Yunnan Provincial Food and Drug Administration issued a plan for the promotion of processing Chinese medicinal materials at the origin

On August 16, the Yunnan Provincial Food and Drug Administration issued a notice on the promotion plan for processing Chinese medicinal materials at the origin of Yunnan Province

The original text is as follows:

Notice of the Yunnan Provincial Drug Administration on Printing and Distributing the Promoting Plan for Processing Chinese Medicinal Materials in the Origin of Yunnan Province

Yunyao Jiansheng (2021) No.

Relevant departments and institutions of the provincial bureau, and relevant drug manufacturers:

In order to implement the spirit of the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine" and the "Notice on Several Policies and Measures to Accelerate the Development of Traditional Chinese Medicine" issued by the General Office of the State Council, in accordance with the The Reply to the Issues Concerning the Processing of Chinese Medicinal Materials (Cut Freshly) (Yao Jian Zong Yao Guan Han [2021] No.

Yunnan Provincial Drug Administration

August 10, 2021

(This piece is publicly released)

Yunnan Provincial Drug Administration

Promoting plan for processing Chinese medicinal materials at the origin

In accordance with the "Response Letter of the Comprehensive Department of the State Drug Administration on the Issues Concerning the Procurement of Traditional Chinese Medicine Decoction Pieces Manufacturers' Procurement of Chinese Medicinal Materials" (Yao Jian Zong Yao Guan Han [2021] No.

1.

Adhere to the concept of upright and innovative development of traditional Chinese medicine, implement the relevant work requirements of the State Food and Drug Administration, take the standard of fresh processing of Chinese medicinal materials as a starting point, and encourage pharmaceutical manufacturers in the province that have the ability to process fresh Chinese medicinal materials to implement quality management systems.

2.

(1) Develop a catalogue of Chinese medicinal materials that are processed in Yunnan Province (cut when they are fresh)

Based on the actual processing conditions of Yunnan traditional Chinese medicinal materials, and on the basis of fully demonstrating the necessity and feasibility of processing when fresh, the "Catalogue of Yunnan Province Processing (Prepared by Fresh Cut) Medicinal Materials" (hereinafter referred to as "Catalog") is released in batches.

Based on the actual work, the Yunnan Province Producing Area Processing (Cut Fresh) Expert Forum on July 19, 2021 preliminarily determined the first draft of the first batch of "Catalogue", and related companies are responsible for the development of the varieties in the first batch of the first draft of the "Catalogue" Technical research (see appendix), provide relevant research materials, after expert argumentation, form the first batch of "Catalogues" in Yunnan Province and publicly solicit opinions.

(2) Formulating the guiding principles for processing in Yunnan Province (cutting beforehand)

The Pharmaceutical Production Division of the Provincial Administration shall, on the basis of full investigations, compile the processing guidelines for processing at the origin of Yunnan Province (prepared for the fresh cut) processing.

(3) Issuing the notice on the pilot work of Yunnan Province's production area processing (prepared and cut)

1.

2.

(1) Strictly implement the relevant requirements of the "Response Letter of the Comprehensive Department of the State Drug Administration on the Issues Concerning the Procurement of Traditional Chinese Medicine Decoction Pieces Manufacturers' Procurement of Chinese Medicinal Materials" (Yao Jian Zong Yao Guan Han [2021] No.

(2) It is clear that the origin and processing belong to the category of the source of Chinese medicinal materials

(3) Fresh-cutting is one of the methods of processing at the place of production.

(4) Based on the idea of ​​fully implementing the main responsibility for quality of pharmaceutical manufacturers, standardize the behavior of Chinese herbal medicine manufacturers in our province to purchase Chinese herbal medicines from the origin (cutting them while they are fresh), including how to extend the quality management system, the demonstration text of the procurement contract and the quality agreement , Regarding how to review the production area processing enterprises, etc.

(5) The production line or workshop is included in the management of the drug production license, and the production line or production workshop that is freshly cut will be published on the provincial bureau website in accordance with the law
.
According to the requirements of the national bureau documents, within the framework of the regulations, encourage pharmaceutical production enterprises in Yunnan Province with production areas processing and production conditions and strong quality management capabilities to carry out production area processing, and strengthen the driving and demonstration effect of standardized production area processing in our province (cutting fresh) , Helping leading enterprises to enlarge and strengthen the processing industry of the origin is conducive to creating large varieties of processing in the origin with Yunnan characteristics, driving the development of the cultivation of Chinese medicinal materials and the industry of traditional Chinese medicine decoctions in our province, and forming the highlights and characteristics of processing in our province
.

(6) It is clear that the fresh-cut Chinese medicinal materials should meet the legal standards (except for traits), and the processing enterprises in the place of origin shall formulate the processing standards and procedures for fresh-cut Chinese medicinal materials as required
.

(7) For the Chinese medicine decoction pieces companies that purchase fresh-cut products from the place of origin, clearly put forward the requirements for establishing a full-process information traceability system
.

(8) It is clear that fresh-cut pharmaceutical materials should have standardized packaging and labels, and attached quality-qualified labels
.
The packaging materials directly in contact with medicinal materials meet at least the food packaging material standards.
The label content should include: product name, specification, quantity, place of origin (at least to the county, district, and city), harvest date, production batch number, storage, shelf life, and company name and so on
.
According to the product characteristics, packaging form, test results, etc.
of the fresh-cut medicinal materials, the storage conditions can be indicated, and the quality guarantee period can be formulated.
Fresh-cut medicinal materials that exceed the quality guarantee period shall not be sold
.

(9) Clarify the prohibition clauses in the process of processing (cutting while fresh) medicinal materials in the province's traditional Chinese medicine decoction pieces enterprises
.

3.
The "Notice" will be issued and implemented before September 30, 2021
.
The first batch of "Catalog", "The Guiding Principles for Processing at the Origin of Yunnan Province (Cut Fresh)", the demonstration texts of the quality agreement between the production enterprises of traditional Chinese medicine in Yunnan Province and the processing (cut fresh) enterprises in Yunnan Province were issued and implemented together
.

3.
Work requirements

(1) Origin processing is an important measure to help the development of the cloud medicine industry.
The policy formulation and introduction process should strengthen research, fully demonstrate, make the whole process open, and administer according to law, strengthen publicity, accept the supervision of the public and public opinion, and ensure the fairness and fairness of the policy Sex and legality
.

(2) The promulgation of policies related to the processing of Chinese medicinal materials at the place of production (cutting them while they are fresh) is related to the high-quality development of the province’s traditional Chinese medicine industry.
It is a key task in 2021.
Units are requested to attach great importance to them, cooperate with them, and improve work efficiency.
Working together, we must promptly summarize and solve the difficulties and problems encountered in the work; pay attention to the role of industry associations and experts and scholars, guide industry self-discipline and corporate integrity, and accelerate the promotion of related work
.

(3) All units shall increase the investigation and handling of cases in accordance with the relevant requirements of the special action on the quality and safety of Chinese herbal medicine decoction pieces
.
Resolutely ban illegal dens, black factories, and black workshops that illegally produce Chinese herbal medicines and Chinese herbal medicines, and severely crack down on illegal processing and direct subcontracting of semi-finished products.
(System) The introduction and implementation of policies related to Chinese medicinal materials create a good scope of work
.

Attachment: The division of labor for the research on the catalogue of the first batch of processed Chinese medicinal materials in Yunnan Province.