GAP restarts!

Representative of the "Two Sessions": Planting medicinal materials with reference to the crop model is the greatest tragedy of traditional Chinese medicine

The 2022 version of GAP: highlights the management, prevention, control, and construction of key links, and has detailed regulations on authentic regions, germplasm and seedlings, use of agricultural and veterinary drugs, and harvesting

Professor Liu: The production capacity of authentic medicinal materials is not the key.

Experts in the Chinese medicine industry: Ensuring the consistency and traceability of each batch of Chinese herbal medicines will become a must for leading Chinese medicine companies in China, and the market competitiveness of "Dao-produced regions + whole-process traceable pieces" will be further strengthened

(Reporter Li Yao from this newspaper) In January 2022, the "14th Five-Year Plan" National Planting Industry Development Plan issued by the Ministry of Agriculture and Rural Affairs put forward a goal: by 2025, the area of ​​traditional Chinese medicinal materials in the country will be stabilized at about 45 million mu, The area of ​​authentic medicinal materials accounts for more than 50% of the total area

After being harvested and processed, these medicinal crops have formed a market for Chinese herbal decoction pieces with a GDP of over 200 billion yuan

Tens of millions of acres grow in different regions, with different climates, soils, and crops grown by different farmers.

On March 17, the State Food and Drug Administration, the Ministry of Agriculture and Rural Affairs, the State Forestry and Grass Administration, and the State Administration of Traditional Chinese Medicine jointly issued the "Quality Management Practice for Chinese Medicinal Materials" (referred to as "Chinese Medicinal Materials GAP")

Chinese herbal medicines are managed from the source

Chinese herbal medicines are the source of the Chinese medicine industry and the material basis for the development of Chinese medicine

"Domestic Chinese herbal medicines are mostly grown by individual farmers, and some varieties may be traded in various forms such as agricultural products, food, medicinal materials, etc.

"It is the biggest sadness of traditional Chinese medicine to refer to the crop model to plant medicinal materials
.
" During the "two sessions" this year, many deputies to the National People's Congress and members of the Chinese People's Political Consultative Conference put forward suggestions on improving the quality of traditional Chinese medicinal materials
.
Zhang Boli, an academician of the Chinese Academy of Engineering, put forward a suggestion during the "two sessions" that a regional brand of authentic medicinal materials should be built, the whole process of high-quality medicinal materials should be traced, and high-quality Chinese medicinal materials should be promoted with high quality and good price, and high quality should be given priority
.

In 2002, the former State Drug Administration issued and implemented the "Quality Management Practice for the Production of Chinese Medicinal Materials (Trial)" to standardize the production of Chinese medicinal materials and promote the standardization and modernization of Chinese medicinal materials
.
In 2016, according to the “Decision on Cancellation of 13 Administrative Licensing Items of State Council Departments” (Guo Fa [2016] No.
10) issued by the State Council, the former State Food and Drug Administration announced the cancellation of the Good Manufacturing Practice (GAP) certification for Chinese medicinal materials
.
In 2017 and 2018, the State Drug Administration publicly solicited opinions on the newly revised GAP for Chinese herbal medicines
.

"From the perspective of the enterprise, the top-level design of traditional Chinese medicine production specifications has basically been completed, and the traditional Chinese medicine industry has entered an era of comprehensive regulation
.
" said Chen Zhouquan, technical director of traditional Chinese medicine of Sichuan Kelun Pharmaceutical
.

It is reported that compared with the 2002 version of the Chinese herbal medicine GAP, the 2022 version of the Chinese herbal medicine GAP has added 87 items, highlighting the management, prevention, control, and construction of key links.
etc.
have detailed regulations
.
For example, in order to ensure the purity of Chinese medicinal material germplasm, reduce the risks brought by uncertain germplasm, and take into account the actual production situation, the new version of Chinese medicinal material GAP encourages enterprises to carry out the selection and breeding of fine Chinese medicinal material, but the polyploid generated by manual intervention is prohibited.
Or haploid varieties, interspecific hybrids and transgenic varieties
.
In addition, if it is necessary to use non-traditionally used interspecific grafting materials, mutagenized varieties (including physical, chemical, space mutagenesis, etc.
) and other biotechnological breeding varieties, the enterprise should provide sufficient risk assessment and experimental data to prove new The varieties are safe, effective and quality controllable
.

In terms of pesticide use, the new version of GAP requires enterprises to clarify the requirements for pesticide use according to the actual situation of the Chinese medicinal materials planted and the management model of the base, and give priority to the use of high-efficiency and low-toxic biological pesticides; minimize or avoid the use of herbicides, pesticides and Chemical pesticides such as fungicides
.
Prohibited use: The use of highly toxic, highly toxic, and high-residue pesticides prohibited by the agricultural and rural administrative department of the State Council, as well as other pesticides restricted to use in Chinese medicinal materials
.
It is forbidden to use growth regulators such as zhuanggenling and expandin to regulate the growth of harvested organs of Chinese herbal medicines
.

The 2022 version of the GAP for Chinese medicinal materials also requires: Chinese medicinal materials production bases should generally be located in authentic areas, and in non-authentic areas, sufficient literature or scientific data should be provided to prove their suitability
.

There are voices questioning whether the production base of Chinese medicinal materials is too narrow to be limited to the authentic medicinal material production area? Can the authentic medicinal material producing areas meet the needs of the traditional Chinese medicine industry? According to a professor surnamed Liu, at present, there are more than 600 kinds of traditional Chinese medicinal materials commonly used in China, of which more than 300 kinds have been cultivated artificially.
It is a superior production area of ​​authentic medicinal materials with good quality and high reputation
.

In 2018, the Ministry of Agriculture and Rural Affairs, together with the State Drug Administration and the State Administration of Traditional Chinese Medicine, compiled the "National Construction Plan for Authentic Medicinal Materials Production Bases (2018-2025), which clearly states that from 2018 to 2025, the production of authentic medicinal materials will be built nationwide every year.
The base is more than 3 million mu
.
By 2025, a total area of ​​more than 25 million mu of authentic medicinal material production bases will be built nationwide, and a quality traceability system, production and sales information monitoring system and circulation system covering major authentic medicinal material production areas in the country will be formed
.

 "The production capacity of authentic medicinal materials is not the key.
The key is whether the quality and price can be achieved after the standard is raised
.
" Professor Liu said
.

Whole process traceability of decoction pieces or rapid replacement

In 2019, the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine" clearly stated that, with the supervision of traditional Chinese medicine pieces as the starting point, extending upstream and downstream, implementing the main responsibility of traditional Chinese medicine production enterprises, establishing a multi-department collaborative supervision mechanism, and exploring the establishment of traditional Chinese medicinal materials , Traditional Chinese medicine decoction pieces, Chinese patent medicine production and circulation using the whole process of traceability system, in about 5 years, gradually realize the source of key varieties of traditional Chinese medicine can be traced, the whereabouts can be traced, and the responsibility can be investigated
.

The 2022 version of the GAP for Chinese medicinal materials further specifies that enterprises should establish a quality traceability system for the production of Chinese medicinal materials to ensure the entire process from production plots, seeds and seedlings or other reproductive materials, planting and breeding, harvesting, processing, packaging, storage and transportation to delivery at the place of origin Key links can be traced; enterprises are encouraged to use modern information technology to build a traceability system
.

At the local practice level, some regions have encouraged the clinical use of whole-process traceable decoction pieces through policies such as bidding procurement, high-quality and competitive prices
.

On March 3, the Sanming Purchasing Alliance (National) Inter-Provincial Traditional Chinese Medicine (Material) Purchasing Alliance issued a notice to carry out the procurement of some TCM decoction pieces across regions in the alliance provinces (autonomous regions and municipalities)
.
The alliance covers 28 prefecture-level cities in 16 provinces and 4 national medical reform demonstration counties
.
Shandong Internet Traditional Chinese Medicine (Material) Trading Center, which provides technical and service support for this joint procurement, has established a full-process traceability quality control system in the form of a central quality assurance warehouse with the goal of "guaranteeing quality, upgrading and stabilizing supply".
The traceable source code links upstream and downstream entities to realize automatic data collection, recording and monitoring of the whole process from planting and harvesting to processing, from finished product detection to finished product storage, so as to achieve "one-code traceability"
.
At the same time, the standard for high-quality Chinese herbal medicine pieces was formulated, and through the participation of enterprises in competition, high-quality and affordable Chinese medicine pieces with planting bases and whole-process traceability were selected.
Significantly improved the quality of the decoction pieces
.

Local governments have also taken actions to encourage the clinical use of whole-process traceable decoction pieces
.
Recently, the Shanghai Municipal Health Commission and other 5 departments jointly issued the "Notice on Carrying out the Pilot Work of Clinical Application of Full-process Traceability of Chinese Herbal Pieces in Shanghai", and 5 hospitals and 8 Chinese Herbal Pieces manufacturers in Shanghai took the lead in carrying out the full-process traceability of Chinese Herbal Pieces.
The clinical use of Chinese herbal medicines encourages high quality and high price, and improves the quality of TCM decoction pieces
.

 "Ensuring the consistency and traceability of the quality of each batch of Chinese herbal medicines will become a must for leading Chinese medicine companies in China, and the market competitiveness of 'Dao-produced regions + whole-process traceable pieces' will be further strengthened
," said an expert in the Chinese medicine industry
.
"The industry reshuffle may be gradual, not necessarily cliff-like
.
"