The traditional Chinese medicine formula granule industry has been "spilled with cold water", and the hard practice of internal strength has become a rigid requirement

Traditional Chinese medicine formula granules have the advantages of accurate curative effect and convenient administration.
Starting from November 2021, the management of the approval number of TCM formula granules for more than 20 years has ended, and the trial filing management has begun
.
Since then, the industry has judged that under the implementation of the New Deal, the competitive environment will change, attracting more companies to deploy, and promoting the rapid development of the Chinese medicine formula granule industry.
The future market size of the industry may exceed 100 billion
.
However, the industry enthusiasm under the New Deal has not lasted for a while.
The two ministries and commissions issued the "Notice on Regulating the Clinical Use of TCM Granules in Medical Institutions", which poured cold water on the industry
.
The announcement on the end of the pilot program clarified that the Chinese medicine formula granules should be produced in accordance with the recorded production process and comply with the national drug standards
.
If there are no provisions in the national drug standards, it shall comply with the standards set by the provincial drug regulatory authority
.
Chinese medicine formula granules that do not have relevant standards shall not be marketed
.
The construction of relevant national standards for traditional Chinese medicine formula granules is also accelerating
.
For example, on April 29 this year, the State Food and Drug Administration approved and promulgated the first batch of 160 national drug standards for TCM formula granules; on October 31, the State Food and Drug Administration approved the promulgation of the second batch of 36 TCM formula granules national drug standards.
There are a total of 196 national drug standards for Chinese medicine formula granules that have been approved and promulgated
.
It can be seen that the management of traditional Chinese medicine formula granules is moving towards standardization and standardization.
This notice is mainly used to regulate the use of Chinese medicine formula granules.
It is clear that the health and traditional Chinese medicine authorities at all levels must regulate Chinese medicine in medical institutions.
For the use of formula particles, medical institutions that can provide Chinese medicine services after approval or filing can use Chinese medicine formula particles
.
Regarding the regulations for physicians who prescribe Chinese herbal medicines, the notice clearly stated that only “physicians and village doctors who can prescribe Chinese herbal medicines can prescribe Chinese herbal medicine granules”
.
Public medical institutions using traditional Chinese medicine formula granules shall not contract or lease pharmacies, or trust pharmacies to profit-making enterprises.

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The industry believes that this also means that medical institutions need TCM physicians who "understand" and "understand" TCM expertise to prescribe TCM formula particles, which will help combat medical corruption and ensure the correct and effective use of TCM formula particles
.
In addition, the notice also requires medical institutions to establish a routine monitoring and early warning system for the clinical application of TCM formula granules, and monitor the clinical application of TCM formula granules regularly or irregularly.
Suspected adverse reactions should be reported in time to promote the standardized and reasonable application of TCM formula granules.

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After the above-mentioned requirements appear, the industry believes that the current sales of Chinese medicine formula granules in the hospital may be affected
.
However, some people in the industry pointed out that these requirements are only regulations for the standardized use of Chinese medicine formula granules.
In the past, public hospitals that can prescribe Chinese medicine formula granules are generally equipped with Chinese medicine departments.
Doctors’ medication habits will not change easily.
In addition, many hospitals do not.
Equipped with traditional Chinese medicine formula granules, subsequent sales may usher in growth
.
It is foreseeable that although the market prospects of traditional Chinese medicine formula granules are broad, companies entering this field are also facing higher rigid requirements and technical conditions.
It is not easy to divide the soup.
The situation of big fish eating small fish may continue to appear.
As the industry is moving towards standardization and standardization, enterprises of traditional Chinese medicine formula granules have to work hard on their internal strength and meet hard conditions in order to not be eliminated from the market
.