification data.
（4） Fresh cut medicinal materials shall have standardized packaging and labels, and be attached with quality qualification marks. The packaging materials in direct contact with medicinal materials shall meet the medicinal requirements, and the label contents shall include: product name, specification, quantity, place of origin, collection date, production batch number, storage, shelf life, enterprise name, etc.
（5） Processing enterprises in producing areas shall establish a complete quality traceability system for traditional Chinese medicine, which can ensure the traceability of the whole process of traditional Chinese medicine cultivation, collection, processing, drying, packaging, storage and sales.
3、 The manufacturer of prepared pieces of traditional Chinese medicine shall be responsible for the quality management of the purchased fresh cut medicinal materials. The fresh cut medicinal materials shall be warehoused for acceptance. The production and processing such as purification and processing shall be carried out in accordance with the GMP requirements of prepared pieces of traditional Chinese medicine and the national drug standards or the processing specifications of prepared pieces of traditional Chinese medicine of provinces (autonomous regions and municipalities directly under the central government), and can be sold only after passing the inspection. On the basis of the quality traceability of the origin processing enterprises, the production enterprises of Chinese herbal pieces shall further improve the information traceability system to ensure that the purchased fresh cut medicinal materials can be traced in the whole process of planting, harvesting, processing, drying, packaging, warehousing and processing and sales of Chinese herbal pieces.
4、 The manufacturer of Chinese herbal pieces shall not purchase fresh cut medicinal materials from various Chinese herbal medicine markets or individuals for the production of Chinese herbal pieces; It is also not allowed to purchase fresh cut medicinal materials for the production of prepared pieces of traditional Chinese medicine from processing enterprises in places of origin with imperfect quality management system or without quality management system; The purchased fresh cut medicinal materials shall not be directly packaged and sold as pieces of traditional Chinese medicine.
5、 In combination with the actual production of traditional Chinese medicine in our province, on the basis of organizing and demonstrating the rationality and necessity of fresh cut medicine, following the traditional processing habits, and in accordance with the overall requirements of ensuring quality, facilitating storage and convenient transportation, your bureau is requested to study and formulate the catalogue of varieties of fresh cut medicine and the guiding principles for processing while fresh cut. The Chinese medicinal materials listed in the catalogue shall be the dominant varieties with large-scale planting and origin processing traditions in a certain area of the province, which are suitable for cutting while fresh, and there are basis to support that the cutting while fresh has no adverse impact on the quality.
The catalogue of fresh cut medicinal materials, the guiding principles for processing while fresh cut and the key process of its formulation shall be made public in a timely manner through official websites and accept social supervision.
6、 Your bureau is requested to supervise and urge the production enterprises of traditional Chinese medicine decoction pieces within the administrative region to implement the main responsibility of quality management, strengthen the audit of the quality management system of the processing enterprises in the origin, earnestly do a good job in the quality uation and monitoring of fresh cut medicinal materials, and strengthen the management of standardized planting, harvesting, processing, drying, packaging, warehousing and other links of traditional Chinese medicine.
7、 Your bureau is requested to establish and improve a working mechanism in which local governments take overall responsibility and agricultural, rural, market supervision, health and other departments take their own responsibilities in combination with the actual demand of the origin of traditional Chinese medicine and in cooperation with the people's government at the county level of the city where the origin is located. Assist the people's government at the county level of the city of origin and relevant institutions to formulate a scientific development plan for the traditional Chinese medicine industry, promote the standardized planting of traditional Chinese medicine, establish a selection and exit mechanism for origin processing enterprises, strengthen the supervision of origin processing enterprises, establish an information platform for tracing traditional Chinese medicine, and collect key information such as the source of seeds and seedlings, planting area, pesticide use records, output and sales quantity, Provide information services for the planting, harvesting and processing of traditional Chinese medicine, and share them with local drug regulatory departments and relevant traditional Chinese medicine decoction pieces manufacturers.
8、 Your bureau is requested to strengthen the supervision and management of relevant traditional Chinese medicine decoction pieces production enterprises in this province, and strictly prevent unqualified products, or even fake and shoddy products from flowing into pharmaceutical channels. If it is found that there are hidden dangers of drug quality and safety, it shall take risk control measures such as suspending production and sales in accordance with laws and regulations; Those who find illegal acts such as the production and sale of fake and inferior drugs shall be severely investigated and punished according to law and regulations; If it is found that there are major problems in the procurement of fresh cut medicinal materials by traditional Chinese medicine manufacturers or there are major improvement suggestions, please report to the State Food and Drug Administration in time.
We hereby reply.
Comprehensive Department of State Food and Drug Administration
June 18, 2021