Implementation of the record management of traditional Chinese medicine formula particles "emerge into a butterfly"

On October 29, the Comprehensive and Planning Finance Department of the State Food and Drug Administration issued a clear notice that the Chinese medicine formula granule varieties will be subject to record management from November 1 this year; the State Food and Drug Administration issued a clear announcement that it will be officially launched on November 1 this year Recording module of traditional Chinese medicine formula particles
.
As early as February this year, the State Food and Drug Administration and other four departments issued an announcement clarifying that the pilot work of traditional Chinese medicine formula granules will be ended, and the varieties of Chinese medicine formula granules will be subject to record management
.
This means that the market is open to all qualified manufacturers, and the Chinese medicine formula granule industry has entered a new stage of development
.
On April 29, the State Food and Drug Administration approved and promulgated the first batch of national drug standards for Chinese medicine formula granules
.
The full liberalization of the market has attracted major pharmaceutical companies across the country to seize the layout
.
In order to further standardize the Chinese medicine formula granule market and ensure the quality of Chinese medicine formula granules, various provincial drug regulatory departments have issued management rules and quality standards for Chinese medicine formula granules
.
With the gradual implementation of regulatory policies, industry insiders believe that Chinese medicine formula granules will "emerge into butterflies
.
" Liberalization of market access, pharmaceutical companies have deployed in February this year, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission, and the National Medical Insurance Administration jointly issued the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (hereinafter referred to as " The Announcement) clarified that starting from November 1 this year, Chinese medicine formula granule varieties will be subject to record management, and no approval number management will be implemented.
The manufacturer will report to the local provincial drug supervision and administration department for record before it goes on the market
.
According to the "Announcement", if the varieties of Chinese medicine decoction pieces have been included in the scope of medical insurance payment, each provincial medical insurance department can comprehensively consider factors such as clinical needs, fund payment ability and price, and after expert review, will include the TCM formula particles corresponding to the Chinese medicine decoction pieces into the payment scope , And refer to Type B management
.
With the full liberalization of the market and the support of medical insurance policies, the market prospects for Chinese medicine formula granules are promising, attracting many pharmaceutical companies
.
China Traditional Chinese Medicine Holdings Co.
, Ltd.
(hereinafter referred to as Chinese Medicine Holdings) owns two national pilot enterprises of traditional Chinese medicine formula granules, Tianjiang Pharmaceutical and Guangdong Yifang Pharmaceutical
.
According to the 2021 mid-term report issued by TCM Holdings, the company is actively welcoming the implementation of the new policy for TCM formula particles by building the entire industrial chain of TCM; as of June 30, TCM Holdings has 17 subsidiaries that have adapted to the new policy for TCM formula particles
.
Tianjin Hongri Pharmaceutical Co.
, Ltd.
(hereinafter referred to as Hongri Pharmaceutical) is also one of the beach rushers that has attracted much attention
.
In June of this year, Hongri Pharmaceutical announced an investment of 750 million yuan to build an intelligent manufacturing base of traditional Chinese medicine formula particles in Shandong, which is already its eighth production base
.
The 2021 mid-term report issued by Shenwei Pharmaceutical Group Co.
, Ltd.
shows that the group is working hard to expand the production capacity of traditional Chinese medicine formula granules to an annual output value of 4 billion yuan, which is expected to be completed by the end of this year
.
China Resources Sanjiu Pharmaceutical Co.
, Ltd.
produces more than 600 varieties of formula granules.
Its 2021 semi-annual report shows that in the face of the new competitive environment brought by the end of the trial of Chinese medicine formula granules, the company is accelerating the layout of the entire industry chain
.
Refining management requirements and raising technical thresholds After the announcement of the "Announcement", various provincial drug regulatory authorities have successively issued rules for the management of traditional Chinese medicine formula granules
.
On July 1, the "Shaanxi Province Traditional Chinese Medicine Formula Granule Management Rules (Trial)" was released
.
Since then, more than 20 provinces (autonomous regions and municipalities directly under the Central Government) including Hainan, Jiangsu, Sichuan, Beijing, Jilin, Anhui, Guizhou, and Jiangxi have successively issued management rules
.
At the same time, the regulatory authorities formulate and issue relevant standards to raise the production technology threshold and product quality requirements of enterprises in order to promote the standardization and standardization of the traditional Chinese medicine formula granule industry
.
According to the "Announcement", Chinese medicine formula granules should be produced in accordance with the recorded production process and comply with national drug standards
.
If there is no provision in the national drug standards, it shall comply with the standards established by the provincial drug regulatory authority
.
On April 29, the State Food and Drug Administration approved and promulgated the first batch of 160 national drug standards for traditional Chinese medicine formula granules; on October 31, approved the promulgation of the second batch of 36 national drug standards for traditional Chinese medicine formula granules
.
It is reported that the national drug standards for the third batch of Chinese medicine formula granules are being accelerated
.
"Implementation of national standards will increase production costs and difficulties for enterprises on the one hand, and on the other hand, it will improve the quality of Chinese medicine formula granules
.
" said Wei Mei, chairman of Guangdong Yifang Pharmaceutical.
The control of the content; the upper and lower limits of the content index are set to make the quality of the traditional Chinese medicine formula particles more stable and uniform
.
"These quality control concepts are in line with the international recognition and requirements for Chinese medicine products, and have laid the foundation for promoting Chinese medicine formula granules to the world
.
" According to Hu Changjiang, technical director of Sichuan New Green Pharmaceutical Technology Development Co.
, Ltd.
and director of the Institute of Pharmaceutical Research, The improvement of standards poses a challenge to small and medium-sized enterprises that have newly entered the Chinese medicine formula granule industry
.
The provincial drug regulatory departments are also stepping up the formulation and release of standards for Chinese medicine prescription granules
.
On October 27, the Beijing Municipal Food and Drug Administration issued the "Beijing Chinese Medicine Formula Granule Standards (First Batch)".
The first batch of 121 TCM formula granules standards was implemented on November 1
.
The Food and Drug Administration of more than 10 provinces (autonomous regions and municipalities directly under the Central Government), including Shaanxi, Shandong, and Shanghai, have successively issued provincial-level standards for traditional Chinese medicine formulation granules
.
With the gradual introduction of provincial standards, mutual recognition of provincial standards has become the focus of attention in the industry
.
On September 16, a seminar on the mutual recognition of provincial standards for traditional Chinese medicine formula granules was held in Longxi County, Gansu Province.
Representatives from the Food and Drug Administration of 10 provinces (autonomous regions and municipalities directly under the Central Government) and related enterprises, including Gansu, Guangdong, Shandong, and Zhejiang, focused on the province of Chinese medicine formula granules.
The level standard research work was exchanged
.
The meeting recommended to speed up the development of guidelines for mutual recognition of provincial standards for Chinese medicine prescription granules, and establish a provincial standard joint construction and sharing mechanism
.
Strengthen scientific supervision and promote industrial development In the context of market liberalization and higher technical thresholds, the State Food and Drug Administration has further accelerated the process of overall standardized management of the industry
.
On October 29, the "Notice of the Comprehensive Department of the State Drug Administration on Matters Concerning the Filing of Chinese Medicine Formula Granules" (hereinafter referred to as the "Notice") was issued
.
The "Notice" requires that the varieties of Chinese medicine formula granules should be filed through the "Online Office of the State Drug Administration" and "Pharmaceutical Business Application System-Chinese Medicine Formula Granule Recording Module" before being marketed, and the record number shall be obtained
.
Speeding up variety filing has become an urgent task for Chinese medicine formula granule enterprises
.
"The implementation of the filing system meets the requirements of the reform of
decentralization , regulation and service and the needs of industrial development, and is conducive to guiding the orderly development and fair competition of the traditional Chinese medicine formula granule market .
" said Zhang Zhiqiang, R&D director of Beijing Kangrentang Pharmaceutical Co.
, Ltd.
, "Kangrentang is in full swing.
Carry out the filing work
.
” The "Notice" requires that all provincial drug administration departments shall publish relevant information on the website of the State Drug Administration within 5 days from the date of the creation of the filing number for public inquiries
.
Hu Changjiang believes that the disclosure of relevant information is convenient for users and other companies to inquire, making the information more open and transparent, and also convenient for social supervision
.
The relevant information of traditional Chinese medicine formula granules is uniformly announced to provide decision-making reference for enterprises that have or will deploy Chinese medicine formula granules.
Fair competition can promote the healthy and orderly development of the Chinese medicine formula granule industry
.
Filing does not mean to relax the supervision of Chinese medicine formula particles, but to control risks by strengthening supervision during and after the event
.
The "Notice" proposes that the filing information of traditional Chinese medicine formula granules shall not be changed at will.
The registered Chinese medicine formula granules involve the production process (including excipients), quality standards, packaging materials, production address and other information that affects the quality of traditional Chinese medicine formula granules.
, Should be reported to the provincial drug regulatory department where the Chinese medicine formula granule production enterprise is located for the record according to the procedures and requirements
.
In addition, the filing data of Chinese medicine formula granules can be used for supervision and inspection and extended inspection by the drug regulatory department.
If the filing data is found to be untrue, the filing data is inconsistent with the actual production and sales situation, the provincial drug The supervisory department shall cancel the record and disclose relevant information in the record module of Chinese medicine formula granules
.
With the advancement of policies related to Chinese medicine formula granules, Wei Mei believes that in the future, the Chinese medicine formula granule industry will continue to develop in the direction of standardization and achieve high-quality industrial development
.